Identification of a Risk Profile Associated with Failure of the Cryoballoon Ablation of Atrial Fibrillation; a Multicenter Explorative Registry.
Recruiting
- Conditions
- Atrial Fibrillation10007521
- Registration Number
- NL-OMON46840
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 600
Inclusion Criteria
1. Patients who have agreed to undergo the cryoballoon ablation procedure for atrial fibrillation.
2. Age >18 years.
3. Written informed consent.
Exclusion Criteria
1. Patients who had a prior ablation treatment because of atrial fibrillation.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective is to assess a risk profile, including circulating<br /><br>biomarkers and genetic background, associated with failure of the cryoballoon<br /><br>AF ablation, i.e. any (a)symptomatic AF/AFL/AT >30 sec without anti-arrhythmic<br /><br>drugs determined within 1 year of follow-up by ECG recording and 1-day Holter<br /><br>monitoring.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes concern the identification of a risk profile associated with<br /><br>(long term) failure or success of the procedure; the number of patients<br /><br>requiring repeat baltaion following cryoballoon AF ablation; the<br /><br>electrophysiological findings during the (redo) procedure; procedural<br /><br>predictors of succes of the cryoballoon AF ablation; the incidence and type of<br /><br>supraventricular tachyarrhythmia*s following the procedure; the occurence of<br /><br>major cardiac and cardiovascular events; safety of the cryoballoon AF ablation;<br /><br>changes in left atrial size and function following ablation; the degree of<br /><br>epicardial adipose tissue; the use of anti-arrhythmic drugs; the frequency of<br /><br>repeated ablations; quality of life and physical activity.</p><br>