[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Medtronic Cardiac Ablation Solutions\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":291},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,52,80,101,120,139,163,194,229,252,270],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100570149","safety-and-performance-assessment-of-the-sphere-9-catheter-and-affera-ablation-system-for-the-treatment-of-ventricular-tachycardia-sphere-9-vt-efs-100570149",false,"NCT06703489","Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS)","Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia","Inclusion Criteria:\n\n1. Any of the following:\n\n   1. Ischemic cardiomyopathy (ICM) patients with prior history of myocardial infarction (MI).\n   2. Non-ischemic cardiomyopathy (NICM) patients with documented myocardial scar in a territory without coronary stenosis as evidenced by cardiac imaging.\n2. At least one episode of sustained (continuous for \\>30 seconds or requiring ICD intervention for termination) monomorphic ventricular tachycardia within the 6 months prior to enrollment.\n3. Recurrence of sustained ventricular tachycardia despite class I or III antiarrhythmic drug therapy or ICD intervention.\n4. Implanted with an implantable cardiac defibrillator (ICD) or CRT-D for at least 3 months prior to the ablation procedure.\n5. Age 18 through 85 years old.\n6. Willing and able to provide informed consent.\n7. Willing and able to comply with all pre-, post-, and follow-up testing requirements.\n\nExclusion Criteria:\n\n1. Incessant VT necessitating hemodynamic support prior to the ablation procedure.\n2. Unstable polymorphic VT or ventricular fibrillation (VF).\n3. VTs due to any of the following:\n\n   1. Idiopathic VT\n   2. Automaticity or triggered activity\n   3. Lamin or titin genetic mutation\n   4. Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause (e.g., drug induced arrhythmia).\n4. NICM subjects with active inflammatory processes (e.g., myocarditis) within 120 days prior to the ablation procedure.\n5. VT or VF thought to be from channelopathies.\n6. More than two prior VT ablations at any time, more than one prior VT ablation within 12 months prior to the ablation procedure, or any VT ablation within 4 weeks prior to the ablation procedure.\n7. Sarcoidosis.\n8. Hypertrophic cardiomyopathy, except when due to an apical aneurysm.\n9. Unstable angina.\n10. Active myocardial ischemia.\n11. Type 1 myocardial infarction within 2 months (60 days) prior to the ablation procedure.\n12. Any percutaneous coronary intervention within 2 months (60 days) prior to the ablation procedure.\n13. Any cardiac surgery within 3 months (90 days) prior to the ablation procedure.\n14. Left ventricular ejection fraction (LVEF) \\\u003C15%.\n15. NYHA Class IV heart failure.\n16. Decompensated heart failure.\n17. Currently receiving support, or anticipated to receive support prior to the index ablation procedure, via extracorporeal membrane oxygenation (ECMO).\n18. Ventricular assist device (VAD) implanted, planned or required for the procedure.\n19. Severe aortic or mitral stenosis, or severe aortic or mitral regurgitation.\n20. Presence of prosthetic valve in the aortic or mitral valve.\n21. Patients with advanced COPD (on home oxygen).\n22. Presence of intracardiac thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation.\n23. Thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the index ablation procedure or with neurologic deficit.\n24. Left atrium (LA) or left ventricle (LV) intracardiac thrombus on imaging.\n25. Severe bleeding, clotting or thrombotic disorder, or thrombocytopenia (defined as platelet count \\\u003C80,000).\n26. Contraindication to anticoagulation.\n27. End-stage renal disease (requiring dialysis).\n28. Acute illness, active infection, or sepsis.\n29. Life expectancy less than 12 months.\n30. Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence.\n31. Body mass index \\>45 kg\u002Fm2.\n32. Known ongoing drug or alcohol dependency.\n33. Current or anticipated participation in any other ongoing study of a drug, device, or biologic during the duration of the study not pre-approved by the Sponsor.\n34. Vulnerable subjects (such as a prisoner, handicapped or mentally disabled person, or person under tutelage or guardianship).\n35. Any other condition that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would pose a significant hazard to the subject if an ablation procedure were performed.","ALL","18 Years","85 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","Sphere-9 VT EFS is a prospective, multi-center, non-randomized, unblinded feasibility study. Adult subjects with recurrent, sustained, scar-related monomorphic ventricular tachycardia will be enrolled and treated with the Sphere-9 Catheter and Affera Ablation System.",[27],"Ventricular Tachycardia (VT)",[29,30,31,32,33,34,35,36,37,38],"Recurrent sustained monomorphic ventricular tachycardia","Monomorphic ventricular tachycardia","Ventricular tachycardia","Arrhythmias, Cardiac","Heart Diseases","Cardiovascular Diseases","Pathologic Processes","Ischemic heart disease","Patient with Implantable Cardioverter Defibrillator (ICD)","Ischemic cardiomyopathy","RECRUITING","2026-06-15",{"date":42,"type":43},"2026-06-16","ACTUAL",{"date":45,"type":43},"2025-03-18",{"date":47,"type":21},"2027-01",{"name":49,"class":50},"Medtronic