Stepwise Approach Versus Linear Ablation in Patients With Recurrence of Persistent Atrial Fibrillation

Not Applicable

• Conditions: Atrial Fibrillation; Recurrence
• Interventions: Procedure: Ablation with stepwise approach; Procedure: Linear ablation

• Registration Number: NCT01229475
• Lead Sponsor: Deutsches Herzzentrum Muenchen

Brief Summary

Catheter ablation of persistent atrial fibrillation (AF) remains a challenging procedure. Even in experienced centres, repeat interventions are necessary in up to 70 of patients to achieve sinus rhythm at a long-term follow-up.

While there is a consensus to perform pulmonary vein isolation (PVI) as a cornerstone for the ablation of paroxysmal and persistent AF ablation, different additional ablation strategies are used to achieve a modification of the substrate that perpetuates the arrhythmia: linear lesions (anterior and roof lines) or ablation of complex fractionated atrial electrograms (CFAE). In the stepwise approach PVI, CFAE ablation and/or LL are combined according to the presenting arrhythmia during procedure.

The aim of the study is to determine whether there is a difference in terms of freedom from arrhythmia between a stepwise approach and a linear ablation for repeat procedure in patient with recurrence of persistent atrial fibrillation.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-26
• Study First Submitted QC: 2010-10-26
• Study First Posted: 2010-10-27
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-28
• Last Update Posted: 2013-03-01
• Primary Completion: 2013-10
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Patients with recurrence of symptomatic persistent atrial fibrillation after at least one ablation procedure,
• with the last ablation procedure at least 3 months ago.
• at least one unsuccessful attempt of antiarrhythmic drug
• oral anticoagulation for at least 4 weeks prior to ablation

Exclusion Criteria

• LA thrombus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Linear ablation	Ablation with stepwise approach	Linear ablation for repeat procedure in patients with recurrent atrial fibrillation
Linear ablation	Linear ablation	Linear ablation for repeat procedure in patients with recurrent atrial fibrillation
Stepwise approach	Ablation with stepwise approach	Stepwise approach for repeat AF ablation
Stepwise approach	Linear ablation	Stepwise approach for repeat AF ablation

Primary Outcome Measures

Name	Time	Method
Freedom from atrial arrhythmia		Documented freedom from atrial arrhythmia (AF or AT) during follow-up.

Secondary Outcome Measures

Name	Time	Method
Procedural and safety data		1. Duration of left atrial procedure, ablation time, fluoroscopy time.; 2. Complications; 3. Type of recurrent arrhythmia; 4. Number of reablation

Trial Locations

Locations (1)

Deutsches Herzzentrum München; 🇩🇪 Munich, Germany