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

NCT01229475 | Unknown

• 1 other identifier: GER-EP-003
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Recurrence

Keywords

Atrial fibrillation; recurrence; repeat procedure; linear ablation; stepwise approach

Outcome Measures

Primary Outcomes (1)

• Freedom from atrial arrhythmia

  Documented freedom from atrial arrhythmia (AF or AT) during follow-up.

Secondary Outcomes (1)

• Procedural and safety data

Study Arms (2)

Stepwise approach

ACTIVE COMPARATOR

Stepwise approach for repeat AF ablation

Procedure: Ablation with stepwise approach; Procedure: Linear ablation

Linear ablation

ACTIVE COMPARATOR

Linear ablation for repeat procedure in patients with recurrent atrial fibrillation

Procedure: Ablation with stepwise approach; Procedure: Linear ablation

Interventions

Ablation with stepwise approach PROCEDURE

Stepwise approach for repeat AF ablation

Linear ablation; Stepwise approach

Linear ablation PROCEDURE

Linear ablation for AF ablation

Linear ablation; Stepwise approach

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• LA thrombus

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead

Study Sites (1)

Deutsches Herzzentrum München

Munich, 80636, Germany

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Recurrence

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Isabel Deisenhofer, MD

  Deutsches Herzzentrum München

  STUDY CHAIR

• Sonia Ammar, MD

  Deutsches Herzzentrum München

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonia Ammar, MD

CONTACT

+49891218; ammar@dhm.mhn.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 26, 2010
• First Posted: October 27, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 1, 2013

Record last verified: 2013-02

Locations

DE (1)