[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Biosense Webster, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":212},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,42,65,87,104,124,145,158,180],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100054199","a-study-of-varipulse-catheter-and-trupulse-generator-with-varipulse-pro-software-in-participants-with-paf-or-psaf-100054199",false,"NCT07429214","A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF","Workflow Study of the VARIPULSE™ Catheter With the TRUPULSE™ Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF) or Persistent Atrial Fibrillation (PsAF) With the New VARIPULSE™ Pro Software","VP-CONFIRM","Inclusion criteria:\n\n* Diagnosed with symptomatic persistent atrial fibrillation (PsAF) or paroxysmal atrial fibrillation (PAF)\n* Selected to undergo an ablation procedure for management of their arrhythmia by pulmonary vein isolation (PVI) only or PVI only with cavotricuspid isthmus (CTI) dependent atrial flutter ablation\n* Failed at least one antiarrhythmic drug (AAD; class I to IV) as evidenced by recurrent symptomatic atrial fibrillation (AF), or intolerable or contraindicated to the AAD\n* Age 18-75 years\n* Willing and capable of providing consent\n* Able and willing to comply with all pre-, post- and follow-up testing and requirements\n\nExclusion criteria:\n\n* Continuous AF greater than (\\>) 12 months (1-Year) (Longstanding Persistent AF)\n* Previous surgical or catheter ablation for atrial fibrillation\n* Any cardiac surgery within the past 2 months (60 days prior to consent date) (includes percutaneous coronary intervention \\[PCI\\])\n* Previous coronary artery bypass grafting (CABG) in conjunction with valvular surgery, cardiac surgery (for example, ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure\n* Any carotid stenting or endarterectomy\n* Presence of left atrium (LA) thrombus\n* Severe dilatation of the LA (left atrial diameter \\[LAD\\] \\>50 millimeters \\[mm\\] antero-posterior diameter in case of transthoracic echocardiography \\[TTE\\])\n* Severely compromised left ventricular ejection fraction (LVEF less than \\[\\\u003C\\] 40 percent \\[%\\])\n* Known significant pulmonary vein (PV) anomaly that in the opinion of the investigator would preclude enrollment in this study\n* Prior diagnosis of pulmonary vein stenosis\n* Pre-existing hemi diaphragmatic paralysis\n* History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)\n* Myocardial infarction (MI) within the past 2 months (60 days prior to consent date)\n* Documented thromboembolic event (including transient ischemic attack \\[TIA\\]) within the past 6 months \\[180 days prior to consent date\\])\n* Rheumatic Heart Disease\n* Uncontrolled heart failure or New York heart association (NYHA) function class III or IV\n* Severe mitral regurgitation\n* Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months\n* Unstable angina pectoris within the past 6 months prior to consent date\n* Acute illness or active systemic infection or sepsis\n* Previously known AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, documented obstructive sleep apnea, acute alcohol toxicity, morbid obesity \\[Body Mass Index \\>40 kilogram per meter square {kg\u002Fm\\^2}\\], renal insufficiency (with an estimated creatinine clearance \\\u003C 30 milliliters per minute {mL\u002Fmin}\u002F1.73 m\\^2)\n* Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch, prosthetic valve or other abnormality that precludes catheter introduction or manipulation\n* Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter\n* Presence of any other condition that precludes appropriate vascular access (such as inferior vena cava \\[IVC\\] filter)\n* Significant pulmonary disease, (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease \\[COPD\\]) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms\n* Significant congenital anomaly or medical problems that in the opinion of the investigator would preclude enrollment in this study\n* Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation\n* Current enrollment in an investigational study evaluating another device, biologic, or drug\n* Presenting contra-indications for the devices used in the study, as indicated in the respective instructions for use (IFU)\n* Categorized as vulnerable population and requiring special treatment with respect to safeguards of well-being\n* Life expectancy less than 12 months\n* Contraindication for MRI such as use of contrast agents due to advanced renal disease, claustrophobia, implantable pacemakers, implantable cardioverter\u002Fdefibrillators (ICDs),etc. (at principal investigator \\[PI\\] discretion)\n* Presence of iron-containing metal fragments in the body\n* Unresolved pre-existing neurological deficit","ALL","18 Years","75 Years",{"count":21,"type":22},50,"ESTIMATED","INTERVENTIONAL",[25],"NA","The