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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Arrhythmias
• Intervention / Treatment: Device: BWI Medical Device; Device: Varipulse Catheter

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Nathalie Macours; Phone Number: +32 479 97 05 05; Email: nmacours1@its.jnj.com

Study Locations

• Austria
  • Linz, Austria, 4020
    • Recruiting
    • Ordensklinikum Linz GmbH
• Belgium
  • Aalst, Belgium, 9300
    • Recruiting
    • OLV Aalst
  • Brugge, Belgium, 8000
    • Recruiting
    • AZ Sint-Jan Brugge
  • Edegem, Belgium, 2650
    • Recruiting
    • UZ Antwerp
  • Hasselt, Belgium, 3500
    • Recruiting
    • Jessa Hospital
  • Jette, Belgium, 1090
    • Recruiting
    • UZ Brussels
  • La Louvière, Belgium, 7100
    • Recruiting
    • ASBL CHU HELORA Hôpital de La Louvière site Jolimont
• France
  • Talence, France, 33404
    • Recruiting
    • Centre Hospitalier Universitaire de Bordeaux
• Germany
  • Bad Neustadt an der Saale, Germany, 97616
    • Recruiting
    • Rhön-Klinikum Campus Bad Neustadt
  • Frankfurt, Germany, 60431
    • Recruiting
    • Cardioangiologisches Centrum Bethanien (CCB)
  • Munich, Germany, 80636
    • Recruiting
    • German Heart Centre Munich
• Ireland
  • Dublin, Ireland, D07 WKW8
    • Recruiting
    • Mater Private Heart and Vascular Centre
• Israel
  • Jerusalem, Israel, 9103102
    • Recruiting
    • Shaare Zedek Medical Center
  • Tel Aviv, Israel, 6423906
    • Recruiting
    • Tel Aviv Sourasky Medical Center
• Italy
  • Acquaviva delle Fonti, Italy, 70021
    • Recruiting
    • Ospedale Generale Regionale "F. Miulli"
• United Kingdom
  • Leicester, United Kingdom, LE3 9QP
    • Recruiting
    • Glenfield Hospital
  • London, United Kingdom, SW17 0QT
    • Recruiting
    • St George's Hospital
  • London, United Kingdom, EC1A 7BE
    • Recruiting
    • St. Bartholomew's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion criteria

• 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

Exclusion criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 will be observed.	Device: BWI Medical Device; Participants will be treated with commercially approved BWI medical devices following routine clinical practice. No specific intervention will be observed for this study.; Device: Varipulse Catheter; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	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
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 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)
AF: Change in AF Burden Compared to Baseline for Participants with Implantable Arrhythmia Monitoring Device	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.	Baseline, Day 91 up 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
SVT: Change in Study Arrhythmia Burden Compared to Baseline for Participants with Implantable Arrhythmia Monitoring Device	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.	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
VT (For Participants with Continuous Arrhythmia Monitoring): Number of Participants with PVC Burden	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.	Up to Day 365
VT (For Participants with Implantable Arrhythmia Monitoring): Number of Participants with VT Burden	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.	Up to Day 365
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)
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
VARIPURE sub-study: Assessment of Learning Curve	Learning curve will be assessed to evaluate the clinical utilization of the Varipulse Catheter in a routine-use setting.	Up to Day 365
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	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

Collaborators and Investigators

• Sponsor: Biosense Webster, Inc.
• Investigators: Study Director: Biosense Webster, Inc. Clinical Trial, Biosense Webster, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: BWI_2019_05 (Other Identifier: Biosense Webster EMEA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel

for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes