Benefit of Left Atrial Roof Ablation in Paroxysmal Atrial Fibrillation
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Hospital Clinic of Barcelona
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Freedom from atrial arrhythmias without antiarrhythmic drugs
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Conventional ablation
Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum
Intervention: Pulmonary vein encircling (Procedure)
Conventional ablation plus left atrial roof ablation
Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum plus creation of a radiofrequency line joining contralateral superior pulmonary veins throughout the left atrial roof.
Intervention: Pulmonary vein encircling plus roof ablation (Procedure)
Outcomes
Primary Outcomes
Freedom from atrial arrhythmias without antiarrhythmic drugs
Time Frame: 1-year follow-up
Secondary Outcomes
- 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)
Investigators
Josep Lluis Mont Girbau
Head of the Arrhythmia Unit
Hospital Clinic of Barcelona