[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"atrial-arrhythmia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:atrial-arrhythmia":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,51,76,106,134,154,171,189,216,238,261,303],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100528802","convergent-ablation-plus-left-atrial-appendage-isolation-for-the-treatment-of-persistent-atrial-fibrillation-100528802",false,"NCT06165510","Convergent Ablation Plus Left Atrial Appendage Isolation for the Treatment of Persistent Atrial Fibrillation","CLIP-AF","Inclusion Criteria:\n\n* Age \\> 18 years; \\\u003C 80 years\n* Persistent AF \\> 1-year duration\n* Left atrium size \\\u003C 6cm\n* Pts should be able to provide written informed consent.\n\nExclusion Criteria:\n\n* Subjects currently enrolled in another investigational study except in case of observational registry with no associated treatments.\n* Subject has a reversible cause of AF or transient AF\n* Subject is absent of LAA or if the LAA is previously surgically ligated\n* Subject has had previous cardiac surgery or abdominal surgery.\n* Subject has contraindication to anticoagulation.\n* Patients with hypertrophic cardiomyopathy.\n* Patients with significant valve disease.\n* Subject has had previous catheter or surgical ablation",true,"ALL","18 Years","80 Years",{"count":21,"type":22},48,"ESTIMATED","INTERVENTIONAL",[25],"NA","A randomised controlled clinical trial to assess efficacy of convergent ablation with the LARIAT procedure, as compared to standard endocardial catheter ablation in patients with long-standing persistent atrial fibrillation (AF).",[28,29,30,31],"Persistent Atrial Fibrillation","Atrial Fibrillation, Persistent","Atrium; Fibrillation","Atrial Arrhythmia",[33,34,35,36,37],"Catheter ablation","Convergent procedure","Left atrial appendage","Hybrid ablation","Cardiac arrhythmias","RECRUITING","2026-06-24",{"date":41,"type":42},"2026-06-25","ACTUAL",{"date":44,"type":42},"2024-08-02",{"date":46,"type":22},"2026-11",{"name":48,"class":49},"Barts & The London NHS Trust","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100620137","a-study-on-the-acquisition-of-2d-ice-images-with-the-chorus-idx-system-in-subjects-undergoing-an-ablation-procedure-100620137","NCT07353710","A Study on the Acquisition of 2D ICE Images With the CHORUS IDx System in Subjects Undergoing an Ablation Procedure","SONAR-ICE","Inclusion Criteria:\n\n1. Subjects who are able and willing to provide written informed consent prior to any study procedure.\n2. Subjects who are planned for an ablation procedure for any atrial arrhythmia using any commercially available Boston Scientific Ablation System, per physician's judgement and hospitals' standard practice.\n3. Subjects who are willing and able to participate in all testing and assessments associated with this clinical study at an approved clinical investigation center.\n4. Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.\n\nExclusion Criteria:\n\n1. Any of the following cardiac implanted devices\n\n   * Any prosthetic mitral or tricuspid heart valve, such as ring, repairs or clips\n   * Atrial septal defect (ASD) occluders including interatrial baffle, closure device, patch, or patent foramen ovale or ASD occluder\n2. Subjects with contraindications related to the use of the CHORUS IDx™ System:\n\n   * Subjects with inadequate vascular access\n   * Subjects with active systemic infection\n   * Subjects with presence of a known intracardiac thrombus in the chamber of use\n3. Women who are confirmed to be pregnant or lactating at the time of the Index Procedure\n4. Presence of other medical conditions, that, in the investigator's opinion, could limit the subject's ability to participate in the study\n5. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the Sponsor to determine eligibility",{"count":59,"type":22},200,[25],"A first-in-human prospective data collection study including subjects who are planned to undergo an ablation procedure for any atrial arrhythmia as per medical judgement and the site's standard practice, represents the most viable means to collect human anatomy ICE images for the purpose of software development.",[31,63],"Intracardiac Echocardiography","NOT_YET_RECRUITING","2026-06-22",{"date":67,"type":42},"2026-06-23",{"date":69,"type":22},"2026-07-01",{"date":71,"type":22},"2027-01-31",{"name":73,"class":74},"Boston Scientific Corporation","INDUSTRY",8,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100641807","volta-medical-ai-software-in-real-world-during-af-ablation-100641807","NCT07621055","VOLta Medical AI-software in REal-World During AF Ablation","Real-World Experience of Volta Medical AI-software During AF Ablation Using Next-generation Mapping and Ablation Technologies","VOLTAIRE-AF","Inclusion Criteria:\n\n1. Patient aged 18 years or older.