An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias

Recruiting

• Conditions: Cardiac Arrhythmias
• Interventions: Device: BWI Medical Device; Device: Varipulse Catheter

• Registration Number: NCT04750798
• Lead Sponsor: Biosense Webster, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-08
• Study First Posted: 2021-02-11
• Study Start: 2021-02-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-27
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants Diagnosed with Cardiac Arrhythmias	Varipulse Catheter	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 will be observed.
Participants Diagnosed with Cardiac Arrhythmias	BWI Medical Device	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 will be observed.

Primary Outcome Measures

Name	Time	Method
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	Up to 7 Days	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.
SVT (AVRT): Number of Participants with Complete Block of Accessory Pathway	Up to 7 Days	Number of participants with atrioventricular reentry tachycardia (AVRT) with complete block of accessory pathway will be reported.
VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant Premature Ventricular Contraction (PVCs)	Up to 7 days	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.
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	Up to 7 Days	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.
AF: Number of Participants with Isolation of all Targeted Pulmonary Veins	Up to 7 Days	Number of Participants with isolation (entrance block confirmation) of all targeted pulmonary veins will be reported.
SVT (MRAT): Number of Participants with Complete Bidirectional Conduction Block Across the Ablation Line	Up to 7 Days	Number of participants with Macro Re-entrant Atrial Tachycardia (MRAT) with complete bidirectional conduction block across the ablation line will be reported.
VT (Ischemic or Non-ischemic): Number of Participants with Non-inducibility of the Targeted VT at end of Procedure	Up to 7 days	Number of participants with non-inducibility of the targeted ischemic or non-ischemic VT at end of procedure will be reported.
VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant VT	Up to 7 days	Number of participants with elimination of clinically relevant idiopathic VT will be reported. Clinically relevant: any spontaneous VT or any induced VT.

Secondary Outcome Measures

Name	Time	Method
VT (Ischemic or Non-ischemic): Number of Participants with Non-inducibility of any VT at end of Procedure	Up to 7 Days	Number of participants with non-inducibility of any VT (Ischemic or Non-ischemic) at end of procedure will be reported.
SVT: Number of Participants with Repeated Ablation	From Day 1 to Day 365	Number of participants with repeated ablation will be reported.
VT: Number of Participants with Freedom From Documented Arrhythmia of the Clinically Relevant/Targeted VT	From Day 1 to Day 365	Number of participants with freedom from documented arrhythmia of the clinically relevant /targeted VT (episodes \>=30 seconds) will be reported.
AF: Number of Participants with Acute Reconnection Among all Targeted Pulmonary Veins (PVs)	Up to 7 Days	Number of participants with Acute reconnection among all targeted PVs will be reported.
AF: Number of Participants with Freedom From Documented Symptomatic AF, AT, AFL Episodes	From Day 91 to Day 365 (post-blanking)	Number of participants with freedom from documented symptomatic AF, AT, AFL episodes (episodes \>= 30 seconds) post-blanking will be reported.
SVT: Number of Participants with Freedom From Documented Arrhythmia of the Primary SVT	From Day 1 to Day 365	Number of participants with freedom from documented arrhythmia of the primary SVT (episodes \>=30 seconds) will be reported.
SVT: Change in Study Arrhythmia Burden Compared to Baseline for Participants with Implantable Arrhythmia Monitoring Device	From Day 1 to Day 365	Study arrhythmia burden will be measured as the change in the percentage of time that participants will be in study arrhythmia (symptomatic and asymptomatic) compared to baseline will be calculated. The change in study arrhythmia for the overall study population will be calculated and expressed.
SVT (AVNRT): Number of Participants with Elimination or Modification of Slow Pathway Conduction	Up to 7 Days	Number of participants with AVNRT with elimination or modification of slow pathway conduction will be reported.
Number of Participants with Device and/or Procedure-Related Serious Adverse Events (Serious Adverse Device Effects [SADEs])	Up to 365 Days	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.
Number of Participants with Device and/or Procedure-Related Non-Serious Adverse Events (Non-Serious Adverse Device Effects [ADEs])	Up to 365 Days	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.
SVT (MRAT): Number of Participants with Non-inducibility of the Targeted Tachycardia at end of Procedure	Up to 7 Days	Number of participants with MRAT with non-inducibility of the targeted tachycardia at end of procedure will be reported.
AF: Number of Participants with Freedom From Documented (Symptomatic and Asymptomatic) AF, AT, Atrial Flutter (AFL) Episodes	From Day 91 to Day 365 (post-blanking)	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.
AF: Change in AF Burden Compared to Baseline for Participants with Implantable Arrhythmia Monitoring Device	Baseline, Day 91 up to Day 365	AF burden will be measured as the change in the percentage of time that participants will be in AF (symptomatic and asymptomatic) compared to baseline will be calculated. The change in AF burden for the overall study population will be calculated and expressed.
SVT: Number of Participants with Freedom From Documented Arrhythmia of new SVT, not Targeted During Index Procedure	From Day 1 to Day 365	Number of participants with freedom from documented arrhythmia of new SVT, not targeted during index procedure will be reported.
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	Up to 7 Days	Number of participants with elimination of all targeted late potentials and local abnormal ventricular activation (LAVAs) at end of procedure will be reported.
AF: Number of Participants with Repeated Ablation	From Day 91 to Day 365 (post-blanking)	Number of participants with repeated ablation post-blanking will be reported.
AF: Number of Participants with Repeated Ablation with Pulmonary Vein (PV) Reconnection	From Day 91 to Day 365 (post-blanking)	Number of participants with repeated ablation with PV reconnection post blanking will be reported.
VT: Number of Participants with Freedom From Documented Arrhythmia of new VT, not Targeted During Index Procedure	From Day 1 to Day 365	Number of participants with freedom from documented arrhythmia of new VT, not targeted during index procedure will be reported.
VT: Number of Participants with Repeated Ablation	From Day 1 to Day 365	Number of participants with repeated ablation will be reported.
VT: Number of Participants with All Cause and Cardiac Mortality	Up to Day 365	Number of participants with all cause and cardiac mortality will be reported.
VT: Number of Participants with Heart Failure Hospitalization	Up to Day 365	Number of participants with heart failure hospitalization will be reported.
VT (For Participants with Continuous Arrhythmia Monitoring): Number of Participants with PVC Burden	Up to Day 365	Number of participants with PVC burden for participants with continuous arrhythmia monitoring will be reported based on criterias such as % PVC beats/total beats and at least 80% reduction in PVC burden.
VT (For Participants with Implantable Arrhythmia Monitoring): Number of Participants with VT Burden	Up to Day 365	Number of participants with VT burden for participants with implantable arrhythmia monitoring will be reported based on criterias such as implantable cardioverter defibrillator (ICD) shocks (appropriate and inappropriate), appropriate antitachycardia pacing therapy (ATP), VT episodes and at least 75% reduction in VT burden.

