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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/or 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants Diagnosed with Cardiac Arrhythmias | Patients diagnosed with cardiac arrhythmias who are scheduled to undergo an ablation procedure in routine clinical practice for management of their arrhythmia with a BWI therapeutic catheter/Varipulse Catheter/ Dual Energy Thermocool Smarttouch surround flow (SF) catheter will be observed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BWI Medical Device | Device | Participants will be treated with commercially approved BWI medical devices following routine clinical practice. No specific intervention will be observed for this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Primary Adverse Events (PAEs) Related to Device in Scope and/or Study Procedure Within 7 Days of the Initial Study Procedure | PAEs in participants with Atrial Fibrillation (AF) and for SupraVentricular Tachycardia (SVT) includes device or procedure related death, atrio-esophageal fistula/ esophageal perforation , severe pulmonary vein stenosis, cardiac tamponade/perforation, thromboembolism, pericarditis, stroke/cerebrovascular accident, transient ischemic attack, phrenic nerve paralysis (permanent), myocardial infarction, major vascular access complication/bleeding, heart block; PAEs in participants with Ventricular Tachycardia (VT) includes device or procedure related death, cardiac tamponade/perforation, thromboembolism, pericarditis, stroke/cerebrovascular accident, transient ischemic attack, phrenic nerve paralysis (permanent), myocardial infarction, major vascular access complication/bleeding, heart block, aggravation or new onset heart failure, coronary artery injury, aortic dissection and valve injury. | Up to 7 Days |
| AF: Number of Participants with Isolation of all Targeted Pulmonary Veins | Number of Participants with isolation (entrance block confirmation) of all targeted pulmonary veins will be reported. | Up to 7 Days |
| SVT (Sinus Nodal Re-entrant Tachycardia, Focal AT, Multifocal AT, AVNRT, Non Re-entrant Junctional Tachycardias): Number of Participants with Non-inducibility of the Targeted Tachycardia at end of Procedure | Number of participants with sinus nodal re-entrant tachycardia, focal atrial tachycardia (AT) multifocal AT, atrioventricular nodal reentry tachycardia (AVNRT), non re-entrant junctional tachycardias with non-inducibility of the targeted tachycardia at end of procedure will be reported. | Up to 7 Days |
| SVT (MRAT): Number of Participants with Complete Bidirectional Conduction Block Across the Ablation Line | Number of participants with Macro Re-entrant Atrial Tachycardia (MRAT) with complete bidirectional conduction block across the ablation line will be reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Device and/or Procedure-Related Serious Adverse Events (Serious Adverse Device Effects [SADEs]) | Number of participants with device and/or procedure-related Serious Adverse Events (SADEs) within 7 days (early-onset), >7-30 days (peri-procedural) and >30 days (late onset) following the initial study procedure will be reported. | Up to 365 Days |
| Measure | Description | Time Frame |
|---|---|---|
| VARIPURE sub-study: Number of Participants With Coronary Spasm During Ablation | Ablation procedures using the varipulse medical device will be performed according to the hospital standard practice. Number of participants with coronary spasm during ablation will be reported. | Up to Day 365 |
| VARIPURE Sub-Study: Number of Participants With Vagal Response During Ablation |
Inclusion criteria
Exclusion criteria:
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Study population consists of participants diagnosed with cardiac arrhythmias who are scheduled to undergo an ablation procedure for management of their arrhythmia with a per-protocol defined Biosense Webster Inc (BWI) therapeutic catheter.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nathalie Macours | Contact | +32 479 97 05 05 | nmacours1@its.jnj.com | |
| Liesbeth Gorissen | Contact | LGORISSE@ITS.JNJ.com |
| Name | Affiliation | Role |
|---|---|---|
| Biosense Webster, Inc. Clinical Trial | Biosense Webster, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Recruiting | Graz | 8010 | Austria | ||
| Ordensklinikum Linz GMBH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42392466 | Derived | Almorad A, Sebag FA, Kronborg MB, Sohns C, De Potter T, Adragao P, Bessiere F, Chierchia GB, Duytschaever M, Szeplaki G, Di Monaco A, Reichlin T, Yap SC, Wong T, Lepiece C, Linz D, Gallagher MM, Pappone C, Sommer P, Ernst S, Purerfellner H, Scherr D; VARIPURE Investigators. Pulsed Field Ablation With a Variable Loop Circular Catheter in Atrial Fibrillation: Acute Outcomes From the VARIPURE Multicenter Study. Heart Rhythm. 2026 Jul 2:S1547-5271(26)02516-6. doi: 10.1016/j.hrthm.2026.06.040. Online ahead of print. |
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The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
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| Varipulse Catheter | Device | Participants treated with Varipulse Catheter in the main study will be part of the VARIPURE sub-study. No specific intervention will be observed for this study. |