Cardiac Ablation Solutions","INDUSTRY",6,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100616687","horizon-360-protocol-for-the-treatment-of-paroxysmal-atrial-fibrillation-with-the-sphere-360-catheter-and-affera-mapping-and-ablation-system-horizon-360-100616687","NCT07308847","Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)","Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Prospective, Single Arm, Unblinded Pre-market Clinical Study to Evaluate the Safety and Effectiveness of the Sphere-360 Catheter and Affera Mapping and Ablation System for Treating Paroxysmal Atrial Fibrillation (PAF)","Horizon 360","Inclusion Criteria:\n\n1. A diagnosis of recurrent symptomatic PAF, which is defined as continuous AF episode lasting longer than 30 seconds but terminates spontaneously or with intervention within 7 days of onset, documented by the following:\n\n   1. a physician's note indicating at least 2 symptomatic PAF episodes occurring within 6 months prior to enrollment; and\n   2. at least 1 electrocardiographically documented episode within 12 months prior to enrollment\n2. Adults who are ≥18 and ≤80 years of age on the day of enrollment.\n3. Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.\n\nExclusion Criteria:\n\n1. Continuous AF lasting more than 7 days. This includes persistent atrial fibrillation (PsAF) (both early or long-standing) by diagnosis or continuous duration \\> 7 days\n2. AF that required three (3) or more distinct cardioversions in the preceding 12 months.\n3. LA anteroposterior \\> 5.0 cm (by MRI, CT, or TTE)\n4. Any of the following procedures, implants, or conditions at baseline: prior left atrial catheter or surgical ablation, prior left atrial percutaneous interventions including left atrial appendage occlusion, and septal closure devices\n5. Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, loop recorder\u002Finsertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during the follow-up period\n6. Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure\n7. Presence of a permanent pacemaker, biventricular pacemaker, loop recorder\u002Finsertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)\n8. Presence of any pulmonary vein stents\n9. Known pre-existing pulmonary vein stenosis\n10. Pre-existing hemidiaphragmatic paralysis\n11. Prior valvular (surgical or percutaneous) procedure including prosthetic, bioprosthetic, valve replacement, valve repair or valvuloplasty, and any prior atriotomy\n12. Moderate to severe aortic or mitral valve stenosis\n13. Moderate to severe mitral regurgitation (i.e., 3+ or 4+ MR)\n14. Any cardiac surgery, myocardial infarction, PCI \u002F PTCA or coronary artery stenting which occurred during the 3-month interval preceding the consent date\n15. Unstable angina\n16. NYHA Class III or IV congestive heart failure or documented left ventricular ejection fraction (LVEF) less than or equal to 40% measure by acceptable cardiac testing (e.g. TTE), or planned transplant or left ventricular assist device (LVAD)\n17. Severe lung disease, primary pulmonary hypertension, or any lung disease with abnormal blood gases or requiring supplemental oxygen\n18. Rheumatic heart disease\n19. Severe thrombocytosis, thrombocytopenia, or any bleeding or clotting disorder\n20. Contraindication to or unwillingness to use systemic anticoagulation\n21. Documented left atrial thrombus on imaging\n22. Active systemic infection or sepsis\n23. Hypertrophic cardiomyopathy\n24. Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, and acute alcohol toxicity\n25. Any cerebral ischemic event (strokes or TIAs) which occurred during the 6-month interval preceding the consent date\n26. Carotid stenting or endarterectomy\n27. History of thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure\n28. Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence\n29. Patient with life expectancy that makes it unlikely 12 months of follow-up will be completed\n30. Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic\n31. Known allergies or hypersensitivities to adhesives\n32. Body mass index \\> 40 kg\u002Fm2\n33. Atrial myxoma\n34. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.\n35. Renal insufficiency with an estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m2, or any history of renal failure requiring dialysis or renal transplant\n36. Solid organ or hematologic transplant, or currently being evaluated for an organ transplant\n37. Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation\n38. Known drug or alcohol dependency\n39. Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would impact the scientific soundness of the clinical trial results.