CARTO® 3 System-guided RF Ablation Using the THERMOCOOL® Catheter Versus Fluoroscopy-guided RF Ablation Using the Pulmonary Vein Ablation Catheter® (PVAC®) in Subjects with Paroxysmal Atrial Fibrillation: A Prospective, Multi-center, Randomized (2:1), Controlled, Two-arm, Unblinded Clinical Study
- Conditions
- atrial tachyarrhythmiaquivering of the heart muscles of the atria10007521
- Registration Number
- NL-OMON34575
- Lead Sponsor
- Johnson & Johnson
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Patients with PAF who have had two (2) symptomatic PAF episodes in the six (6) months prior to randomization, and who are selected for catheter ablation for the treatment of their AF. Additionally patients with recurrent AF with episodes up to 30 days with sinus rhythm maintained for more than one week following cardioversion and who require PVI only for the treatment of their AF. AT least one AF episode should be documented either on ECG, TTM, HM or telemetry strip.
1. Longstanding persistent atrial fibrillation
2. Patients with a history of any atrial flutter requiring ablation in the right atrium during the study procedure
3. Patients in whom sinus rhythm was maintained for less than 1 week after electrical cardioversion
4. Previous ablation for AF
5. LA size > 55 mm
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoints supporting the objective are:<br /><br><br /><br>Efficacy: Freedom from documented AF/AT recurrences without new AADs through 1<br /><br>year follow-up<br /><br><br /><br>Safety: Incidence of PV Stenosis (number of PVs with a reduction in diameter >=<br /><br>50% at 6 months compared to baseline per CT or MRI)<br /><br><br /><br>Efficiency: Total procedure time (minutes from introduction of first catheter<br /><br>to withdrawal of last catheter) </p><br>
- Secondary Outcome Measures
Name Time Method