Observational study on the safety and performance of BWI medical devices for treating heart rhythm disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Medical University of Graz
  Graz, Austria Recruiting
• Ordensklinikum Linz GMBH
  Linz, Austria Recruiting
• Universitätsklinikum Wiener Neustadt
  Wiener Neustadt, Austria Recruiting
• OLV Aalst
  Aalst, Belgium Recruiting
• AZ Sint-Jan Brugge
  Bruges, Belgium Recruiting
• CHU Saint-Pierre
  Brussels, Belgium Recruiting

Study contacts

• Study coordinator: Nathalie Macours
• Email: nmacours1@its.jnj.com
• Phone: +32 479 97 05 05

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.