\n40. Treatment with Amiodarone within the 3 months prior to enrollment\n41. Amyloid heart disease (cardiac amyloidosis)","80 Years",{"count":62,"type":21},300,[24],"The study is a prospective, single-arm, pre-market clinical study and will enroll up to 300 subjects at up to 26 sites in the United States (US) for analysis of primary objectives. No single site may contribute more than 15% of the enrollments.",[66],"Paroxysmal AF",[68,69,70],"Paroxysmal Atrial Fibrillation","Atrial Fibrillation","Pulsed Field Ablation","2026-06-10",{"date":73,"type":43},"2026-06-12",{"date":75,"type":43},"2026-01-15",{"date":77,"type":21},"2027-11-22",{"name":49,"class":50},22,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100560512","pulsed-af-post-approval-study-100560512","NCT06578104","PULSED AF Post-Approval Study","PULSED AF Post-Approval Study, an Addendum to the PulseSelect™ PFA Global Registry","Inclusion Criteria\n\n* A diagnosis of recurrent symptomatic paroxysmal AF or persistent AF\n* Refractory to at least one Class I or III antiarrhythmic drug (i.e., not effective, not tolerated, or not desired)\n* Patient is ≥ 18 years of age\n* Planned pulmonary vein isolation procedure with the commercially available PulseSelect™ PFA System\n* Willing and able to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements\n\nExclusion Criteria\n\n* Long-standing persistent AF (continuous AF sustained \\>12 months)\n* Prior left atrial catheter or surgical ablation\n* Patient with life expectancy \\\u003C 36 months\n* Presence of a permanent pacemaker, biventricular pacemaker, loop recorder\u002Finsertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)\n* Current or anticipated participation in any other clinical trial of a drug, device, or biologic not approved by the global study manager",{"count":88,"type":21},580,"OBSERVATIONAL","PULSED AF PAS is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months.",[69],"2026-05-22",{"date":94,"type":43},"2026-05-27",{"date":96,"type":43},"2024-11-04",{"date":98,"type":21},"2029-06-01",{"name":49,"class":50},18,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":108,"targetDuration":110,"studyType":89,"phases":4,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":113,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},"100546360","pulseselect-pfa-global-registry-100546360","NCT06393920","PulseSelect™ PFA Global Registry","PulseSelect PFA Global Registry, a Part of the Medtronic Cardiac Ablation Post-Market Study Platform","Inclusion Criteria:\n\n* Subject is ≥ 18 years of age or minimum age as required by local regulations.\n* Subject has been diagnosed with atrial fibrillation (AF)\n* Planned procedure using commercially available PulseSelect™ PFA System.\n* Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements.\n\nExclusion Criteria:\n\n* Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager.\n* Subject with exclusion criteria required by local law.",{"count":109,"type":21},1950,"12 Months","The PulseSelect™ PFA Global Registry is a prospective, global, multi-center, observational post-approval study. Subjects will be treated with the PulseSelect™ PFA System and followed according to SOC.",[69],{"date":94,"type":43},{"date":115,"type":43},"2024-07-23",{"date":117,"type":21},"2027-07-01",{"name":49,"class":50},37,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},"100456704","stop-af-first-post-approval-study-100456704","NCT05227053","STOP AF First Post-Approval Study","STOP AF First Post-Approval Study, an Addendum to the Cryo Global Registry","Inclusion Criteria:\n\n* Subject has been diagnosed with symptomatic paroxysmal AF\n* Subject is ≥ 18 years of age or minimum age as required by local regulations\n* Planned pulmonary vein isolation (PVI) procedure using the commercially available Arctic Front™ cardiac cryoablation catheter System.\n* Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements\n\nExclusion Criteria:\n\nHistory of AF treatment with a class I or III antiarrhythmic drug, including sotalol, with the intention to prevent an AF recurrence1\n\n. Subjects under the following conditions may be included in the study:\n\n1. Temporary treatment with a class I or III AAD (treatment at a therapeutic dose for a period of \\\u003C4 weeks prior to the index PVI procedure)\n2. Recent treatment with a class I or III AAD (within 6 months of the index PVI procedure) at a dose below therapeutic threshold according to the AHA\u002FACC\u002FHRS Guideline for the Management of Patients with Atrial Fibrillation\n3. A subject who has received a chemical cardioversion may be included in the study. This includes a chemical cardioversion prior to enrollment and between enrollment and ablation.\n\n   * Subject has had a prior atrial ablation (except for cavo-tricuspid isthmus (CTI) ablation for AFL)\n   * Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager\n   * Subject with exclusion criteria required by local law",{"count":128,"type":21},200,"The STOP AF First PAS is a prospective, global, multi-center, observational trial.",[68],"2026-05-19",{"date":92,"type":43},{"date":134,"type":43},"2022-04-28",{"date":136,"type":21},"2028-04",{"name":49,"class":50},13,{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":148,"briefSummary":149,"conditions":150,"keywords":152,"overallStatus":154,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":4},"100639770","safety-and-effectiveness-of-the-sphere-9-catheter-and-affera-ablation-system-for-the-treatment-of-ventricular-tachycardia-sphere-vt-100639770","NCT07585968","Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)","Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia","Inclusion Criteria:\n\n1. Prior myocardial infarction (MI).\n2. At least one episode of sustained (continuous for \\>30 seconds or requiring ICD intervention for termination) monomorphic ventricular tachycardia within the 6 months prior to enrollment.