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

NCT04750798 | Recruiting FDA Device

• 1 other identifier: BWI_2019_05
• Study Type: observational
• Target: 8,000
• Locations: 14 countries
• Sites: 40

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.

Conditions

Arrhythmias, Cardiac

Outcome Measures

Primary Outcomes (8)

• 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.

  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

Secondary Outcomes (19)

• 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 Non-Serious Adverse Events (Non-Serious Adverse Device Effects [ADEs])

  Up to 365 Days

• AF: Number of Participants with Acute Reconnection Among all Targeted Pulmonary Veins (PVs)

  Up to 7 Days

• SVT (MRAT): Number of Participants with Non-inducibility of the Targeted Tachycardia at end of Procedure

  Up to 7 Days

• SVT (AVNRT): Number of Participants with Elimination or Modification of Slow Pathway Conduction

  Up to 7 Days

Other Outcomes (6)

• VARIPURE sub-study: Number of Participants With Coronary Spasm During Ablation

  Up to Day 365

• VARIPURE Sub-Study: Number of Participants With Vagal Response During Ablation

  Up to Day 365

• VARIPURE Sub-Study: Number of Participants With Acute Kidney Failure Post Ablation

  Up to Day 365

Study Arms (1)

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.

Device: BWI Medical Device; Device: Varipulse Catheter; Device: Dual Energy THERMOCOOL SMARTTOUCH SF Catheter

Interventions

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.

Participants Diagnosed with Cardiac Arrhythmias

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.

Participants Diagnosed with Cardiac Arrhythmias

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.

Participants Diagnosed with Cardiac Arrhythmias

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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
• Able and willing to comply with all pre, post and follow-up testing and requirements as per hospital standard of care
• Signed patient informed consent form (ICF) as applicable per local regulation

You may not qualify if:

• Currently participating in an interventional (drug, device, biologic) clinical trial
• Life expectancy of less than 12-months
• Presenting any contraindication for the use of BWI commercially approved medical devices, as indicated in the respective user manuals

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (40)

Medical University of Graz

Graz, 8010, Austria

RECRUITING

Ordensklinikum Linz GMBH

Linz, 4020, Austria

RECRUITING

NÖ Landesgesundheitsagentur

Sankt Pölten, 3100, Austria

RECRUITING

OLV Aalst

Aalst, 9300, Belgium

RECRUITING

AZ Sint-Jan Brugge

Bruges, 8000, Belgium

RECRUITING

CHU Saint-Pierre

Brussels, 1000, Belgium

RECRUITING

UZ Antwerp

Edegem, 2650, Belgium

RECRUITING

Jessa Hospital

Hasselt, 3500, Belgium

RECRUITING

UZ Brussels

Jette, 1090, Belgium

RECRUITING

ASBL CHU HELORA Hôpital de La Louvière site Jolimont

La Louvière, 7100, Belgium

RECRUITING

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Les Hospices Civils de Lyon

Lyon, 69002, France

RECRUITING

Hôpital Saint Joseph de Marseille

Marseille, 13285, France

RECRUITING

Institut Mutualiste Montsouris

Paris, 75674, France

RECRUITING

Centre Hospitalier Universitaire de Bordeaux

Talence, 33404, France

RECRUITING

Rhön-Klinikum Campus Bad Neustadt

Bad Neustadt an der Saale, 97616, Germany

RECRUITING

Herz- und Diabeteszentrum NRW, University Hospital of the Ruhr University Bochum

Bad Oeynhausen, 3245, Germany

RECRUITING

Segeberger Kliniken

Bad Segeberg, 23795, Germany

RECRUITING

Alfried Krupp Hospital

Essen, 45131, Germany

RECRUITING

Cardioangiologisches Centrum Bethanien (CCB)

Frankfurt, 60431, Germany

COMPLETED

Justus-Liebig-University Giessen

Giessen, 35390, Germany

RECRUITING

Asklepios Klinik Altona

Hamburg, 22763, Germany

RECRUITING

German Heart Centre Munich

Munich, 80636, Germany

RECRUITING

Semmelweis University

Budapest, H-1085, Hungary

RECRUITING

Mater Private Heart and Vascular Centre

Dublin, D07 WKW8, Ireland

RECRUITING

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

RECRUITING

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

RECRUITING

Ospedale Generale Regionale "F. Miulli"

Acquaviva delle Fonti, 70021, Italy

RECRUITING

IRCCS Policlinico San Donato

Milan, 20097, Italy

RECRUITING

Clinica Mediterranea

Naples, 80122, Italy

RECRUITING

Clinical Trial Center Maastricht

Maastricht, 6229 EV, Netherlands

RECRUITING

Erasmus University Medical Center

Rotterdam, 3015 GD, Netherlands

RECRUITING

Hospital de Santa Cruz

Carnaxide, 2790-134, Portugal

RECRUITING

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

RECRUITING

INSELSPITAL Universitätsspital Bern

Bern, 03010, Switzerland

RECRUITING

Glenfield Hospital

Leicester, LE3 9QP, United Kingdom

RECRUITING

St. Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

COMPLETED

St George's Hospital

London, SW17 0QT, United Kingdom

RECRUITING

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Biosense Webster, Inc. Clinical Trial

  Biosense Webster, Inc.

  STUDY DIRECTOR

Central Study Contacts

Nathalie Macours

CONTACT

+32 479 97 05 05; nmacours1@its.jnj.com

Liesbeth Gorissen

CONTACT

LGORISSE@ITS.JNJ.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 11, 2021
• Study Start: February 22, 2021
• Primary Completion (Estimated): December 31, 2036
• Study Completion (Estimated): December 31, 2037
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

FR (4); PT (1); SE (1); IT (3); NL (2); IL (2); GB (4); DK (2); BE (7); DE (8); AU (3); CH (1); IE (1); HU (1)