Benefit of Left Atrial Roof Ablation in Paroxysmal Atrial Fibrillation

Phase 3

Completed

• Conditions: Drug-refractory Paroxysmal Atrial Fibrillation
• Interventions: Procedure: Pulmonary vein encircling; Procedure: Pulmonary vein encircling plus roof ablation

• 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

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2010-09-15
• Study First Submitted QC: 2010-09-15
• Study First Posted: 2010-09-16
• Primary Completion: 2011-12
• Study Completion: 2012-12
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-11
• Last Update Posted: 2013-12-12

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

Arm && Interventions

Group	Intervention	Description
Conventional ablation	Pulmonary vein encircling	Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum
Conventional ablation plus left atrial roof ablation	Pulmonary vein encircling plus 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.

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