Status:
COMPLETED
Benefit of Left Atrial Roof Ablation in Paroxysmal Atrial Fibrillation
Lead Sponsor:
Hospital Clinic of Barcelona
Conditions:
Drug-refractory Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- Drug-refractory paroxysmal atrial fibrillation
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01203241
Start Date
June 1 2009
End Date
December 1 2012
Last Update
December 12 2013
Active Locations (1)
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1
Hospital Clinic Universitari
Barcelona, Barcelona, Spain, 08036