\n3. Recurrence of sustained ventricular tachycardia despite Class I or III antiarrhythmic drug therapy or ICD intervention.\n4. Implanted with an implantable cardiac defibrillator (ICD) or CRT-D for at least 2 months prior to the ablation procedure.\n5. Age 18 through 85 years old.\n6. Willing and able to provide informed consent.\n7. Willing and able to comply with all pre-, post-, and follow-up testing requirements.\n\nExclusion Criteria:\n\n1. Incessant VT necessitating hemodynamic support prior to the ablation procedure.\n2. Unstable polymorphic VT or ventricular fibrillation (VF).\n3. Idiopathic VT or VT of non-ischemic cardiomyopathy.\n4. VT secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause (e.g., drug-induced arrhythmia).\n5. VT or VF thought to be from channelopathies.\n6. More than two prior VT ablations at any time, more than one prior VT ablation within 12 months prior to the ablation procedure, or any VT ablation within 4 weeks prior to the ablation procedure.\n7. Sarcoidosis.\n8. Hypertrophic cardiomyopathy, except when due to an apical aneurysm.\n9. Unstable angina.\n10. Active myocardial ischemia.\n11. Type 1 myocardial infarction within 2 months (60 days) prior to the ablation procedure.\n12. Any percutaneous coronary intervention performed in a setting of unstable angina or acute MI (STEMI or non-STEMI) within 2 months (60 days) prior to the ablation procedure. Note: elective PCI performed during elective angiogram would be excluded only if occurring within 30 days prior to the ablation procedure.\n13. Any cardiac surgery within 2 months (60 days) prior to the ablation procedure. Note: ICD lead implant\u002Freplacement falls under this exclusion, but ICD generator-only replacement does not.\n14. Left ventricular ejection fraction (LVEF) \\\u003C15%.\n15. NYHA Class IV heart failure.\n16. Decompensated heart failure.\n17. Extravascular ICD (EV-ICD) or subcutaneous ICD (S-ICD)\n18. Currently receiving support, or anticipated to receive support prior to the index ablation procedure, via extracorporeal membrane oxygenation (ECMO).\n19. Circulatory\u002Fventricular assist device (VAD; surgical or percutaneous) implanted, planned or required for the procedure.\n20. Severe aortic or mitral stenosis, or severe aortic or mitral regurgitation.\n21. Presence of prosthetic valve in the aortic or mitral valve.\n22. Patients with advanced COPD (on home oxygen).\n23. Presence of intracardiac tumor or other abnormality that precludes vascular access, catheter introduction, or manipulation.\n24. Thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the index ablation procedure or with neurologic deficit.\n25. Left atrium (LA) or left ventricle (LV) intracardiac thrombus on imaging.\n26. Severe bleeding, clotting or thrombotic disorder, or thrombocytopenia (defined as platelet count \\\u003C80,000).\n27. Contraindication to anticoagulation.\n28. End-stage renal disease (requiring dialysis).\n29. Acute illness, active infection, or sepsis.\n30. Life expectancy less than 12 months.\n31. Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence.\n32. Body mass index \\>45 kg\u002Fm2.\n33. Known ongoing drug or alcohol dependency.\n34. Current or anticipated participation in any other ongoing study of a drug, device, or biologic during the duration of the study not pre-approved by the Sponsor.\n35. Vulnerable subjects (such as a prisoner, handicapped or mentally disabled person, or person under tutelage or guardianship).\n36. Any other condition that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would pose a significant hazard to the subject if an ablation procedure were performed.",{"count":147,"type":21},260,[24],"Sphere VT is a prospective, multi-center, single-arm, unblinded pivotal clinical study. Adult subjects with recurrent, sustained, monomorphic ventricular tachycardia (MMVT) due to prior myocardial infarction (MI) will be enrolled and treated with the Sphere-9 Catheter and Affera Ablation System.",[151],"Ventricular Tachycardia",[153,31,32,33,34,35,36,37,38],"Recurrent sustained scar-related monomorphic ventricular tachycardia","NOT_YET_RECRUITING","2026-05-07",{"date":157,"type":43},"2026-05-14",{"date":159,"type":21},"2026-06",{"date":161,"type":21},"2028-09",{"name":49,"class":50},{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":60,"enrollmentInfo":171,"targetDuration":4,"studyType":22,"phases":173,"briefSummary":174,"conditions":175,"keywords":178,"overallStatus":154,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":4},"100638209","outcomes-of-an-optimized-workflow-with-pulseselect-pulsed-field-ablation-pfa-system-in-paroxysmal-and-persistent-atrial-fibrillation-100638209","NCT07575828","Outcomes of an Optimized Workflow With PulseSelect Pulsed Field Ablation (PFA) System in Paroxysmal and Persistent Atrial Fibrillation","Outcomes of an Optimized Workflow With PulseSelect Pulsed Field Ablation (PFA) System in Paroxysmal and Persistent Atrial Fibrillation (NEXT PULSE)","NEXT PULSE","Inclusion Criteria:\n\n1. Adults who are ≥18 and ≤80 years of age on the day of enrollment (or older than 18 if required by local law)\n2. A diagnosis of recurrent symptomatic paroxysmal or persistent AF:\n\n   Symptomatic paroxysmal AF: AF that terminates spontaneously or with intervention within 7 days of onset, documented by the following:\n   1. Physician's note indicating at least 2 symptomatic paroxysmal AF episodes occurring within 12 months prior to enrollment; AND\n   2. at least 1 ECG documented AF episode from any form of rhythm monitoring within 12 months prior to enrollment.