\n2. Patient candidate for catheter ablation to treat paroxysmal or persistent atrial fibrillation, atrial tachycardia, de novo or after one or several previous ablation procedures, and for which the investigator considers using Volta AF-Xplorer II.\n3. Patient able and willing to provide written informed consent to participate in the study.\n4. Only for France: Patient affiliated to the French social security system.\n\nExclusion Criteria:\n\n1. Contraindication to AF\u002FAT catheter ablation using RF and\u002For PFA.\n2. Patient who is or could potentially be pregnant.\n3. Person deprived of liberty or under guardianship.\n4. Person unable to undergo a medical monitoring for geographical, social or psychological reasons.\n5. Patient's refusal to participate in the study.\n6. Enrollment in a premarket clinical study evaluating device, drug or biologic product.",{"count":85,"type":22},150,"OBSERVATIONAL","This PMCF study \"VOLTAIRE-AF\" will allow to observe acute and long-term safety and performance outcomes of the last generation of Volta Medical AI software (Volta AF-Xplorer II) during AF ablation using next-generation mapping and ablation technologies over a 24-month follow-up and in \"real life\"clinical practice, without any imposed clinical workflow.",[89,31,90],"Atrial Fibrillation","Arrhythmias, Cardiac",[92,93,94,95,96,97,31],"Volta AF-Xplorer II","Artificial Intelligence","Cardiac ablation","Medical Device","Software","Volta Medical","2026-06-17",{"date":65,"type":42},{"date":101,"type":42},"2026-06-16",{"date":103,"type":22},"2030-06",{"name":97,"class":74},3,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":105},"100440400","baseline-atrial-fibrosis-predicts-risk-for-post-operative-atrial-fibrillation-in-patients-undergoing-cardiac-surgery-100440400","NCT05014802","Baseline Atrial Fibrosis Predicts Risk for Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery","Baseline Atrial Fibrosis Predicts Risk for Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery: A Pilot Study for SAPPORO-AF","Inclusion Criteria:\n\n* Male or female patients age 40 years of age or older\n* Patients with no history of atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) scheduled to undergo cardiac surgery (These surgeries include but are not limited to coronary artery bypass graft (CABG), valvular repair\u002Freconstruction, aneurysm repair, and insertion of pacemaker).\n\nExclusion Criteria:\n\n* Patients with a history of atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia)\n* Patients with a history of cardiac or open chest surgery\n* Patients with a history of catheter ablation\n* Patients under the age of 40\n* Patients with left ventricular assist device (LVAD) or scheduled to have LVAD implanted\n* Patients who have previously undergone extracorporeal membrane oxygenation (ECMO)\n* Patients who have undergone or will undergo heart transplantation\n* Patients with any health related Late Gadolinium Enhancement (LGE)-MRI contraindications (including previous allergic reaction to gadolinium, pacemakers, defibrillators, other devices\u002Fimplants contraindicated for MRI)\n* Acute or chronic severe renal disease with a low glomerular filtration rate (GFR), \\\u003C30 mL per minute per 1.73 m2 will be excluded from the trial. (A creatinine measurement should be available within the last 6 months. If not, a creatinine blood test will be drawn to assess for renal function before the MRI acquisition).\n* Patients weighing \\> 300 lbs. (MRI image quality decreases due to increased body mass index)\n* Patients currently pregnant or breastfeeding, or plan to become pregnant during the study period\n* Patients with cognitive impairment preventing them from giving informed consent will be excluded from the study\n* Patients who cannot read, speak, and\u002For understand English","40 Years","120 Years",{"count":116,"type":22},50,"The study aims to evaluate and compare the incidence of atrial arrhythmias (including Post-Operative Atrial Fibrillation (POAF), atrial flutter, and atrial tachycardia) stratified by baseline Utah fibrosis stages and overall fibrosis (%) of the left atrial wall area. The investigators hypothesize that patients with a higher baseline Utah fibrosis staging will experience a higher incidence of POAF.