main purpose of this clinical study is to investigate the effectiveness workflow of the clinical use of the pulsed field (PF) ablation system (VARIPULSE™ Catheter and TRUPULSE™ Generator) when used for cardiac ablation with the new VARIPULSE™ Pro software in participants with paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and stop on their own, usually within seven days) and persistent atrial fibrillation (PsAF; irregular, rapid heartbeat that lasts over 7 days up to 1year and doesn't stop on its own).",[28],"Atrial Fibrillation","RECRUITING","2026-07-10",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":33},"2026-03-23",{"date":37,"type":22},"2026-12-30",{"name":39,"class":40},"Biosense Webster, Inc.","INDUSTRY",10,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100633485","a-study-of-varipulse-catheter-in-participants-with-persistent-atrial-fibrillation-undergoing-pulmonary-vein-and-superior-vena-cava-isolation-100633485","NCT07527299","A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior Vena Cava Isolation","Assessment of the Safety and Effectiveness of the VARIPULSE™ Catheter System in the Treatment of Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein (With or Without Posterior Wall Isolation) and Superior Vena Cava Isolation: A Randomized Controlled Trial","SPAA PFA","Inclusion criteria:\n\n* Participant has been diagnosed with symptomatic persistent atrial fibrillation (PsAF), which is defined as continuous atrial fibrillation (AF) sustained beyond 7 days in duration and less than 365 days in duration, documented by: i. A physician's note documenting diagnosis of symptomatic PsAF, as defined above; and ii. Two electrocardiograms (ECGs) showing continuous AF, with electrocardiogram taken at least 7 days apart (electrocardiograms cannot be greater than (\\>) 365 days prior to enrollment); or iii. A 24-hour arrhythmia monitor documenting continuous AF within the last 365 days\n* Participant is aged 18 - 80 years at the time of informed consent\n* Participant is willing and capable of providing informed consent\n* Participant is able and willing to comply with all pre-, post- and follow-up testing and requirement\n\nLeft atrial appendage occlusion (LAAO) concomitant subset:\n\n\\- Participant is clinically indicated for a LAAO procedure\n\nExclusion criteria:\n\n* Participant has continuous AF \\> 365 days (longstanding persistent AF)\n* Participant has AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, untreated documented obstructive sleep apnea, acute alcohol toxicity, etc.)\n* Participant has had previous surgical or catheter ablation for AF\n* Participant is known to require ablation outside the left atrium (LA), superior vena cava (SVC), and the cavotricuspid isthmus (CTI) region (for example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, ventricular tachycardia and Wolff-Parkinson-White)\n* Participant has severe dilatation of the LA (left atrial diameter \\[LAD\\] \\> 50 millimeters \\[mm\\]) of the antero-posterior diameter confirmed by imaging performed within 180 days prior to enrollment\n* Participant has LA thrombus confirmed by imaging within 48 hours prior to the procedure\n* Participant has severely compromised left ventricular ejection fraction (left ventricle ejection fraction \\[LVEF\\] less than \\[\\\u003C\\] 40 percent \\[%\\]) confirmed by imaging performed within 180 days prior to enrollment\n* Participant has uncontrolled heart failure or New York heart association (NYHA) Class III or IV functional classification\n* Participant has a history of blood clotting, bleeding abnormalities or contraindication to anticoagulation (for example, heparin)\n* Participant has had a thromboembolic event (including transient ischemic attack \\[TIA\\]) within the past 180 days prior to enrollment\n* Participant has had a percutaneous coronary intervention or acute myocardial infarction (MI) within past 60 days prior to enrollment\n* Participant has had coronary artery bypass grafting (CABG) surgery within the past 180 days prior to enrollment\n* Participant has had valvular cardiac surgical\u002Fpercutaneous procedure (that is, ventriculotomy, atriotomy, valve repair or replacement and presence of a prosthetic valve)\n* Participant has unstable angina within past 6 months prior to enrollment\n* Participant has anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 365 days post-procedure\n* Participant has significant pulmonary disease (for example, 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\n* Participant has a significant congenital anomaly (for example, atrial septal defects \\[ASDs\\]) including repaired defects or medical problems that in the opinion of the Investigator would preclude enrollment in this study\n* Participant has an existing diagnosis of pulmonary vein stenosis (PVS)\n* Participant has a