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

Atrial Fibrillation Clinical Trial

— REDO-AF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01229475
• Other study ID #: GER-EP-003
• Status: Recruiting
• Phase: N/A
• First received: October 26, 2010
• Last updated: February 28, 2013
• Start date: October 2010
• Est. completion date: December 2013

Study information

• Verified date: February 2013
• Source: Deutsches Herzzentrum Muenchen
• Contact: Sonia Ammar, MD
• Phone: +49891218
• Email: ammar[@]dhm.mhn.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Recurrence

Intervention

Procedure:
• Ablation with stepwise approach
Stepwise approach for repeat AF ablation
• Linear ablation
Linear ablation for AF ablation

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum München	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from atrial arrhythmia	Documented freedom from atrial arrhythmia (AF or AT) during follow-up.		No
Secondary	Procedural and safety data	Duration of left atrial procedure, ablation time, fluoroscopy time.; Complications; Type of recurrent arrhythmia; Number of reablation		Yes