\n\nThe study also aims to evaluate and compare the in-hospital mortality, length-of-stay (LOS), complication rates (strokes, pneumonia, respiratory failure etc.) of the different Utah fibrosis stage cohorts. Perform cost analysis and compare between patients with POAF and patients without POAF. The investigators hypothesize that patients experiencing POAF will have a higher mortality rate, longer LOS, greater complications, and therefore, additional hospital costs.",[89,31,119,120],"Atrial Flutter","Atrial Tachycardia",[122,123,124],"Atrial Fibrosis","Cardiac Magnetic Resonance Imaging","Cardiac surgery","2026-06-11",{"date":127,"type":42},"2026-06-15",{"date":129,"type":42},"2021-11-21",{"date":131,"type":22},"2026-12",{"name":133,"class":49},"Tulane University",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":23,"phases":142,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":50},"100613795","feasibility-study-on-the-verafeye-imaging-and-navigation-system-for-guided-catheter-ablation-procedures-100613795","NCT07271238","Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures","INSiGHT","Inclusion Criteria:\n\n* IC1: Subject is at least 18 years of age at the time of consent\n* IC2: Subject is scheduled to undergo a standard of care catheter-ablation procedure to treat AFL\u002FAF, according to current international and local guidelines and per physician discretion\n* IC3: Subject is able to understand and willing to provide written informed consent\n* IC4: Subject is able and willing to complete all study assessments associated with this clinical study at an approved clinical study site\n\nExclusion Criteria:\n\n* EC1: Subject where placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion\n* EC2: Pregnant women or women who plan to become pregnant during the course of their participation in the study (women should either be of non- childbearing potential at the time of enrolment (as documented in the medical file) or have a negative pregnancy test within the previous 7 days prior to the procedure)\n* EC3: Subject implanted with an active cardiac rhythm management device (e.g. pacemaker, CRT, ICD)\n* EC4: Unrecovered\u002Funresolved Adverse Events from any previous invasive procedure\n* EC5: Any planned surgical or endovascular intervention within 30 days before or after the ablation procedure\n* EC6: Life expectancy less than 12 months\n* EC7: Current LA thrombus Note: Screening for LA thrombus is required to be performed within 48 hours prior to or during the index procedure. Method of screening per physician discretion. If an atrial thrombus is observed prior to or during the planned index procedure, the index procedure will not begin or will be terminated before accessing the left atrium, and no ablation will be performed. The index procedure for this subject may be rescheduled to be performed within 30 days post ICF signature, provided that the thrombus is no longer present.\n* EC8: Subjects who are currently enrolled in another study",{"count":116,"type":22},[25],"The objective of the study is to collect data on the usability and integration of the VERAFEYE Imaging and Guidance System in adult patients indicated to undergo a standard of care catheter-based ablation procedure for the treatment of Atrial Flutter (AFL), paroxysmal AF (PAF) or persistent AF (perAF).\n\nResults from this study may be used to guide development and refinement the VERAFEYE Imaging and Guidance System capabilities.",[89,119,31],"2026-06-09",{"date":147,"type":42},"2026-06-10",{"date":149,"type":42},"2026-03-03",{"date":151,"type":22},"2026-10-15",{"name":153,"class":74},"LUMA Vision Ltd.",{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":23,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":50},"100609099","anatomical-navigation-for-guided-electrophysiology-in-afl-and-afib-100609099","NCT07210151","Anatomical Navigation for Guided Electrophysiology in AFL and AFib","ANGEL-AF","Inclusion Criteria:\n\n* IC1: Subject is at least 18 years of