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

Not Applicable

• Conditions: Atrial Fibrillation; Recurrence

• 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

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