\n\n   Symptomatic persistent AF: Continuous AF sustained beyond 7 days and less than 1 year, documented by the following:\n   1. Physician's note indicating at least 1 symptomatic persistent AF episode occurring within 12 months prior to enrollment; AND\n   2. any 24-hour continuous ECG recording documenting continuous AF within 12 months prior to enrollment; OR 2 ECGs from any form of rhythm monitoring taken at least 7 days apart, both showing continuous AF within 12 months prior to enrollment\n3. Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.\n\nExclusion Criteria:\n\n1. Long-standing persistent AF (continuous AF that is sustained \\>12 months)\n2. Paroxysmal AF patients: AF that required three (3) or more distinct cardioversions in the preceding 12 months.\n3. Paroxysmal AF: LA anteroposterior diameter \\> 5.0 cm (by MRI, CT, or TTE) Persistent AF: LA anteroposterior diameter \\> 5.5 cm (by MRI, CT, or TTE)\n4. Any of the following procedures, implants, or conditions at baseline: prior left atrial catheter or surgical ablation, prior left atrial percutaneous interventions including left atrial appendage occlusion, and septal closure devices\n5. Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, loop recorder\u002Finsertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during the follow-up period\n6. Presence of a permanent pacemaker, biventricular pacemaker, loop recorder\u002Finsertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)\n7. Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure\n8. Contraindication to or unwillingness to use systemic anticoagulation\n9. Presence of any pulmonary vein stents\n10. Known pre-existing pulmonary vein stenosis\n11. Prior valvular (surgical or percutaneous) procedure including prosthetic, bioprosthetic, valve replacement, valve repair or valvuloplasty, and any prior atriotomy\n12. Moderate to severe mitral valve or aortic stenosis\n13. Moderate to severe mitral regurgitation (i.e., 3+ or 4+ MR)\n14. Any cardiac surgery, myocardial infarction, PCI \u002F PTCA or coronary artery stenting which occurred during the 3-month interval preceding the consent date\n15. Unstable angina\n16. NYHA Class III or IV congestive heart failure or documented left ventricular ejection fraction (LVEF) less than or equal to 40% measure by acceptable cardiac testing (e.g. TTE), or planned transplant or left ventricular assist device (LVAD)\n17. Severe lung disease, primary pulmonary hypertension, or any lung disease abnormal blood gases or requiring supplemental oxygen\n18. Rheumatic heart disease\n19. Severe thrombocytosis, thrombocytopenia, or any bleeding or clotting disorder\n20. Documented left atrial thrombus on imaging\n21. Active systemic infection or sepsis\n22. Hypertrophic cardiomyopathy\n23. Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, and acute alcohol toxicity\n24. Any cerebral ischemic event (strokes or TIAs) which occurred during the 6-month interval preceding the consent date\n25. Carotid stenting or endarterectomy\n26. History of thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure\n27. Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence\n28. Patient with life expectancy that makes it unlikely 12 months of follow-up will be completed\n29. Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic\n30. Known allergies or hypersensitivities to adhesives\n31. Body mass index \\> 40 kg\u002Fm2\n32. Atrial myxoma\n33. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.\n34. Renal insufficiency with an estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m2, or any history of renal failure requiring dialysis or renal transplant\n35. Solid organ or hematologic transplant, or currently being evaluated for an organ transplant\n36. Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation\n37. Known drug or alcohol dependency\n38. Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would impact the scientific soundness of the clinical trial results\n39. Amyloid heart disease (cardiac amyloidosis)",{"count":172,"type":21},320,[24],"The NEXT PULSE study is a pre-market, prospective, multi-center, non-randomized, interventional clinical study. Adult subjects with symptomatic paroxysmal or persistent AF who provided consent will be enrolled and treated with the PulseSelect PFA System.",[176,177],"Paroxysmal Atrial Fibrillation (PAF)","Persistent Atrial Fibrillation",[179,66,180,181,182,183,70,184,185],"Atrial Fibrillation (AF)","Persistent AF","Symptomatic recurrent AF","Arrhythmia","PulseSelect PFA System","Catheter ablation","Pulmonary Vein Ablation","2026-05-04",{"date":188,"type":43},"2026-05-08",{"date":190,"type":21},"2026-08",{"date":192,"type":21},"2029-03",{"name":49,"class":50},{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":204,"conditions":205,"keywords":206,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":228},"100615889","conquer-af-protocol-for-redo-ablation-procedures-in-recurrent-paroxysmal-and-persistent-atrial-fibrillation-using-the-sphere-9-catheter-and-affera-ablation-system-conquer-af-100615889","NCT07298473","Conquer-AF