age at the time of consent\n* IC2: Subject is scheduled to undergo a catheter-ablation procedure to treat AFL\u002FAF (\\*according to current international and local guidelines and per physician discretion)\n* IC3: Subject is able to understand and willing to provide written informed consent\n* IC4: Subject is able and willing to complete all study assessments associated with this clinical study at an approved clinical study site\n\nExclusion Criteria:\n\n* EC1: Subject where placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion\n* EC2: Pregnant women or women who plan to become pregnant during the course of their participation in the study (women should either be of non- childbearing potential at the time of enrolment (as documented in the medical file) or have a negative pregnancy test within the previous 7 days prior to the procedure)\n* EC3: Unrecovered\u002Funresolved Adverse Events from any previous invasive procedure\n* EC4: Any planned surgical or endovascular intervention within 30 days before or after the ablation procedure.\n* EC5: Life expectancy less than 12 months\n* EC6: Current LA thrombus\n\nNote: Screening for LA thrombus is required to be performed within 48 hours prior to or during the index procedure. Method of screening per physician discretion. If an atrial thrombus is observed prior to or during the planned index procedure, the index procedure will not begin or will be terminated before accessing the left atrium, and no ablation will be performed. The index procedure for this subject may be rescheduled to be performed within 30 days post ICF signature, provided that the thrombus is no longer present.",{"count":116,"type":22},[25],"The objective of the study is to collect data on the use of the VERAFEYE Anatomical Guidance System in adult patients indicated to undergo a catheter ablation procedure for the treatment of Atrial Flutter (AFL), paroxysmal AF (PAF) or persistent AF (perAF).\n\nThe study will collect specific information on management of AFL\u002FAF ablation procedures with the commercial VERAFEYE Anatomical Guidance System including but not limited to acute procedural success , and how the VERAFEYE Anatomical Guidance System is used overall. Results from this study may be used to guide development and refinement the VERAFEYE Anatomical Guidance System.",[89,119,31],{"date":147,"type":42},{"date":167,"type":42},"2026-01-29",{"date":169,"type":22},"2026-11-01",{"name":153,"class":74},{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":183,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":4},"100538637","registry-on-luma-visions-verafeye-system-enlight-100538637","NCT06293430","Registry on Luma Vision's VERAFEYE System (ENLIgHT)","Registry on Luma Vision's VERAFEYE System in Catheter Ablation and Left Atrial Appendage Closure Procedures","ENLIgHT","Key Inclusion Criteria:\n\n* Subject is 18 years of age or of legal age to give informed consent specific to state and national law at the time of consent\n* Subjects is indicated for an atrial fibrillation ablation and\u002For a left atrial appendage closure procedure with the VERAFEYE System as navigation and imaging system, per physician discretion;\n* Subject is able to understand and willing to provide written informed consent\n* Subject is able and willing to complete all study assessments at an approved clinical investigational center\n\nKey Exclusion Criteria:\n\n* Subjects who have undergone a previous cardiac ablation for the treatment of PAF\u002FLAA Closure\n* Subject where placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion\n* Pregnant women or women who plan to become pregnant during the course of their participation in the study (women should either be of non- childbearing potential at the time of enrolment (as documented in the medical file) or have a negative pregnancy test within the previous 7 days prior to the procedure)\n* Unrecovered\u002Funresolved Adverse Events from any previous invasive procedure\n* Subjects who are currently enrolled in another study (except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments)",{"count":116,"type":22},"The objective of the study is to compile real-world data on the use of the VERAFEYE System in standard of care atrial fibrillation (AF) ablation procedures and left atrial appendage closure (LAAC) procedures.",[89,182,31],"Left Atrial Appendage