pre-existing hemi-diaphragmatic paralysis\n* Participant has an acute illness, active systemic infection, or sepsis\n* Participant has an intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation\n* Participant has severe mitral regurgitation (Regurgitant volume greater than or equal to \\[\\>=\\] 60 milliliters \\[mL\\]\u002Fbeat, Regurgitant fraction \\>= 50%, and\u002For Effective regurgitant orifice area \\>= 0.40 square centimeter \\[cm\\^2\\])\n* Participant has an implanted metal cardiac device (other than coronary stents, implanted pacemaker, implantable cardioverter-defibrillator \\[ICD\\], implantable loop recorder \\[ILR\\]) that may interfere with the pulsed field (PF) energy field\n* Participant has a condition that precludes vascular access (such as inferior vena cava \\[IVC\\] filter) - Participant is currently enrolled in an investigational study evaluating another device or drug\n* Participant is pregnant, lactating, or is of child-bearing potential and plans on trying to become pregnant during the course of the clinical investigation\n* Participant has a life expectancy of less than 365 days\n* Participant has contraindications for the devices used in the study, as indicated in the respective instructions for use (IFUs)\n* Participant has contraindications for the ablation of the SVC\n\nLAAO concomitant subset:\n\n* Participant is contraindicated for a LAAO procedure per the instructions of use of the planned LAAO device\n* Participant with prior LAAO procedure (attempted or successful)","80 Years",{"count":52,"type":22},920,[25],"The purpose of this study is to assess how safe VARIPULSE catheter system is for treatment of a heart rhythm disease called persistent atrial fibrillation (PsAF) in participants who are having a catheter ablation procedure (treat heart rhythm disease). This includes isolation of pulmonary vein and superior vena cava (heart veins; PVI and SVCI), with or without another technique called posterior wall isolation (PWI). Also, to assess how safe it is for participants who are having a catheter ablation procedure and at the same time receiving another procedure called left atrial appendage occlusion (LAAO; to reduce stroke risk). Additionally, to assess how well VARIPULSE catheter system works over a long period of time for treatment of PsAF in participants undergoing catheter ablation.",[28],"2026-06-18",{"date":58,"type":33},"2026-06-22",{"date":60,"type":22},"2026-08-05",{"date":62,"type":22},"2031-08-04",{"name":39,"class":40},19,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":73,"targetDuration":4,"studyType":23,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},"100633212","a-study-of-varipulse-pulsed-field-ablation-pfa-catheter-and-farawave-pfa-catheter-in-the-treatment-of-participants-with-persistent-atrial-fibrillation-100633212","NCT07523750","A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation","Comparison of Safety and Effectiveness of a VARIPULSE™ PFA Catheter to FARAWAVE™ PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation: A Randomized Controlled Trial","PERSIGMA RCT","Inclusion criteria:\n\n* Participant has been diagnosed with symptomatic persistent atrial fibrillation (PsAF), which is defined as continuous atrial fibrillation (AF) sustained beyond 7 days and less than 365 days in duration documented by: i. A physician's note documenting diagnosis of symptomatic PsAF as defined above and ii. Two electrocardiograms showing continuous AF, with electrocardiogram taken at least 7 days apart (electrocardiograms cannot be greater than \\[\\>\\] 365 days prior to enrollment) or iii. A 24-hour arrhythmia monitor documenting continuous AF within the last 365 days\n* Participant is aged 18 - 80 years at the time of informed consent\n* Participant is willing and capable of providing informed consent\n* Participant is able and willing to comply with all pre-, post- and follow-up testing and requirements\n\nExclusion criteria:\n\n* Participant has continuous AF \\> 365 days (longstanding persistent AF)\n* Participant has AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, untreated documented obstructive sleep apnea, acute alcohol toxicity, etc.)