Status:
RECRUITING
An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias
Lead Sponsor:
Biosense Webster, Inc.
Conditions:
Arrhythmias, Cardiac
Eligibility:
All Genders
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 whil...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 22 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2037
Estimated Enrollment :
8000 Patients enrolled
Trial Details
Trial ID
NCT04750798
Start Date
February 22 2021
End Date
December 31 2037
Last Update
March 13 2026
Active Locations (38)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical University of Graz
Graz, Austria, 8010
2
Ordensklinikum Linz GMBH
Linz, Austria, 4020
3
NÖ Landesgesundheitsagentur
Sankt Pölten, Austria, 3100
4
OLV Aalst
Aalst, Belgium, 9300