PVAC GOLD versus Irrigated RF single tip Catheter with Contact FORCE Ablation of the Pulmonary Veins for treatment of drug refractory Symptomatic Paroxysmal and Persistent Atrial Fibrillatio
Phase 4
Recruiting
- Conditions
- paroxysmal atrial fibrillation10007521
- Registration Number
- NL-OMON47914
- Lead Sponsor
- Sint Antonius Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
Symptomatic Atril Fibrillation, refractory to anti-arrhythmic drugs, with a guideline indication for ablation
Exclusion Criteria
prior ablation, dilated atria, prior stroke, significant structural disease requiring invasive treatment, valvular repair/replacement
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Effectiveness: Freedom of AF during 1 yr follow-up<br /><br>Burden of AF<br /><br>Safety: Serious Adverse Events during 30 days post-procedure </p><br>
- Secondary Outcome Measures
Name Time Method <p>Effectiveness: Symptom reduction, procedure times, findings during redo<br /><br>procedure<br /><br>Safety: Serious adverse events during 1 yr follow-up</p><br>