\n* Participant has had previous surgical or catheter ablation for AF\n* Participant is known to require ablation outside the left atrium (LA), superior vena cava (SVC), and the cavotricuspid isthmus (CTI) region (for example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, ventricular tachycardia and Wolff-Parkinson-White)\n* Participant has severe dilatation of the LA (LAD \\> 50 millimeters \\[mm\\]) of the antero-posterior diameter confirmed by imaging performed within 180 days prior to enrollment\n* Participant has LA thrombus confirmed by imaging within 48 hours prior to the procedure\n* Participant has severely compromised Left Ventricular Ejection Fraction (LVEF less than \\[\\\u003C\\] 40%) confirmed by imaging performed within 180 days prior to enrollment\n* Participant has uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV\n* Participant has a history of blood clotting, bleeding abnormalities or contraindication to anticoagulation (for example, heparin)\n* Participant has had a thromboembolic event (including TIA) within the past 180 days prior to enrollment\n* Participant has had a percutaneous coronary intervention or acute MI within past 60 days prior to enrollment\n* Participant has had coronary artery bypass grafting (CABG) surgery within the past 180 days prior to enrollment\n* Participant has had valvular cardiac surgical\u002Fpercutaneous procedure (that is, ventriculotomy, atriotomy, valve repair or replacement and presence of a prosthetic valve)\n* Participant has unstable angina within past 6 months prior to enrollment\n* Participant has anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 365 days post-procedure\n* Participant has significant pulmonary disease (for example, 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\n* Participant has a significant congenital anomaly (for example, atrial septal defects \\[ASDs\\]) including repaired defects or medical problems that in the opinion of the Investigator would preclude enrollment in this study\n* Participant has an existing diagnosis of pulmonary vein stenosis (PVS)\n* Participant has a pre-existing hemi-diaphragmatic paralysis\n* Participant has an acute illness, active systemic infection, or sepsis\n* Participant has an intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation\n* Participant has severe mitral regurgitation (regurgitant volume greater than or equal to \\[\\>=\\] 60 milliliters \\[mL\\]\u002Fbeat, regurgitant fraction \\>= 50 percent \\[%\\], and\u002For effective regurgitant orifice area \\>= 0.40 square centimeter \\[cm\\^2\\])\n* Participant has an implanted metal cardiac device (other than coronary stents, implanted pacemaker, implantable cardioverter-defibrillator \\[ICD\\], implantable loop recorder \\[ILR\\]) that may interfere with the pulsed field (PF) energy field\n* Participant has a condition that precludes vascular access (such as inferior vena cava \\[IVC\\] filter)\n* Participant is currently enrolled in an investigational study evaluating another device or drug\n* Participant is pregnant, lactating, or is of child-bearing potential and plans on trying to become pregnant during the course of the clinical investigation\n* Participant has a life expectancy less than 365 days",{"count":74,"type":22},466,[25],"The purpose of this study is to assess how safe VARIPULSE pulsed field ablation (PFA) catheter is and how well it works compared to food and drug administration (FDA) approved FARAWAVE PFA catheter in participants with symptomatic persistent atrial fibrillation (PsAF; continuous irregular, rapid heartbeat that lasts over 7 days and doesn't stop on its own).",[28],"2026-06-04",{"date":80,"type":33},"2026-06-05",{"date":82,"type":33},"2026-04-02",{"date":84,"type":22},"2028-05-31",{"name":39,"class":40},11,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":103,"locationsCount":41},"100625894","a-study-of-varipulse-catheter-and-trupulse-generator-with-varipulse-pro-software-in-participants-with-psaf-100625894","NCT07428564","A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE PRO Software in Participants With PsAF","Workflow Study of the VARIPULSE™ Catheter With the TRUPULSE™ Generator for Treatment of Persistent Atrial Fibrillation (PsAF) With the New VARIPULSE™ Pro Software","VP-EXTRA","Inclusion criteria:\n\n* Diagnosed with symptomatic persistent atrial fibrillation (PsAF)\n* Selected to undergo an ablation procedure for management of their arrhythmia by pulmonary vein isolation (PVI) +\n* Failed at least one antiarrhythmic drug (AAD; class I to IV) as evidenced by recurrent symptomatic atrial fibrillation (AF), or intolerable or contraindicated to the AAD\n* Age 18-75 years\n* Willing and capable of providing consent\n* Able and willing to comply with all pre-, post- and follow-up testing and requirements\n\nExclusion criteria:\n\n* Continuous AF greater than (\\>) 12 months (1-Year) (Longstanding Persistent AF)\n* Previous surgical or catheter ablation for atrial fibrillation\n* Any cardiac surgery within the past 2 months (60 days prior to consent date) (includes percutaneous coronary intervention \\[PCI\\])\n* Previous coronary artery bypass grafting (CABG) in conjunction with valvular surgery, cardiac surgery (for example, ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure\n* Any carotid stenting or endarterectomy\n* Presence of left atrium (LA) thrombus\n* Severe dilatation of the LA (left atrial diameter (LAD) \\> 50 millimeter \\[mm\\] antero-posterior diameter in case of transthoracic echocardiography \\[TTE\\])\n* Severely