Benefit of Left Atrial Roof Ablation in Paroxysmal Atrial Fibrillation
Phase 3
Completed
- Conditions
- Drug-refractory Paroxysmal Atrial Fibrillation
- Registration Number
- NCT01203241
- Lead Sponsor
- Hospital Clinic of Barcelona
- Brief Summary
The aim of the present study is to assess whether left atrial roof ablation adds any benefit in the arrhythmia-free probability after paroxysmal atrial fibrillation ablation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- Drug-refractory paroxysmal atrial fibrillation
Exclusion Criteria
- Hypo or hyperthyroidism
- Implantable defibrillation or pacemaker implanted
- Moderate or severe mitral valve disease or mitral prosthetic valve
- Ejection fraction less than 30%
- Left atrial anteroposterior diameter more than 50 mm.
- Previous atrial fibrillation ablation
- Left atrium thrombus
- Current infective disease or sepsis
- Pregnant women
- Current unstable angor
- Acute myocardial infarction in last 3 months
- Atrial fibrillation secondary to ionic disturbance, thyroids disease or secondary to any other reversible or non cardiovascular disease
- Reduced expectancy of life (less than 12 months)
- Patient participating in another clinical study that investigates a drug or device
- Psychologically unstable patient or denies to give informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Freedom from atrial arrhythmias without antiarrhythmic drugs 1-year follow-up
- Secondary Outcome Measures
Name Time Method Freedom from atrial arrhythmias with or without antiarrhythmic drugs 1-year follow-up Presence of any complications in the acute phase or during follow-up 1-year follow-up
Trial Locations
- Locations (1)
Hospital Clinic Universitari
🇪🇸Barcelona, Spain
Hospital Clinic Universitari🇪🇸Barcelona, Spain