Closure",{"date":147,"type":42},{"date":185,"type":22},"2027-01-15",{"date":187,"type":22},"2027-09-15",{"name":153,"class":74},{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":23,"phases":198,"briefSummary":199,"conditions":200,"keywords":202,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":215},"100606902","balloon-based-pfa-ablation-post-approval-outcomes-for-paf-and-persaf-100606902","NCT07181590","BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF","BLAST-OFF","Inclusion Criteria:\n\n1. Documented symptomatic PAF or PersAF. Documentation requirements are as follows:\n\n   Paroxysmal:\n   * Physician's note indicating recurrent self-terminating AF AND\n   * One electrocardiographically documented PAF episode within 12 months prior to enrollment.\n\n   Persistent: Continuous AF sustained beyond 7 days and less than 1 year that is documented by\n   * Physician's note, AND either\n   * 24-hour Holter within 360 days prior to enrollment, showing continuous AF, OR\n   * Two electrocardiograms (from any form of rhythm monitoring) showing continuous AF:\n\n     * That are taken at least 7 days apart but less than 12 months apart\n     * If electrograms are more than 12 months apart, there must be one or more Sinus Rhythm recordings in between or within 12 months prior to consent\u002Fenrollment\n     * The most recent electrocardiogram must be within 180 days of enrollment.\n\n   NOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of AF from another ECG device.\n2. Plans to undergo a de novo ablation procedure with the Volt PFA Catheter due to symptomatic PAF or PersAF and is refractory, intolerant, or contraindicated to at least one Class I-IV AAD medication\n3. At least 18 years of age\n4. Able and willing to comply with all trial requirements including pre-procedure, post- procedure, and follow-up testing and requirements\n5. Informed of the nature of the trial, agreed to its provisions, and has provided written informed consent as approved by the Institutional Review Board\u002FEthics Committee (IRB\u002FEC) of the respective clinical trial site.\n\nExclusion Criteria\n\n1. Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures in the preceding 90 days\n2. Known presence of cardiac thrombus\n3. Known Left ventricular ejection fraction \\\u003C 35% as assessed with echocardiography within 360 days of index procedure\n4. New York Heart Association (NYHA) class III or IV heart failure\n5. Pregnant, nursing, or planning to become pregnant during the clinical investigation follow-up period\n6. Patients who have had a ventriculotomy or atriotomy within the preceding 30 days of procedure\n7. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 90 days\n8. Unstable angina\n9. Stroke or TIA (transient ischemic attack) within the last 90 days\n10. Heart disease in which corrective surgery is anticipated within 180 days after procedure\n11. History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti-coagulant state\n12. Contraindication to long term anti-thromboembolic therapy\n13. Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation\n14. Previous left atrial surgical or left atrial catheter ablation procedure (including LAA closure device)\n15. Severe mitral regurgitation (regurgitant volume ≥ 60 mL\u002Fbeat, regurgitant fraction ≥ 50%, and\u002For effective regurgitant orifice area ≥ 0.40cm2).\n16. Previous tricuspid or mitral valve replacement or repair\n17. Patients with prosthetic valves\n18. Patients with a myxoma\n19. Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt\n20. Stent, constriction, or stenosis in a pulmonary vein\n21. Rheumatic heart disease\n22. Hypertrophic cardiomyopathy\n23. Diagnosed with amyloidosis or atrial amyloidosis\n24. Active systemic infection\n25. Renal failure requiring dialysis\n26. Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms\n27. Presence of an implanted LAA closure device\n28. Patient is currently participating in another clinical study that may confound the results of this of this post market evaluation; for example, enrolled in another study with an active treatment arm\n29. Unlikely to survive the protocol follow up period of 12 months\n30. Presence of other medical, anatomic, comorbid, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.