compromised left ventricular ejection fraction (LVEF less than \\[\\\u003C\\] 40%)\n* Known significant pulmonary vein (PV) anomaly that in the opinion of the investigator would preclude enrollment in this study\n* Prior diagnosis of pulmonary vein stenosis\n* Pre-existing hemi diaphragmatic paralysis\n* History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)\n* MI within the past 2 months (60 days prior to consent date)\n* Documented thromboembolic event (including transient ischemic attack \\[TIA\\]) within the past 6 months (180 days prior to consent date)\n* Rheumatic Heart Disease\n* Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV\n* Severe mitral regurgitation\n* Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months\n* Unstable angina pectoris within the past 6 months prior to consent date\n* Acute illness or active systemic infection or sepsis\n* Previously known AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, documented obstructive sleep apnea, acute alcohol toxicity, morbid obesity (Body Mass Index \\>40 kilogram per meter squared \\[kg\u002Fm\\^2\\]), renal insufficiency (with an estimated creatinine clearance \\\u003C 30 mL\u002Fmin\u002F1.73 m\\^2)\n* Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch, prosthetic valve or other abnormality that precludes catheter introduction or manipulation\n* Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter\n* Presence of any other condition that precludes appropriate vascular access (such as Inferior Vena Cava \\[IVC\\] filter)\n* Significant pulmonary disease, (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease \\[COPD\\]) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms\n* Significant congenital anomaly or medical problems that in the opinion of the investigator would preclude enrollment in this study\n* Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation.\n* Current enrollment in an investigational study evaluating another device, biologic, or drug\n* Presenting contra-indications for the devices used in the study, as indicated in the respective instruction for use (IFU)\n* Categorized as vulnerable population and requiring special treatment with respect to safeguards of well-being\n* Life expectancy less than 12 months\n* Contraindication for MRI such as use of contrast agents due to advanced renal disease, claustrophobia etc. (at PI discretion)\n* Presence of iron-containing metal fragments in the body\n* Unresolved pre-existing neurological deficit",{"count":21,"type":22},[25],"The main purpose of this study is to investigate the workflow of the clinical use of the pulsed field (PF) ablation system (VARIPULSE catheter and TRUPULSE generator) when used for cardiac ablation with the new VARIPULSE Pro software in participants with persistent atrial fibrillation (PsAF; irregular, rapid heart rhythm that lasts over 7 days and doesn't stop on its own).",[28],{"date":80,"type":33},{"date":101,"type":33},"2026-05-19",{"date":37,"type":22},{"name":39,"class":40},{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":112,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":118,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":64},"100610434","a-study-assessing-long-term-safety-and-effectiveness-in-treatment-management-of-atrial-fibrillation-with-varipulse-catheter-system-100610434","NCT07227532","A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System","Assessment of Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the VARIPULSE™ Catheter System","AdmIREPAS","Inclusion Criteria:\n\n* Symptomatic paroxysmal Atrial Fibrillation (AF) who, in the opinion of the investigator, are candidates for catheter ablation for AF\n* Refractory (that is, ineffective, not tolerated, or not desired) or contraindicated to at least one Class I\u002FIII antiarrhythmic drugs (AAD)\n* Willing and capable of providing consent\n* Able and willing to comply with all pre-, post-, and follow-up testing and requirements\n\nExclusion Criteria:\n\n* Previously diagnosed with persistent or long-standing persistent AF (more than \\[\\>\\] 7 days in duration)\n* Previous surgical or catheter ablation for AF\n* Significant congenital anomaly or medical problem that in the opinion of the investigator would be a contraindication to catheter ablation for AF\n* Current enrollment in an investigational study evaluating another device or drug\n* Life expectancy less than 12 months\n* Any contraindications as defined in the Protocol","22 Years",{"count":114,"type":22},276,[25],"The purpose of this study is to evaluate the long-term safety and effectiveness of the FDA approved VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF).",[28],{"date":80,"type":33},{"date":120,"type":33},"2025-10-21",{"date":122,"type":22},"2030-12-31",{"name":39,"class":40},{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":138,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},"100420135","an-observational-post-marketing-study-using-commercially-approved-biosense-webster-bwi-medical-devices-for-the-treatment-of-participants-with-cardiac-arrhythmias-100420135","NCT04750798","An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias","An Observational Post-marketing Study for Evaluation of Ongoing Safety and Effectiveness of Catheter Mapping and Ablation Using Commercially Approved BWI Medical Devices for the Treatment of Patients With Cardiac Arrhythmias","SECURE","Inclusion criteria\n\n* Diagnosed with paroxysmal or persistent Atrial Fibrillation (AF) or supraventricular tachycardia (SVT) or ventricular tachycardia (VT) and scheduled to undergo an ablation procedure for management of their arrhythmia with a per-protocol defined BW therapeutic catheter\n* Able and willing to comply with all pre, post and follow-up testing and requirements as per hospital standard of care\n* Signed patient informed consent form (ICF) as applicable per local regulation\n\nExclusion criteria:\n\n* Currently participating in an interventional (drug, device, biologic) clinical trial\n* Life expectancy of less than 12-months\n* Presenting any contraindication for the use of BWI commercially approved medical devices, as indicated in the respective user manuals",{"count":133,"type":22},8000,"OBSERVATIONAL","The purpose of this study is to prospectively collect clinical data evaluating the ongoing safety and performance during routine-use standard cardiac arrhythmia mapping and\u002For ablation procedures while using commercial Biosense Webster Inc. (BWI) medical devices. Data generated from the study will be used to confirm safety and performance of BWI medical devices in the marketed phase and to expand the body of evidence on the use of these devices and techniques in treatment of cardiac arrhythmias.",[137],"Arrhythmias, Cardiac",{"date":80,"type":33},{"date":140,"type":33},"2021-02-22",{"date":142,"type":22},"2037-12-31",{"name":39,"class":40},40,{"id":146,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":148,"targetDuration":4,"studyType":23,"phases":149,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":156,"leadSponsor":157,"locationsCount":41},"100625944","Inclusion criteria:\n\n* Diagnosed with symptomatic persistent atrial fibrillation (PsAF) or paroxysmal atrial fibrillation (PAF)\n* Selected to undergo an ablation procedure for management of their arrhythmia by pulmonary vein isolation (PVI) only or PVI only with cavotricuspid isthmus (CTI) dependent atrial flutter ablation\n* Failed at least one antiarrhythmic drug (AAD; class I to IV) as evidenced by recurrent symptomatic atrial fibrillation (AF), or intolerable or contraindicated to the AAD\n* Age 18-75 years\n* Willing and capable of providing consent\n* Able and willing to comply with all pre-, post- and follow-up testing and requirements\n\nExclusion criteria:\n\n* Continuous AF greater than (\\>) 12 months (1-Year) (Longstanding Persistent AF)\n* Previous surgical or catheter ablation for atrial fibrillation\n* Any cardiac surgery within the past 2 months (60 days prior to consent date) (includes percutaneous coronary intervention \\[PCI\\])\n* Previous coronary artery bypass grafting (CABG) in conjunction with valvular surgery, cardiac surgery (for example, ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure\n* Any carotid stenting or endarterectomy\n* Presence of left atrium (LA) thrombus\n* Severe dilatation of the LA (left atrial diameter \\[LAD\\] \\>50 millimeters \\[mm\\] antero-posterior diameter in case of transthoracic echocardiography \\[TTE\\])\n* Severely compromised left ventricular ejection fraction (LVEF less than \\[\\\u003C\\] 40 percent \\[%\\])\n* Known significant pulmonary vein (PV) anomaly that in the opinion of the investigator would preclude enrollment in this study\n* Prior diagnosis of pulmonary vein stenosis\n* Pre-existing hemi diaphragmatic paralysis\n* History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)\n* Myocardial infarction (MI) within the past 2 months (60 days prior to consent date)\n* Documented thromboembolic event (including transient ischemic attack \\[TIA\\]) within the past 6 months \\[180 days prior to consent date\\])\n* Rheumatic Heart Disease\n* Uncontrolled heart failure or New York heart association (NYHA) function class III or IV\n* Severe mitral regurgitation\n* Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months\n* Unstable angina pectoris within the past 6 months prior to consent date\n* Acute illness or active systemic infection or sepsis\n* Previously known AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, documented obstructive sleep apnea, acute alcohol toxicity, morbid obesity \\[Body Mass Index \\>40 kilogram per meter square {kg\u002Fm\\^2}\\], renal insufficiency (with an estimated