|
| Dual Energy THERMOCOOL SMARTTOUCH SF Catheter | Device | Participants treated with the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter in the main study will be part of the DUACURE sub-study. No specific intervention will be observed for this study. |
|
| Up to 7 Days |
| SVT (AVRT): Number of Participants with Complete Block of Accessory Pathway | Number of participants with atrioventricular reentry tachycardia (AVRT) with complete block of accessory pathway will be reported. | Up to 7 Days |
| VT (Ischemic or Non-ischemic): Number of Participants with Non-inducibility of the Targeted VT at end of Procedure | Number of participants with non-inducibility of the targeted ischemic or non-ischemic VT at end of procedure will be reported. | Up to 7 days |
| VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant VT | Number of participants with elimination of clinically relevant idiopathic VT will be reported. Clinically relevant: any spontaneous VT or any induced VT. | Up to 7 days |
| VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant Premature Ventricular Contraction (PVCs) | Number of participants with elimination of clinically relevant idiopathic PVCs will be reported. Clinically relevant: any spontaneous PVC or any induced PVC; prior to treatment, PVCs would be deemed clinically relevant if they are present greater than (>) 20 percent (%) of daily heartbeat. | Up to 7 days |
| Number of Participants with Device and/or Procedure-Related Non-Serious Adverse Events (Non-Serious Adverse Device Effects [ADEs]) | Number of participants with device and/or procedure-related non-serious adverse events (Non-serious ADEs) within 7 days (early-onset), >7-30 days (peri-procedural) and >30 days (Late Onset) following the initial study procedure will be reported. | Up to 365 Days |
| AF: Number of Participants with Acute Reconnection Among all Targeted Pulmonary Veins (PVs) | Number of participants with Acute reconnection among all targeted PVs will be reported. | Up to 7 Days |
| SVT (MRAT): Number of Participants with Non-inducibility of the Targeted Tachycardia at end of Procedure | Number of participants with MRAT with non-inducibility of the targeted tachycardia at end of procedure will be reported. | Up to 7 Days |
| SVT (AVNRT): Number of Participants with Elimination or Modification of Slow Pathway Conduction | Number of participants with AVNRT with elimination or modification of slow pathway conduction will be reported. | Up to 7 Days |
| VT (Ischemic or Non-ischemic): Number of Participants with Non-inducibility of any VT at end of Procedure | Number of participants with non-inducibility of any VT (Ischemic or Non-ischemic) at end of procedure will be reported. | Up to 7 Days |
| VT (Ischemic or Non-ischemic): Number of Participants with Elimination of all Targeted Late Potentials and Local Abnormal Ventricular Activation (LAVAs) at end of Procedure | Number of participants with elimination of all targeted late potentials and local abnormal ventricular activation (LAVAs) at end of procedure will be reported. | Up to 7 Days |
| AF: Number of Participants with Freedom From Documented (Symptomatic and Asymptomatic) AF, AT, Atrial Flutter (AFL) Episodes | Number of participants with freedom from documented (symptomatic and asymptomatic) AF, AT, AFL episodes (episodes greater than or equal to [>=] 30 seconds) post-blanking will be reported. | From Day 91 to Day 365 (post-blanking) |
| AF: Number of Participants with Freedom From Documented Symptomatic AF, AT, AFL Episodes | Number of participants with freedom from documented symptomatic AF, AT, AFL episodes (episodes >= 30 seconds) post-blanking will be reported. | From Day 91 to Day 365 (post-blanking) |
| AF: Number of Participants with Repeated Ablation | Number of participants with repeated ablation post-blanking will be reported. | From Day 91 to Day 365 (post-blanking) |
| AF: Number of Participants with Repeated Ablation with Pulmonary Vein (PV) Reconnection | Number of participants with repeated ablation with PV reconnection post blanking will be reported. | From Day 91 to Day 365 (post-blanking) |
| SVT: Number of Participants with Freedom From Documented Arrhythmia of the Primary SVT | Number of participants with freedom from documented arrhythmia of the primary SVT (episodes >=30 seconds) will be reported. | From Day 1 to Day 365 |
| SVT: Number of Participants with Freedom From Documented Arrhythmia of new SVT, not Targeted During Index Procedure | Number of participants with freedom from documented arrhythmia of new SVT, not targeted during index procedure will be reported. | From Day 1 to Day 365 |
| SVT: Number of Participants with Repeated Ablation | Number of participants with repeated ablation will be reported. | From Day 1 to Day 365 |
| VT: Number of Participants with Freedom From Documented Arrhythmia of the Clinically Relevant/Targeted VT | Number of participants with freedom from documented arrhythmia of the clinically relevant /targeted VT (episodes >=30 seconds) will be reported. | From Day 1 to Day 365 |