Protocol for Redo Ablation Procedures in Recurrent Paroxysmal and Persistent Atrial Fibrillation Using the Sphere-9 Catheter and Affera Ablation System (Conquer-AF)","Conquer-AF","Inclusion Criteria:\n\n* 1\\. History of a single AF ablation procedure for PAF or PsAF within 3 years prior to enrollment 2. Documented evidence of symptomatic AF, AT or AFL recurrence at least 90 days after subject's de novo ablation procedure, as demonstrated by:\n\n  * A physicians' note indicating at least 1 symptomatic AF, AT, or AFL episode occurring within 12 months prior to the enrollment; and\n  * At least 1 electrocardiographically documented episode of AF, AT, or AFL within 12 months prior to enrollment 3. Adults who are ≥18 years of age on the day of enrollment 4. Willing and able to comply with all study requirements and provide informed consent\n\nExclusion Criteria:\n\n* 1\\. Continuous AF lasting for 12 months or longer 2. LA anteroposterior \\>55 mm (by MRI, CT, or TTE), or if LA diameter not available, non-index volume \\>100 mL for PsAF subjects; OR LA anteroposterior \\>50 mm (by MRI, CT, or TTE), or if LA diameter not available, non-index volume \\>95 mL for PAF subjects 3. Previous left atrial percutaneous interventions including left atrial appendage occlusion and septal closure devices 4. Planned left atrial appendage (LAA) closure procedure, cardiac transplantation or implant of a permanent pacemaker, biventricular pacemaker, loop recorder\u002Finsertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during the follow-up period 5. More than 1 previous AF ablation procedure 6. Any prior surgical ablation procedure 7. Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure 8. Contraindication to or unwillingness to use systemic anticoagulation 9. Severe thrombocytosis, thrombocytopenia, or any bleeding or clotting disorder 10. Presence of a permanent pacemaker, biventricular pacemaker, loop recorder\u002Finsertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) 11. Presence of any pulmonary vein stents 12. Known pre-existing pulmonary vein stenosis 13. Pre-existing hemidiaphragmatic paralysis 14. Prior valvular (surgical or percutaneous) procedure including prosthetic, bioprosthetic, valve replacement, valve repair or valvuloplasty, or any prior atriotomy 15. Moderate to severe mitral valve or aortic stenosis 16. Moderate to severe mitral regurgitation (i.e., 3+ or 4+ MR) 17. Any cardiac surgery, myocardial infarction, PCI\u002FPTCA or coronary artery stenting which occurred within the 3 months preceding the consent date 18. NYHA Class III or IV congestive heart failure 19. Documented left ventricular ejection fraction (LVEF) ≤40%, measured by acceptable cardiac testing (e.g., TTE) 20. Unstable angina 21. Severe lung disease, primary pulmonary hypertension, or any lung disease requiring supplemental oxygen 22. Rheumatic heart disease 23. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition 24. Presence of left atrial thrombus on imaging 25. Active systemic infection or sepsis 26. Hypertrophic cardiomyopathy 27. Amyloid heart disease 28. Diagnosed atrial myxoma 29. Known reversible causes of AF (e.g., uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, acute alcohol toxicity or other reversible or non-cardiac cause) 30. Any cerebral ischemic event (strokes or TIAs) which occurred within the preceding 6 months of the consent date through the date of study index redo ablation procedure 31. Carotid stenting or endarterectomy 32. Thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure 33. Body mass index \\> 40 kg\u002Fm2 34. Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence\\* 35. Patient with life expectancy that makes it unlikely 12 months of follow-up will be completed 36. Current or anticipated participation in any other clinical study of a drug, device or biologic during the duration of the study not pre-approved by Medtronic 37. Renal insufficiency with an estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m2, or any history of renal failure requiring dialysis or renal transplant 38. Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation 39. Presence of an inferior vena cava (IVC) filter (e.g., Greenfield or similar) that would preclude safe transfemoral venous access, catheter passage, or sheath manipulation.\n\n  40\\. Known drug or alcohol dependency 41. Significant congenital anomaly or medical problem that would, in the opinion of the investigator, preclude enrollment, follow-up compliance, or the scientific integrity of the study\n\n  \\*Women who are of child-bearing potential must undergo a pregnancy test after consent and prior to the study index redo ablation procedure, as allowed according to local regulations",{"count":202,"type":21},400,[24],"Conquer-AF is a prospective, multi-center, interventional, non-randomized clinical study that will enroll up to 400 subjects at up to 30 sites across the United States, Europe, and Australia.