creatinine clearance \\\u003C 30 milliliters per minute {mL\u002Fmin}\u002F1.73 m\\^2)\n* Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch, prosthetic valve or other abnormality that precludes catheter introduction or manipulation\n* Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter\n* Presence of any other condition that precludes appropriate vascular access (such as inferior vena cava \\[IVC\\] filter)\n* Significant pulmonary disease, (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease \\[COPD\\]) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms\n* Significant congenital anomaly or medical problems that in the opinion of the investigator would preclude enrollment in this study\n* Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation\n* Current enrollment in an investigational study evaluating another device, biologic, or drug\n* Presenting contra-indications for the devices used in the study, as indicated in the respective instructions for use (IFU)\n* Categorized as vulnerable population and requiring special treatment with respect to safeguards of well-being\n* Life expectancy less than 12 months\n* Contraindication for MRI such as use of contrast agents due to advanced renal disease, claustrophobia etc. (at principal investigator \\[PI\\] discretion)\n* Presence of iron-containing metal fragments in the body\n* Unresolved pre-existing neurological deficit",{"count":21,"type":22},[25],"The main purpose of this study is to investigate the workflow of the clinical use of the pulsed field (PF) ablation system (VARIPULSE catheter and TRUPULSE generator) when used for cardiac ablation with the new VARIPULSE Pro software in participants with paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and stop on their own, usually within seven days, often resolving within 24-48 hours, though sometimes lasting up to a week) and persistent atrial fibrillation (PsAF; irregular, rapid heartbeat that lasts over 7 days and doesn't stop on its own).",[28],"2026-05-07",{"date":154,"type":33},"2026-05-11",{"date":35,"type":33},{"date":37,"type":22},{"name":39,"class":40},{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":166,"targetDuration":4,"studyType":23,"phases":168,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},"100551054","a-study-of-assessment-on-safety-and-effectiveness-of-bwi-pulsed-field-ablation-with-omnypulse-catheter-for-the-treatment-of-paroxysmal-atrial-fibrillation-paf-100551054","NCT06455098","A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)","Assessment of Safety and Effectiveness in Treatment Management of Paroxysmal Atrial Fibrillation With the BWI Pulsed Field Ablation System With OMNYPULSE™ Catheter","OMNY-AF","Inclusion Criteria:\n\n* Diagnosed with symptomatic paroxysmal AF with:\n\n  1. At least two symptomatic AF episodes within last six months from enrollment\n  2. At least one electrocardiographically documented AF episode within twelve months prior to enrollment\n* Failed at least one Class I or Class III antiarrhythmic drug\n* Willing and capable to provide consent\n* Able and willing to comply with all pre-, post- and follow-up testing and requirements\n\nExclusion Criteria:\n\n* Previously diagnosed with persistent AF (greater than \\[\\>\\] 7 days in duration)\n* AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.\n* Previous surgical or catheter ablation for AF\n* Patients known to require ablation outside the PV ostia and outside the CTI region.\n* Documented severe dilatation of the left atrium (LAD\\>50 mm) antero-posterior diameter on imaging within 6 months prior to enrollment\n* Documented left atrium (LA) thrombus by imaging within 48 hours of the procedure\n* Documented severely compromised left ventricular ejection fraction (LVEF \\\u003C40%) by imaging within 6 months prior to enrollment\n* Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV\n* History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)\n* Documented thromboembolic event (including transient ischemic attack or TIA) within the past 6 months\n* Previous Percutaneous Coronary Intervention (PCI)\u002F myocardial infarction \\[MI\\] within the past 2 months\n* Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months\n* Valvular cardiac surgical\u002Fpercutaneous procedure\n* Unstable angina within 6 months\n* Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months\n* Significant pulmonary disease or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms\n* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study\n* Prior diagnosis of pulmonary vein stenosis\n* Pre-existing hemi diaphragmatic paralysis\n* Acute illness, active systemic infection, or sepsis\n* Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation\n* Severe mitral regurgitation\n* Presence of an implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device (other than