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Stepwise Approach Versus Linear Ablation in Patients With Recurrence of Persistent Atrial Fibrillation (REDO-AF)

Primary Purpose

Atrial Fibrillation, Recurrence

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Ablation with stepwise approach

Linear ablation

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, recurrence, repeat procedure, linear ablation, stepwise approach

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Deutsches Herzzentrum MünchenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Stepwise approach

Linear ablation

Arm Description

Stepwise approach for repeat AF ablation

Linear ablation for repeat procedure in patients with recurrent atrial fibrillation

Outcomes

Primary Outcome Measures

Freedom from atrial arrhythmia

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

Secondary Outcome Measures

Procedural and safety data

Duration of left atrial procedure, ablation time, fluoroscopy time. Complications Type of recurrent arrhythmia Number of reablation

Full Information

NCT ID

NCT01229475

First Posted

October 26, 2010

Last Updated

February 28, 2013

Sponsor

Deutsches Herzzentrum Muenchen

1. Study Identification

Unique Protocol Identification Number

NCT01229475

Brief Title

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

Acronym

REDO-AF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Unknown status

Study Start Date

October 2010 (undefined)

Primary Completion Date

October 2013 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Deutsches Herzzentrum Muenchen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Recurrence

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Stepwise approach

Arm Type

Active Comparator

Arm Description

Stepwise approach for repeat AF ablation

Arm Title

Linear ablation

Arm Type

Active Comparator

Arm Description

Linear ablation for repeat procedure in patients with recurrent atrial fibrillation

Intervention Type

Procedure

Intervention Name(s)

Ablation with stepwise approach

Intervention Description

Stepwise approach for repeat AF ablation

Intervention Type

Procedure

Intervention Name(s)

Linear ablation

Intervention Description

Linear ablation for AF ablation

Primary Outcome Measure Information:

Title

Freedom from atrial arrhythmia

Description

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

Secondary Outcome Measure Information:

Title

Procedural and safety data

Description

Duration of left atrial procedure, ablation time, fluoroscopy time. Complications Type of recurrent arrhythmia Number of reablation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sonia Ammar, MD

Phone

+49891218

Ext

2020

ammar@dhm.mhn.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Isabel Deisenhofer, MD

Organizational Affiliation

Deutsches Herzzentrum München

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Sonia Ammar, MD

Organizational Affiliation

Deutsches Herzzentrum München

Official's Role

Principal Investigator

Facility Information:

Facility Name

Deutsches Herzzentrum München

City

Munich

ZIP/Postal Code

80636

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sonia Ammar, MD

12. IPD Sharing Statement

Learn more about this trial

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

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