\n\nSubjects diagnosed with symptomatic recurrent paroxysmal or persistent atrial fibrillation after a single prior ablation procedure will be enrolled in this study. Each subject will undergo a study index redo ablation procedure using the Sphere-9 Catheter and Affera Ablation System and will be followed for 12 months. The expected total study duration (from time of first enrollment to the exit of last enrolled subject) is approximately 2 years.",[179,177,176],[207,208,209,210,211,212,69,68,177,213,214,215,216,217,218,219],"Sphere-9 Catheter","Affera Ablation System","Affera Mapping System","Pulsed Field Ablation (PFA)","Radiofrequency Ablation (RFA)","Dual-Energy Ablation","Redo Ablation","Repeat Ablation","Electrophysiology Mapping","3D Cardiac Mapping","Left Atrial Ablation","Redo AF Ablation","Repeat Ablation Procedures","2026-04-09",{"date":222,"type":43},"2026-04-13",{"date":224,"type":43},"2026-04-08",{"date":226,"type":21},"2028-03-29",{"name":49,"class":50},30,{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":237,"enrollmentInfo":238,"targetDuration":4,"studyType":22,"phases":240,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":251},"100450362","safety-and-performance-of-the-spherepvi-catheter-to-treat-paroxysmal-atrial-fibrillation-100450362","NCT05144503","Safety and Performance of the SpherePVI™ Catheter to Treat Paroxysmal Atrial Fibrillation","A Safety and Performance Assessment of the SpherePVI™ Catheter and the Affera Mapping and Ablation System to Treat Paroxysmal Atrial Fibrillation","SpherePVI","Inclusion Criteria:\n\n1. Symptomatic paroxysmal or persistent atrial fibrillation documented by:\n\n   * A physician's note indicating recurrent AF\n   * At least two electrocardiographically documented AF episodes within 12 months prior to enrollment\n2. Failure or intolerance of at least one Class I-IV anti-arrhythmic drug.\n3. Suitable candidate for catheter ablation.\n4. Age ≥ 18 and \\\u003C 75 years.\n5. Able and willing to give informed consent.\n6. Able and willing, and has ample means to comply with all pre-procedure, post-procedure and follow-up testing requirements\n\nExclusion Criteria:\n\nSubjects will not be eligible for the study if any of the following criteria are met:\n\n1. Continuous AF lasting more than 12 months (long-standing persistent AF).\n2. AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or reversible or non-cardiac cause.\n3. Previous left atrial catheter or surgical ablation (including septal closure or left atrial appendage closure).\n4. Valvular cardiac surgical\u002Fpercutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).\n5. Any carotid stenting or endarterectomy.\n6. Any cardiac procedure (surgical or percutaneous) or percutaneous coronary intervention within 90 days prior to the initial procedure.\n7. Coronary artery bypass graft (CABG) procedure within the 6 months prior to the index ablation procedure.\n8. Awaiting cardiac transplantation or other cardiac surgery within 12 months following the initial ablation procedure.\n9. Presence of any type of implantable cardiac defibrillator (with or without biventricular pacing function).\n10. Documented thromboembolic event (stroke or transient ischemic attack) within the past 6 months (180 days).\n11. Documented left atrial thrombus on imaging.\n12. History of blood clotting or bleeding abnormalities.\n13. Any condition contraindicating chronic anticoagulation.\n14. Myocardial infarction (MI) within the 3 months (90 days) prior to the initial procedure.\n15. Body mass index \\>40 kg\u002Fm2.\n16. Left atrial diameter (anteroposterior) \\>50 mm for paroxysmal AF and \\>55mm for persistent AF.\n17. Diagnosed atrial myxoma.\n18. Left ventricular ejection fraction (EF) \\\u003C 40%.\n19. Uncontrolled heart failure or NYHA Class III or IV heart failure.\n20. Rheumatic heart disease.\n21. Hypertrophic cardiomyopathy.\n22. Unstable angina.\n23. Moderate to severe mitral valve stenosis.\n24. Severe mitral regurgitation (regurgitant volume ≥ 60 mL\u002Fbeat, regurgitant fraction ≥ 50%, and\u002For effective regurgitant orifice area ≥ 0.40cm2).\n25. Primary pulmonary hypertension.\n26. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.\n27. Renal failure requiring dialysis.\n28. Acute illness, active systemic infection, or sepsis.\n29. Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would impact the scientific soundness of the clinical trial results.\n30. Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence.\n31. Current or anticipated participation in any other clinical trial of a drug, device, or biologic during the duration of the study, unless pre-approved by the Sponsor.\n32. Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation.\n33. Known drug or alcohol dependency.\n34. Life expectancy less than 12 months.