Prevention of complications during atrial fibrillation ablation with the second-generation cryoballoo
Phase 4
Recruiting
- Conditions
- atrial fibrillationcardiac arrhythmia10007521
- Registration Number
- NL-OMON41330
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 75
Inclusion Criteria
Any patient with atrial fibrillation scheduled for a first ablation procedure
Exclusion Criteria
Previous catheter or surgical ablation for atrial fibrillation, (longstanding) persistent atrial fibrillation, a diameter of one or more pulmonary veins > 28 mm and > 3 veins on the right side
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The incidence of dormant conduction during the ablation procedure will be<br /><br>established en compared for three different ablation timeframes including 90,<br /><br>120 or 150 seconds of additional cryoballoon ablation after acute PV isolation</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. The efficacy of AF ablation with the second-generation cryoballoon at 1 year<br /><br>follow-up will be investigated and also compared for the three different<br /><br>ablation timeframes<br /><br><br /><br>2. The incidence of (transient) phrenic nerve injury for the three groups will<br /><br>be registered and compared. The influence of the distance measured on CT scan<br /><br>between the RSPV ostium and the right phrenic nerve on the incidence will be<br /><br>assessed.<br /><br><br /><br>3. The incidence of esophageal lesions for the three groups will be established<br /><br>with gastroendoscopy and compared. The influence of minimal luminal esophageal<br /><br>temperature (LET) and cryoballoon temperature, duration of cryoenergy<br /><br>application and mean LET decrease on the formation of thermal lesions will be<br /><br>evaluated. </p><br>