| VT: Number of Participants with Freedom From Documented Arrhythmia of new VT, not Targeted During Index Procedure | Number of participants with freedom from documented arrhythmia of new VT, not targeted during index procedure will be reported. | From Day 1 to Day 365 |
| VT: Number of Participants with Repeated Ablation | Number of participants with repeated ablation will be reported. | From Day 1 to Day 365 |
| VT: Number of Participants with All Cause and Cardiac Mortality | Number of participants with all cause and cardiac mortality will be reported. | Up to Day 365 |
| VT: Number of Participants with Heart Failure Hospitalization | Number of participants with heart failure hospitalization will be reported. | Up to Day 365 |
Ablation procedures using the varipulse medical device will be performed according to the hospital standard practice. Number of participants with vagal response during ablation will be reported. |
| Up to Day 365 |
| VARIPURE Sub-Study: Number of Participants With Acute Kidney Failure Post Ablation | Ablation procedures using the varipulse medical device will be performed according to the hospital standard practice. Number of participants with acute kidney failure post ablation will be reported. | Up to Day 365 |
| DUACURE Sub-Study: Number of Participants With Coronary Spasm During Ablation | Ablation procedures using the duacure medical device will be performed according to the hospital standard practice. Number of participants with coronary spasm during ablation will be reported. | Up to Day 365 |
| DUACURE Sub-Study: Number of Participants With Vagal Response During Ablation | Ablation procedures using the duacure medical device will be performed according to the hospital standard practice. Number of participants with vagal response during ablation will be reported. | Up to Day 365 |
| DUACURE Sub-Study: Number of Participants With Acute Kidney Failure Post Ablation | Ablation procedures using the duacure medical device will be performed according to the hospital standard practice. Number of participants with acute kidney failure post ablation will be reported. | Up to Day 365 |
| Recruiting |
| Linz |
| 4020 |
| Austria |
| Universitätsklinikum Wiener Neustadt | Recruiting | Wiener Neustadt | 2700 | Austria |
| OLV Aalst | Recruiting | Aalst | 9300 | Belgium |
| AZ Sint-Jan Brugge | Recruiting | Bruges | 8000 | Belgium |
| CHU Saint-Pierre | Recruiting | Brussels | 1000 | Belgium |
| UZ Antwerp | Recruiting | Edegem | 2650 | Belgium |
| Jessa Hospital | Recruiting | Hasselt | 3500 | Belgium |
| UZ Brussels | Recruiting | Jette | 1090 | Belgium |
| ASBL CHU HELORA Hôpital de La Louvière site Jolimont | Recruiting | La Louvière | 7100 | Belgium |
| Aarhus University Hospital | Recruiting | Aarhus | 8200 | Denmark |
| Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
| Les Hospices Civils de Lyon | Recruiting | Lyon | 69002 | France |
| Hôpital Saint Joseph de Marseille | Recruiting | Marseille | 13285 | France |
| Institut Mutualiste Montsouris | Recruiting | Paris | 75674 | France |
| Les Hôpitaux Universitaires de Strasbourg | Recruiting | Strasbourg | 67000 | France |
| Centre Hospitalier Universitaire de Bordeaux | Recruiting | Talence | 33404 | France |
| Rhön-Klinikum Campus Bad Neustadt | Recruiting | Bad Neustadt an der Saale | 97616 | Germany |
| Herz- und Diabeteszentrum NRW, University Hospital of the Ruhr University Bochum | Recruiting | Bad Oeynhausen | 3245 | Germany |
| Segeberger Kliniken | Recruiting | Bad Segeberg | 23795 | Germany |
| Alfried Krupp Hospital | Recruiting | Essen | 45131 | Germany |
| Cardioangiologisches Centrum Bethanien (CCB) | Completed | Frankfurt | 60431 | Germany |
| Justus-Liebig-University Giessen | Recruiting | Giessen | 35390 | Germany |
| Asklepios Klinik Altona | Recruiting | Hamburg | 22763 | Germany |
| German Heart Centre Munich | Recruiting | Munich | 80636 | Germany |
| Semmelweis University | Recruiting | Budapest | H-1085 | Hungary |
| Mater Private Heart and Vascular Centre | Recruiting | Dublin | D07 WKW8 | Ireland |
| Shaare Zedek Medical Center | Recruiting | Jerusalem | 9103102 | Israel |
| Tel Aviv Sourasky Medical Center | Recruiting | Tel Aviv | 6423906 | Israel |
| Ospedale Generale Regionale "F. Miulli" | Recruiting | Acquaviva delle Fonti | 70021 | Italy |
| IRCCS Policlinico San Donato | Recruiting | Milan | 20097 | Italy |
| Clinica Mediterranea | Recruiting | Naples | 80122 | Italy |
| Clinical Trial Center Maastricht | Recruiting | Maastricht | 6229 EV | Netherlands |
| Erasmus University Medical Center | Recruiting | Rotterdam | 3015 GD | Netherlands |
| Hospital de Santa Cruz | Recruiting | Carnaxide | 2790-134 | Portugal |
| Sahlgrenska University Hospital | Recruiting | Gothenburg | 413 45 | Sweden |
| INSELSPITAL Universitätsspital Bern | Recruiting | Bern | 03010 | Switzerland |
| Glenfield Hospital | Recruiting | Leicester | LE3 9QP | United Kingdom |
| St. Bartholomew's Hospital | Completed | London | EC1A 7BE | United Kingdom |
| St George's Hospital | Recruiting | London | SW17 0QT | United Kingdom |
| Royal Brompton Hospital | Recruiting | London | SW3 6NP | United Kingdom |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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