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Recruiting NCT04750798

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

— Observational Arrhythmias, Cardiac

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BWI Medical Device, Varipulse Catheter, Dual Energy THERMOCOOL SMARTTOUCH SF Catheter.
Who it may be relevant to
Registry conditions: Arrhythmias, Cardiac. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria, Belgium, Denmark, France, Germany +9
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.
  • Device Dual Energy THERMOCOOL SMARTTOUCH SF Catheter
    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.

Primary outcome measures

  • 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 [Time frame: Up to 7 Days]
  • AF: Number of Participants with Isolation of all Targeted Pulmonary Veins [Time frame: 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 [Time frame: Up to 7 Days]
  • SVT (MRAT): Number of Participants with Complete Bidirectional Conduction Block Across the Ablation Line [Time frame: Up to 7 Days]
  • SVT (AVRT): Number of Participants with Complete Block of Accessory Pathway [Time frame: Up to 7 Days]
  • VT (Ischemic or Non-ischemic): Number of Participants with Non-inducibility of the Targeted VT at end of Procedure [Time frame: Up to 7 days]
  • VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant VT [Time frame: Up to 7 days]
  • VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant Premature Ventricular Contraction (PVCs) [Time frame: Up to 7 days]
Secondary outcome measures (12)
  • Number of Participants with Device and/or Procedure-Related Serious Adverse Events (Serious Adverse Device Effects [SADEs]) [Time frame: Up to 365 Days]
  • Number of Participants with Device and/or Procedure-Related Non-Serious Adverse Events (Non-Serious Adverse Device Effects [ADEs]) [Time frame: Up to 365 Days]
  • AF: Number of Participants with Acute Reconnection Among all Targeted Pulmonary Veins (PVs) [Time frame: Up to 7 Days]
  • SVT (MRAT): Number of Participants with Non-inducibility of the Targeted Tachycardia at end of Procedure [Time frame: Up to 7 Days]
  • SVT (AVNRT): Number of Participants with Elimination or Modification of Slow Pathway Conduction [Time frame: Up to 7 Days]
  • VT (Ischemic or Non-ischemic): Number of Participants with Non-inducibility of any VT at end of Procedure [Time frame: 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 [Time frame: Up to 7 Days]
  • AF: Number of Participants with Freedom From Documented (Symptomatic and Asymptomatic) AF, AT, Atrial Flutter (AFL) Episodes [Time frame: From Day 91 to Day 365 (post-blanking)]
  • AF: Number of Participants with Freedom From Documented Symptomatic AF, AT, AFL Episodes [Time frame: From Day 91 to Day 365 (post-blanking)]
  • AF: Number of Participants with Repeated Ablation [Time frame: From Day 91 to Day 365 (post-blanking)]
  • AF: Number of Participants with Repeated Ablation with Pulmonary Vein (PV) Reconnection [Time frame: From Day 91 to Day 365 (post-blanking)]
  • SVT: Number of Participants with Freedom From Documented Arrhythmia of the Primary SVT [Time frame: From Day 1 to Day 365]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 8 centers
  • Rhön-Klinikum Campus Bad Neustadt — Bad Neustadt an der Saale
  • Herz- und Diabeteszentrum NRW, University Hospital of the Ruhr University Bochum — Bad Oeynhausen
  • Segeberger Kliniken — Bad Segeberg
  • Alfried Krupp Hospital — Essen
  • Cardioangiologisches Centrum Bethanien (CCB) — Frankfurt
  • Justus-Liebig-University Giessen — Giessen
  • Asklepios Klinik Altona — Hamburg
  • German Heart Centre Munich — Munich
Belgium · 7 centers
  • OLV Aalst — Aalst
  • AZ Sint-Jan Brugge — Bruges
  • CHU Saint-Pierre — Brussels
  • UZ Antwerp — Edegem
  • Jessa Hospital — Hasselt
  • UZ Brussels — Jette
  • ASBL CHU HELORA Hôpital de La Louvière site Jolimont — La Louvière
France · 5 centers
  • Les Hospices Civils de Lyon — Lyon
  • Hôpital Saint Joseph de Marseille — Marseille
  • Institut Mutualiste Montsouris — Paris
  • Les Hôpitaux Universitaires de Strasbourg — Strasbourg
  • Centre Hospitalier Universitaire de Bordeaux — Talence
United Kingdom · 4 centers
  • Glenfield Hospital — Leicester
  • St. Bartholomew's Hospital — London
  • St George's Hospital — London
  • Royal Brompton Hospital — London
Austria · 3 centers
  • Medical University of Graz — Graz
  • Ordensklinikum Linz GMBH — Linz
  • Universitätsklinikum Wiener Neustadt — Wiener Neustadt
Italy · 3 centers
  • Ospedale Generale Regionale "F. Miulli" — Acquaviva delle Fonti
  • IRCCS Policlinico San Donato — Milan
  • Clinica Mediterranea — Naples
Denmark · 2 centers
  • Aarhus University Hospital — Aarhus
  • Rigshospitalet — Copenhagen
Israel · 2 centers
  • Shaare Zedek Medical Center — Jerusalem
  • Tel Aviv Sourasky Medical Center — Tel Aviv
Netherlands · 2 centers
  • Clinical Trial Center Maastricht — Maastricht
  • Erasmus University Medical Center — Rotterdam
Hungary · 1 center
  • Semmelweis University — Budapest
Ireland · 1 center
  • Mater Private Heart and Vascular Centre — Dublin
Portugal · 1 center
  • Hospital de Santa Cruz — Carnaxide
Sweden · 1 center
  • Sahlgrenska University Hospital — Gothenburg
Switzerland · 1 center
  • INSELSPITAL Universitätsspital Bern — Bern

Publications

  • 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 multice PMID 42392466

Identifiers

NCT: NCT04750798 · BWI_2019_05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