\n35. Vulnerable subject.","75 Years",{"count":239,"type":21},100,[24],"A prospective, single-arm, single-center study to evaluate the safety, performance, and effectiveness of the SpherePVI™ Catheter for treating paroxysmal AF.",[69],"2026-02-11",{"date":245,"type":43},"2026-02-13",{"date":247,"type":43},"2021-07-22",{"date":249,"type":21},"2027-10-15",{"name":49,"class":50},1,{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":235,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":237,"enrollmentInfo":259,"targetDuration":4,"studyType":22,"phases":261,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":264,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":268,"locationsCount":269},"100448112","safety-and-performance-of-the-affera-spherepvi-multi-ablation-system-to-treat-paroxysmal-atrial-fibrillation-100448112","NCT05115214","Safety and Performance of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation","A Safety and Performance Assessment of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation","Inclusion Criteria:\n\n1. Symptomatic paroxysmal or persistent atrial fibrillation (PAF) documented by:\n\n   * A physician's note indicating recurrent AF\n   * At least two electrocardiographically documented AF episodes within 12 months prior to enrollment\n2. Failure or intolerance of at least one Class I-IV anti-arrhythmic drug.\n3. Suitable candidate for catheter ablation.\n4. Age ≥ 18 and \\\u003C 75 years.\n5. Able and willing to give informed consent.\n6. Able and willing, and has ample means to comply with all pre-procedure, post-procedure and follow-up testing requirements.\n\nExclusion Criteria:\n\nSubjects will not be eligible for the study if any of the following criteria are met:\n\n1. Continuous AF lasting more than 12 months (long-standing persistent AF).\n2. AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or reversible or non-cardiac cause.\n3. Previous left atrial catheter or surgical ablation (including septal closure or left atrial appendage closure).\n4. Valvular cardiac surgical\u002Fpercutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).\n5. Any carotid stenting or endarterectomy.\n6. Any cardiac procedure (surgical or percutaneous) or percutaneous coronary intervention within 90 days prior to the initial procedure.\n7. Coronary artery bypass graft (CABG) procedure within the 6 months prior to the index ablation procedure.\n8. Awaiting cardiac transplantation or other cardiac surgery within 12 months following the initial ablation procedure.\n9. Presence of any type of implantable cardiac defibrillator (with or without biventricular pacing function).\n10. Documented thromboembolic event (stroke or transient ischemic attack) within the past 6 months (180 days).\n11. Documented left atrial thrombus on imaging.\n12. History of blood clotting or bleeding abnormalities.\n13. Any condition contraindicating chronic anticoagulation.\n14. Myocardial infarction (MI) within the 3 months (90 days) prior to the initial procedure.\n15. Body mass index \\>40 kg\u002Fm2.\n16. Left atrial diameter (anteroposterior) \\>50 mm for paroxysmal AF and \\>55mm for persistent AF.\n17. Diagnosed atrial myxoma.\n18. Left ventricular ejection fraction (EF) \\\u003C 40%.\n19. Uncontrolled heart failure or NYHA Class III or IV heart failure.\n20. Rheumatic heart disease.\n21. Hypertrophic cardiomyopathy.\n22. Unstable angina.\n23. Moderate to severe mitral valve stenosis.\n24. Severe mitral regurgitation (regurgitant volume ≥ 60 mL\u002Fbeat, regurgitant fraction ≥ 50%, and\u002For effective regurgitant orifice area ≥ 0.40cm2).\n25. Primary pulmonary hypertension.\n26. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.\n27. Renal failure requiring dialysis.\n28. Acute illness, active systemic infection, or sepsis.\n29. Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would impact the scientific soundness of the clinical trial results.\n30. Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence.\n31. Current or anticipated participation in any other clinical trial of a drug, device, or biologic during the duration of the study, unless pre-approved by the Sponsor.\n32. Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation.\n33. Known drug or alcohol dependency.\n34. Life expectancy less than 12 months.\n35. Vulnerable subject.",{"count":260,"type":21},150,[24],"A prospective, single-arm, multi-center study to evaluate the safety, performance, and effectiveness of the Affera SpherePVI™ Multi-Ablation System for treating paroxysmal atrial fibrillation.",[69],{"date":245,"type":43},{"date":266,"type":43},"2021-10-19",{"date":249,"type":21},{"name":49,"class":50},2,{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":277,"targetDuration":279,"studyType":89,"phases":4,"briefSummary":280,"conditions":281,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":290},"100518115","affera-global-registry-100518115","NCT06026345","Affera Global Registry","The Affera Global Registry is a Prospective, Global, Multi-center, Observational Post-market Registry (PMR)","Inclusion Criteria:\n\n* Subject is ≥ 18 years of age or minimum age as required by local regulations\n* Planned procedure using the commercially available Affera Platform\n* Willing and able to comply with study requirements and give IC (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements\n\nExclusion Criteria:\n\n* Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager\n* Subject with exclusion criteria required by local law",{"count":278,"type":21},540,"2 Years","The Affera Global Registry is a prospective, global, multi-center, observational post-market registry (PMR). The purpose of this study is to describe clinical performance and safety data in a broad patient population treated with the Affera Platform.",[69],"2025-10-02",{"date":284,"type":43},"2025-10-07",{"date":286,"type":43},"2023-12-22",{"date":288,"type":21},"2028-07-01",{"name":49,"class":50},12,""]