Line Versus Spot Ablation in Persistent Atrial Fibrillation

Phase 4

• Conditions: Atrial Fibrillation
• Interventions: Procedure: linear anatomically oriented ablations; Procedure: focal electrophysiological oriented ablations

• Registration Number: NCT00196157
• Lead Sponsor: Deutsches Herzzentrum Muenchen

Brief Summary

In this randomized study dealing with the ablative treatment of persistent atrial fibrillation, two ablation strategies are compared: a more anatomically guided linear ablation scheme versus an electrophysiological guided focal ablation strategy aiming at the electrical isolating of the pulmonary veins and ablating areas of fragmented intracardiac electrograms thought to maintain atrial fibrillation.

Detailed Description

This randomized study deals with two different ablative treatment strategies for persistent atrial fibrillation: a more anatomically guided linear ablation scheme with encircling of the ipsilateral pulmonary veins (PV), a left atrial roof line and an anterior line bridging the anterior mitral anulus to the ostium of the left superior PV versus an electrophysiological guided focal ablation strategy aiming at isolating, electrically, the PV and ablating areas of fragmented intracardiac electrograms thought to maintain atrial fibrillation.

Both ablation approaches contain isolation of the most common source of triggering foci, i.e., the pulmonary veins and additional modification of the substrate maintaining atrial fibrillation.

The study endpoint is a combined efficacy/safety analysis. Extensive follow-up with three-monthly 7 days holter ECG is provided.

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-19
• Study First Posted: 2005-09-20
• Primary Completion: 2008-05
• Study Completion: 2008-11
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-28
• Last Update Posted: 2009-05-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• age between 18 and 80 years
• symptomatic persistent (> 7 days lasting) atrial fibrillation
• at least one unsuccessful cardioversion or atrial fibrillation relapse in the first 3 months after cardioversion despite antiarrhythmic drug therapy
• oral anticoagulation (> 4 weeks prior to ablation)

Exclusion Criteria

• moderate to severe valvular heart disease
• congenital heart disease
• LV-EF < 35%
• reversible cause for atrial fibrillation (e.g., hyperthyreosis)
• prior left atrial ablation or Maze operation
• left atrial thrombus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	linear anatomically oriented ablations	linear lesions to ablate persistent atrial fibrillation
2	focal electrophysiological oriented ablations	focal electrophysiologically guided ablations to treat persistent atrial fibrillation

Primary Outcome Measures

Name	Time	Method
Sinus rhythm in follow-up	Sinus rhythm in follow-up

Trial Locations

Locations (1)

Deutsches Herzzentrum Muenchen; 🇩🇪 Munich, Germany