Line Versus Spot Ablation in Persistent Atrial Fibrillation

German Heart Center Munich

Status and phase: Unknown; Phase 4

Conditions: Atrial Fibrillation

Treatments: Procedure: linear anatomically oriented ablations; Procedure: focal electrophysiological oriented ablations

Study type: Interventional

Funder types: Other

Identifiers

NCT00196157

GE IDE No. C00604

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

1

Experimental group

Description:

linear lesions to ablate persistent atrial fibrillation

Treatment:

Procedure: linear anatomically oriented ablations

2

Experimental group

Description:

focal electrophysiologically guided ablations to treat persistent atrial fibrillation

Treatment:

Procedure: focal electrophysiological oriented ablations