- An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias — Recruiting • Cardiology / Cardiovascular • NCT04750798.
- What is being tested: Safety and performance of commercially approved Biosense Webster medical devices during routine cardiac arrhythmia mapping and ablation procedures in real-world clinical practice settings.
- Patient eligibility overview: Adults with cardiac arrhythmias requiring standard mapping and/or ablation procedures who are eligible for treatment with Biosense Webster devices, with specific inclusion/exclusion criteria determined by individual trial sites.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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.
- * 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.