Trial Locations

Locations (30)

Medical University of Graz; 🇦🇹 Graz, Austria

Ordensklinikum Linz GMBH; 🇦🇹 Linz, Austria

OLV Aalst; 🇧🇪 Aalst, Belgium

AZ Sint-Jan Brugge; 🇧🇪 Brugge, Belgium

CHU Saint-Pierre; 🇧🇪 Brussels, Belgium

UZ Antwerp; 🇧🇪 Edegem, Belgium

Jessa Hospital; 🇧🇪 Hasselt, Belgium

UZ Brussels; 🇧🇪 Jette, Belgium

ASBL CHU HELORA Hôpital de La Louvière site Jolimont; 🇧🇪 La Louvière, Belgium

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Les Hospices Civils de Lyon; 🇫🇷 Lyon, France

Institut Mutualiste Montsouris; 🇫🇷 Paris, France

Centre Hospitalier Universitaire de Bordeaux; 🇫🇷 Talence, France

Rhön-Klinikum Campus Bad Neustadt; 🇩🇪 Bad Neustadt an der Saale, Germany

Herz- und Diabeteszentrum NRW, University Hospital of the Ruhr University Bochum; 🇩🇪 Bad Oeynhausen, Germany

Cardioangiologisches Centrum Bethanien (CCB); 🇩🇪 Frankfurt, Germany

German Heart Centre Munich; 🇩🇪 Munich, Germany

Mater Private Heart and Vascular Centre; 🇮🇪 Dublin, Ireland

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

Ospedale Generale Regionale "F. Miulli"; 🇮🇹 Acquaviva delle Fonti, Italy

IRCCS Policlinico San Donato; 🇮🇹 Milan, Italy

Clinical Trial Center Maastricht; 🇳🇱 Maastricht, Netherlands

Erasmus University Medical Center; 🇳🇱 Rotterdam, Netherlands

Hospital de Santa Cruz; 🇵🇹 Carnaxide, Portugal

INSELSPITAL Universitätsspital Bern; 🇨🇭 Bern, Switzerland

Glenfield Hospital; 🇬🇧 Leicester, United Kingdom

St. Bartholomew's Hospital; 🇬🇧 London, United Kingdom

St George's Hospital; 🇬🇧 London, United Kingdom

Royal Brompton Hospital; 🇬🇧 London, United Kingdom