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

NCT ID: NCT01229475

Last Updated: 2013-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Atrial Fibrillation Recurrence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stepwise approach

Stepwise approach for repeat AF ablation

Group Type ACTIVE_COMPARATOR

Ablation with stepwise approach

Intervention Type PROCEDURE

Stepwise approach for repeat AF ablation

Linear ablation

Intervention Type PROCEDURE

Linear ablation for AF ablation

Linear ablation

Linear ablation for repeat procedure in patients with recurrent atrial fibrillation

Group Type ACTIVE_COMPARATOR

Ablation with stepwise approach

Intervention Type PROCEDURE

Stepwise approach for repeat AF ablation

Linear ablation

Intervention Type PROCEDURE

Linear ablation for AF ablation

Interventions

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Ablation with stepwise approach

Stepwise approach for repeat AF ablation

Intervention Type PROCEDURE

Linear ablation

Linear ablation for AF ablation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role lead

Responsible Party

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Deutsches Herzzentrum München

Principal Investigators

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Isabel Deisenhofer, MD

Role: STUDY_CHAIR

Deutsches Herzzentrum München

Sonia Ammar, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum München

Locations

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Deutsches Herzzentrum München

Munich, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Sonia Ammar, MD

Role: CONTACT

+49891218 ext. 2020

Other Identifiers

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GER-EP-003

Identifier Type: -

Identifier Source: org_study_id

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