I48.0 I48.1
Conditions
Interventions
Group 1: pulmonary vein isolation with Cryoballoon (catheter ablation)
Group 2: pulmonary vein isolation with Laserballoon (catheter ablation)
Sponsors
CCB Cardioangiologisches Centrum Bethanien, Markus Krankenhaus
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: - Paroxysmal and persistent atrial fibrillation with an episode duration of > 7 days and 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 % - Patient is able to provide informed consent
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| - Incidence of peri-procedural complications such as: major bleeding requiring intervention, phrenic nerve palsy, pericardial tamponade, thromboembolic events, death - Number of gaps in the ablation line during the repeat procedure - Multiple procedure success rate | — |
Countries
Germany
Contacts
Public ContactInes Timmermanns
CCB Cardioangiologisches Centrum Bethanien, Markus Krankenhaus
Outcome results
None listed