coronary stents) that may interfere with the PF energy field)\n* Presence of a condition that precludes vascular access\n* Current enrollment in an investigational study evaluating another device or drug\n* Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation\n* Life expectancy less than 12 months\n* Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions for Use (IFU)",{"count":167,"type":22},440,[25],"The purpose of this study is to demonstrate the safety and 12-month effectiveness of the BWI OMNYPULSE™ pulsed field ablation (PFA) platform for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF), an irregular heart rate that causes abnormal blood flow.",[28],"2026-03-12",{"date":173,"type":33},"2026-03-13",{"date":175,"type":33},"2024-06-28",{"date":177,"type":22},"2026-06-30",{"name":39,"class":40},46,{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":23,"phases":190,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":211},"100601901","a-study-assessing-arrhythmia-mapping-with-a-multi-electrode-mapping-catheter-100601901","NCT07116525","A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter","Clinical Evaluation of Arrhythmia Mapping With a Paddle-shaped, High-density, Multi-electrode Mapping Catheter","FEATHER","Inclusion Criteria:\n\n* Diagnosed with and candidate for clinically indicated catheter mapping and ablation procedure for the management of ventricular tachycardia, premature ventricular complex, atrial tachycardia or atrial fibrillation (participant having undergone a previous ablation procedure may be included)\n* At least one episode of the targeted arrhythmia (ventricular tachycardia, premature ventricular complex, atrial tachycardia or atrial fibrillation) must have been documented by electrocardiogram (ECG), Holter, loop recorder, telemetry, implanted device, or transtelephonic monitoring within 12 months prior to enrollment\n* Age 18 years or older\n* Signed Patient Informed Consent Form (ICF)\n* Able and willing to comply with all pre-, post-, and follow-up testing and requirements\n\nExclusion Criteria:\n\n* Study arrhythmia secondary to reversible cause, or secondary to electrolyte imbalance, thyroid disease, or non cardiac cause\n* Patients requiring left atrial procedures: left atrial size greater than (\\>) 55 millimeter (mm)\n* Left ventricular ejection fraction(LVEF) less than or equal to (\\\u003C=) 25 percentage (%) for participants with ventricular arrhythmia\n* LVEF \\\u003C= 40% for participants with atrial arrhythmia\n* Documented intracardiac thrombus as detected on imaging within 24 hours prior to insertion of the investigational catheter\n* Contraindication to anticoagulation (that is, heparin, warfarin, dabigatran)\n* History of blood clotting or bleeding abnormalities (example hypercoagulable state)\n* Myocardial infarction within the past 2 months (60 days)\n* Documented thromboembolic event (including transient ischemic attack \\[TIA\\]) within the past 12 months (365 days)\n* Uncontrolled heart failure or New York heart association (NYHA) function class IV\n* Implanted with a pacemaker or intracardiac cardiac defibrillator or appendage closure device within the past 6 weeks (42 days)\n* Patients with known untreatable allergy to contrast media\n* Active illness or active systemic infection or sepsis\n* Diagnosed atrial or ventricular myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation\n* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study\n* Participants that have ever undergone a percutaneous or surgical valvular cardiac procedure (that is, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)\n* Participants that currently have Impella or equivalent devices on the procedure date or up to 7 days prior\n* Any cardiac surgery within the past 60 days (2 months) (includes percutaneous coronary intervention \\[PCI\\])\n* Atrial septal closure within the past 6 weeks (42 days)\n* Presence of a condition that precludes vascular access\n* Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation\n* Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being\n* Concurrent enrollment in an investigational study evaluating another device or drug",{"count":189,"type":22},60,[25],"The purpose of this study is to assess the safety and feasibility of the investigational catheter for mapping the atrial and ventricular regions of the heart.",[193,194,195,196,197,198,199,200,201,202],"Scar-related Atrial Tachycardia","Persistent Atrial Fibrillation","Paroxysmal Atrial Fibrillation","Ventricular Procedures","Ventricular Tachycardia","Ischemic Ventricular Tachycardia","Non-ischemic Ventricular Tachycardia","Cardiomyopathy","Idiopathic Ventricular Tachycardia","Premature Ventricular Contraction","2026-02-12",{"date":205,"type":33},"2026-02-13",{"date":207,"type":33},"2025-09-15",{"date":209,"type":22},"2026-09-30",{"name":39,"class":40},6,""]