Randomized comparison of two contemporary balloon devices in catheter ablation of atrial fibrillation - Cryoballoon versus Laserballon II
- Conditions
- I48.0I48.1Paroxysmal atrial fibrillationPersistent atrial fibrillation
- Registration Number
- DRKS00012423
- Lead Sponsor
- CCB Cardioangiologisches Centrum Bethanien, Markus Krankenhaus
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 200
Paroxysmal and persistent atrial fibrillation with an episode duration of > 7 days and < 1 year or patients with electrical cardioversion > 48 h after atrial fibrillation episode onset
- Ineffective treatment with at least one antiarrhythmic drug (class I-III) or betablocker
- Age 18 - 80 years
- Left atrial size < 45 mm
- Left ventricular ejection fraction > 45 %
- Patient is able to provide informed consent
- Contraindications for pulmonary vein isolation
- Previous pulmonary vein isolation attempts
- Inability to be treated with oral anticoagulation
- Presence of intracardiac thrombi
- Pregnancy
- Participation in other clinical studies
- Mitral regurgitation = III°
- Moderate mitral stenosis
- Unwilling to follow the study protocol and to attend follow-up visits
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Documented (ECG and CRF (90-days-, 180-days-, 360-days-Follow Up)) recurrence of atrial fibrillation or any atrial tachyarrhythmia lasting > 30 seconds between day 90 and 365 after the index procedure.
- Secondary Outcome Measures
Name Time Method - Incidence of peri-procedural complications such as: major bleeding requiring intervention, phrenic nerve palsy, pericardial tamponade, thromboembolic events, death<br>- Number of gaps in the ablation line during the repeat procedure<br>- Multiple procedure success rate