Pulmonary vein isolation using focal pulsed field ablation versus very-high power short duration radiofrequency ablation: a quasi-randomized study
Not Applicable
Recruiting
- Conditions
- I48Atrial fibrillation and flutter
- Registration Number
- DRKS00032756
- Lead Sponsor
- niversitätsklinikum Düsseldorf
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Paroxysmal or persistent atrial fibrillation
Exclusion Criteria
Contraindications for oral anticoagulation
Contraindications for the pulmonary vein isolation
Left atrial diameter >6 cm
Left atrial redo procedures
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Freedom of atrial tachyarrhythmias during the first year after ablation. Per definition we search for sustained atrial arrhythmias over 30 seconds. The endpoint is assessed based on symptoms and using Holter ECGs. The Holter ECGs are planed at 3, 6 and 12 months after the procedure, as well as symptom-triggered.
- Secondary Outcome Measures
Name Time Method Improvement of symptoms. We aim to document the change in AFEQT (AF Effect On Quality-Of-Life Questionnaire) questionnaire before and after the ablation (3,6 and 12 months).<br>Safety - the intra- and postprocedural occurrence of major complications, defined as: pericardial tamponade, stroke, major groin complication, phrenic nerve injury, atrio-esophageal fistula.