Observational study on the safety and performance of BWI medical devices for treating heart rhythm disorders
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
This study looks at how safe and effective certain heart devices are for people with heart rhythm disorders during their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 8000 (estimated) |
| Sex | All |
| Sponsor | Biosense Webster, Inc. Industry-sponsored |
| Locations | 39 sites (Graz and 38 other locations) |
| Trial ID | NCT04750798 on ClinicalTrials.gov |
What this trial studies
This study aims to collect clinical data on the safety and performance of Biosense Webster Inc. medical devices during standard cardiac arrhythmia mapping and ablation procedures. Participants diagnosed with specific types of arrhythmias will be monitored as they undergo treatment using these commercially approved devices. The data gathered will help confirm the ongoing safety and effectiveness of these devices in real-world clinical settings and contribute to the overall understanding of their use in managing cardiac arrhythmias.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with paroxysmal or persistent Atrial Fibrillation, supraventricular tachycardia, or ventricular tachycardia who are scheduled for an ablation procedure.
Not a fit: Patients currently involved in other interventional clinical trials or with a life expectancy of less than 12 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of treatments for patients with cardiac arrhythmias.
How similar studies have performed: Other studies have shown success with similar observational approaches in evaluating medical devices, indicating a potential for valuable insights from this study.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Graz and 38 other locations
- Medical University of Graz — Graz, Austria (Recruiting)
- Ordensklinikum Linz GMBH — Linz, Austria (Recruiting)
- NÖ Landesgesundheitsagentur — Sankt Pölten, Austria (Recruiting)
- OLV Aalst — Aalst, Belgium (Recruiting)
- AZ Sint-Jan Brugge — Bruges, Belgium (Recruiting)
- CHU Saint-Pierre — Brussels, Belgium (Recruiting)
- UZ Antwerp — Edegem, Belgium (Recruiting)
- Jessa Hospital — Hasselt, Belgium (Recruiting)
- UZ Brussels — Jette, Belgium (Recruiting)
- ASBL CHU HELORA Hôpital de La Louvière site Jolimont — La Louvière, Belgium (Recruiting)
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Les Hospices Civils de Lyon — Lyon, France (Recruiting)
- Hôpital Saint Joseph de Marseille — Marseille, France (Recruiting)
- Institut Mutualiste Montsouris — Paris, France (Recruiting)
- Centre Hospitalier Universitaire de Bordeaux — Talence, France (Recruiting)
- Rhön-Klinikum Campus Bad Neustadt — Bad Neustadt an der Saale, Germany (Recruiting)
- Herz- und Diabeteszentrum NRW, University Hospital of the Ruhr University Bochum — Bad Oeynhausen, Germany (Recruiting)
- Segeberger Kliniken — Bad Segeberg, Germany (Recruiting)
- Alfried Krupp Hospital — Essen, Germany (Recruiting)
- Cardioangiologisches Centrum Bethanien (CCB) — Frankfurt, Germany (Recruiting)
- Justus-Liebig-University Giessen — Giessen, Germany (Recruiting)
- Asklepios Klinik Altona — Hamburg, Germany (Recruiting)
- German Heart Centre Munich — Munich, Germany (Recruiting)
- Mater Private Heart and Vascular Centre — Dublin, Ireland (Recruiting)
- Shaare Zedek Medical Center — Jerusalem, Israel (Recruiting)
- Tel Aviv Sourasky Medical Center — Tel Aviv, Israel (Recruiting)
- Ospedale Generale Regionale "F. Miulli" — Acquaviva delle Fonti, Italy (Recruiting)
- IRCCS Policlinico San Donato — Milan, Italy (Recruiting)
- Clinica Mediterranea — Naples, Italy (Recruiting)
- Clinical Trial Center Maastricht — Maastricht, Netherlands (Recruiting)
- Erasmus University Medical Center — Rotterdam, Netherlands (Recruiting)
- Hospital de Santa Cruz — Carnaxide, Portugal (Recruiting)
- Sahlgrenska University Hospital — Gothenburg, Sweden (Recruiting)
- INSELSPITAL Universitätsspital Bern — Bern, Switzerland (Recruiting)
- Glenfield Hospital — Leicester, United Kingdom (Recruiting)
- St. Bartholomew's Hospital — London, United Kingdom (Completed)
- St George's Hospital — London, United Kingdom (Recruiting)
- Royal Brompton Hospital — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Nathalie Macours
- Email: nmacours1@its.jnj.com
- Phone: +32 479 97 05 05
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.