\n31. Individuals without legal authority\n32. Individuals unable to read or write",{"count":197,"type":22},300,[25],"This study is designed to obtain real-world clinical evidence on the safety and effectiveness of the Volt PFA System in various use cases, with a sub study designed to address additional clinical evidence needs in electrophysiology.",[201,31,89,28],"Paroxysmal AF",[203,28,204,205],"Paroxysmal Atrial Fibrillation","Pulsed Field Ablation","Persistent Field Ablation","2026-05-21",{"date":208,"type":42},"2026-05-26",{"date":210,"type":42},"2025-12-11",{"date":212,"type":22},"2027-08",{"name":214,"class":74},"Abbott Medical Devices",22,{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":237},"100301859","atrial-tachycardia-pacing-therapy-in-congenital-heart-100301859","NCT03209583","ATrial Tachycardia PAcing Therapy in Congenital Heart","AT-PATCH","Inclusion Criteria:\n\n* must have structural CHD, an atrial arrhythmia and an ATD implanted. ATP must be turned on.\n\nExclusion Criteria:\n\n* Other arrhythmias substrates such as Long QT (LQT), hypertrophic Cardiomyopathy (HCM), Catecholaminergic polymorphic ventricular tachycardia (CPVT), Arrhythmogenic Right Ventricular Cardiomyopathy.(ARVC), Brugada \\& patients who undergo transplant, surgical maze, or ablation within 5 years of ATD implantation.",{"count":197,"type":22},"Congenital heart disease (CHD) affects approximately 1% of newborns in the US, with 25% of those affected having critical conditions requiring open heart surgery within one year of birth. Surgical and medical advances have allowed many patients to live beyond their fourth and fifth decades of life. Unfortunately, cardiac arrhythmias are a relatively common sequela due to cardiac anomalies and surgical scars in addition to residual volume and pressure load on the heart. Atrial arrhythmias, including sinus node dysfunction and intra-atrial re-entrant tachycardia (IART) are among the more common abnormalities found in adults with repaired CHD. The presence of IART significantly increases morbidity and mortality, and anti-arrhythmic medications have been shown to be a sub-optimal treatment strategy with the majority of patients requiring multi-drug therapy. Catheter ablation procedures remain a treatment option, but are less successful for some patient demographics. In the mid-1990's, pacemakers with atrial anti-tachycardia pacing (ATP) capabilities were developed, primarily for the management of atrial flutter and fibrillation in adults with structurally normal hearts. Given the need for pacemakers in the CHD population to manage sinus node dysfunction and atrioventricular node conduction block, the adoption of atrial anti-tachycardia pacemakers began to gain favor. However, there is limited data available comparing the safety and effectiveness of ATP therapy between various demographics of CHD patients. In the current study, the investigators aim to determine if ATP is an effective treatment strategy for IART, specifically within particular sub-populations of CHD patients. Additionally, investigators hope to delineate any significant differences in efficacy of ATP treatment between adult and pediatric congenital heart patients. The research team will accomplish our goals with a retrospective, multi-center study in which data is collected from existing electronic medical records and pacemaker interrogations. Following data collection, the investigators will employ statistical analyses to determine if certain CHD demographics are statistically significant predictors of ATP therapy outcomes.\n\nThe purpose of this prospective\u002Fretrospective study is to determine how effective atrial anti-tachycardia therapies are with the congenital heart patients who are known to have atrial arrhythmias. As this population ages, we know that arrhythmic burden increases and medications are increased or changed for symptomatic improvement.\n\nPatients will be enrolled at the time of anti tachycardia device (ATD) placement or when device therapies are turned on. Patients will need a minimum of 5 years of clinical history prior to implantation and after implantation (unless patient is very young). Data will be collected both retrospectively and prospectively. The research team will consent patients at the time of clinical evaluations and scheduled follow-ups (usually 3 - 6 months). If therapy is effective, investigators will determine the specific programming which was successful. If therapy was ineffective, investigators will also determine if a change in programing was made and if this improved ATP efficacy. Investigators will also determine the arrhythmia burden. Cardioversion and medications before and after ATD implantation will be the key determinants of arrhythmia burden in this study.",[31,120,226,227],"Congenital Heart Disease","Pacemaker Re-Entrant Tachycardia","2026-03-11",{"date":230,"type":42},"2026-03-13",{"date":232,"type":42},"2018-09-01",{"date":234,"type":22},"2027-09-01",{"name":236,"class":49},"Ian Law",15,{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":23,"phases":248,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":260},"100625925","av-node-ablation-and-conduction-system-pacing-for-atrial-fibrillation-with-preserved-left-ventricular-function-100625925","NCT07428967","AV Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function","AtrioVentricular Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function - a Randomized Controlled Trial","AVA CONDUCT","Inclusion Criteria:\n\n1. History of symptomatic AF (EHRA IIb - IV) despite guideline-indicated medical or interventional therapy\n2. Preserved LVEF (≥ 50%, assessed by echocardiography, Simpson's biplane method)\n3. AV node ablation scheduled independently of possible study participation\n4. Age ≥ 18 years\n5. Consent capacity\n\nExclusion Criteria:\n\n1. Impaired LVEF (\\\u003C 50%)\n2. Pre-implanted pacemaker\n3. Contraindication for pacemaker implantation or AV node ablation (see chapter 5.3 for details)\n4. High grade (III°) left cardiac valvular disease\n5. Surgical coronary revascularization (within the last 30 days) or current triple therapy after stent PCI\n6. Body-mass-index \\> 40 kg\u002Fm2\n7. Pregnancy\n8. Inability to give written informed consent\n9. Life expectancy \\\u003C 12 months",{"count":247,"type":22},86,[25],"AVA CONDUCT is a prospective, multicenter, randomized study with single blinding, comparing left bundle branch area (LBBA) pacing with right ventricular (RV) pacing following AV node ablation in terms of clinical, functional, and electrophysiological outcomes.\n\nThe primary hypothesis is that pacing-induced cardiomyopathy, defined as a decrease in LVEF by 10% or more from baseline to an absolute value below 50%, occurs significantly more frequently in patients receiving RV pacing compared with LBBA pacing. Secondarily, LBBA pacing is expected to maintain comparable procedural safety while providing better cardiac function, resulting in improved quality of life and functional capacity compared with conventional RV pacing.",[89,31],"2026-02-17",{"date":253,"type":42},"2026-02-24",{"date":255,"type":42},"2026-02-01",{"date":257,"type":22},"2029-12-31",{"name":259,"class":49},"St. Josefs-Hospital Wiesbaden GmbH",2,{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":269,"targetDuration":271,"studyType":86,"phases":4,"briefSummary":272,"conditions":273,"keywords":278,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":50},"100616406","study-of-ahre-burden-in-patients-undergoing-bachmann-bundle-area-pacing-and-left-bundle-branch-pacing-100616406","NCT07305194","Study of AHRE Burden in Patients Undergoing Bachmann Bundle Area Pacing and Left Bundle Branch Pacing.","Study of Atrial High-Rate Episode Burden in Patients Undergoing Concurrent Bachmann Bundle Area Pacing and Left Bundle Branch Pacing , Compared With Either Left Bundle Branch Pacing or Conventional Right Ventricular Pacing.","AHRE-BLAST","Inclusion Criteria:\n\n* Adult patients (≥ 18 years) with a clear indication for permanent pacing, according to ESC guidelines \\[15\\] for the management of conduction disturbances (e.g. symptomatic bradycardia, complete atrioventricular block, sinus node dysfunction).\n* Sinus rhythm at the time of implantation, with no documented episodes of atrial fibrillation prior to implantation, either in the medical history or in previous recordings (ECG, Holter, telemetry).\n* Ability to be followed up for at least 24 months after implantation.\n* Provision of written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* History of atrial fibrillation prior to implantation, either permanent or paroxysmal, documented on ECG, Holter, or telemetry.\n* Prior pharmacological or interventional treatment for AF (e.g. antiarrhythmic drugs, catheter ablation).\n* Inability to comply with long-term follow-up or non-adherence to follow-up visits.