A FACT (Atrial Fibrillation ablation and AutonomiC modulation via Thoracoscopic Surgery). A randomized single center study to prospectively investigate the effect of ablation of the autonomic ganglia in addition to minimally invasive surgical isolation of the pulmonary veins in patients with atrial fibrillation.
Completed
- Conditions
- Atrial FibrillationFibrillation10007521
- Registration Number
- NL-OMON34819
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 275
Inclusion Criteria
Patients with paroxysmal or persistent atrial fibrillation, refractory to at least one antiarrhythmic drug, between 18 and 80 years of age and willing to participate in the study and the follow-up
Exclusion Criteria
Catheter treatment for atrial fibrillation within 4 months before inclusion, myocardial infarction within the previous 2 months, heart failure, stroke in the previous 6 months, refuse to take medication, severely enlarged left atrium.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint of the study is freedom of AF after one and two years<br /><br>after the procedure with or without the use of antiarrhythmic drugs. Freedom of<br /><br>AF is defined as the absence of documentation of AF on serial Holter recordings<br /><br>during follow up and on ECGs recorded outside the scope of the study. One<br /><br>single episode of <30 minutes is allowed. Patients complaints about<br /><br>palpitations without the documentation of AF is allowed.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoints include:<br /><br>1) Freedom of AF after one and two years after the procedure without the use of<br /><br>any antiarrhythmic drug. Definition of freedom of AF as above.<br /><br>2) Improvement of functional status as measured by the RAND 36 quality of life<br /><br>questionnaires</p><br>