\n* Contraindications to pacemaker lead placement at the selected sites.\n* Participation in another study that could influence the results.\n* Previous device implantation.",{"count":270,"type":22},460,"24 Months","This prospective observational study evaluates the burden of Atrial High-Rate Episodes (AHRE) in patients without a prior history of atrial fibrillation who undergo concurrent Bachmann Bundle Area Pacing (BBAP) and Left Bundle Branch Pacing (LBBP). Physiological pacing at these sites aims to improve interatrial conduction and reduce the risk of atrial arrhythmias.\n\nThe study includes a comparative assessment across three patient groups:\n\n1. BBAP + LBBP (physiological pacing group)\n2. Right Atrial Appendage (RAA) pacing + LBBP\n3. Conventional pacing - RAA and Right Ventricular (RV) pacing AHRE burden will be quantified via device diagnostics and remote monitoring at 3, 12 and 24 months post-implantation. Episodes will be classified by duration (0-6 min, 6-24 h, \\>24 h), differentiating subclinical AHRE from clinically documented AF.\n\nSecondary analyses include electrocardiographic changes (P-wave indices), the need for antiarrhythmic therapy, and comprehensive echocardiographic evaluation of atrial function (e.g., LA strain, conduction delays, LAVI).\n\nThe study aims to determine whether physiological pacing (BBAP + LBBP) provides superior protection against AHRE development compared with RAA + LBBP and conventional pacing strategies.",[31,274,275,276,277],"Atrial Fibrillation (AF)","Pacemaker Implantation","Left Bundle Branch Pacing","Conduction System Pacing",[279,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294],"Atrial High-Rate Episodes (AHRE)","Subclinical Atrial Fibrillation","Bachmann Bundle Area Pacing (BBAP)","Left Bundle Branch Pacing (LBBP)","Physiological Pacing","Interatrial Conduction","Atrial Synchrony","P-wave Duration","Atrial Electromechanical Remodeling","Atrial Strain","Left Atrial Reservoir Strain","Inter-atrial Conduction Delay (IACD)","Speckle Tracking Echocardiography","Left Atrial Volume Index (LAVI)","Atrial Arrhythmias","Device-Detected AF",{"date":296,"type":42},"2025-12-26",{"date":298,"type":22},"2026-01-01",{"date":300,"type":22},"2028-04-14",{"name":302,"class":49},"University Hospital of Patras",{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":23,"phases":313,"briefSummary":314,"conditions":315,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":327},"100470880","hybrid-ablation-of-atrial-fibrillation-in-heart-failure-100470880","NCT05411614","Hybrid Ablation of Atrial Fibrillation in Heart Failure","A Randomised Controlled Trial Comparing Convergent Hybrid Ablation to Catheter Ablation in Patients With Persistent Atrial Fibrillation and Heart Failure","HALT AF","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Persistent or Long-standing Persistent AF\n* Dilated left atrium (at least moderately dilated)\n* Suitable for either procedure\n* LVEF \\\u003C 50%\n\nExclusion Criteria:\n\n* Not yet optimised from a medical or lifestyle perspective for AF or heart failure\n* Unable to provide written consent\n* Previous open-heart surgery\n* Active infection, oesophageal ulcer stricture or oesophageal varices\n* Prior catheter ablation of atrial fibrillation (prior ablation for atrial flutter \u002F supraventricular tachycardia or ventricular arrhythmia acceptable)\n* Contraindication to anticoagulation, or active thrombus in the left atrium despite therapeutic anticoagulation\n* Severe valvular heart disease\n* Unstable coronary artery disease\n* Uncontrolled ventricular arrhythmia\n* Heart attack or stroke within the last 90 days\n* Pregnant, breastfeeding, or women of childbearing age who plan to get pregnant within six months\n* Severe concomitant condition or presence of an implanted device that would preclude the patient from undergoing trial procedures",{"count":312,"type":22},120,[25],"A randomised controlled trial to assess the efficacy of staged hybrid ablation when compared with standard catheter ablation in patients with non-paroxysmal atrial fibrillation (AF) and Heart Failure",[28,29,31,89,316,317],"Heart Failure","Left Ventricular (LV) Systolic Dysfunction","2025-11-23",{"date":320,"type":42},"2025-11-28",{"date":322,"type":42},"2022-06-25",{"date":324,"type":22},"2027-10",{"name":326,"class":49},"St. George's Hospital, London",7]