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Line Versus Spot Ablation in Persistent Atrial Fibrillation

NCT ID: NCT00196157

Last Updated: 2009-05-29

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

PHASE4

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2008-11-30

Brief Summary

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In this randomized study dealing with the ablative treatment of persistent atrial fibrillation, two ablation strategies are compared: a more anatomically guided linear ablation scheme versus an electrophysiological guided focal ablation strategy aiming at the electrical isolating of the pulmonary veins and ablating areas of fragmented intracardiac electrograms thought to maintain atrial fibrillation.

Detailed Description

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This randomized study deals with two different ablative treatment strategies for persistent atrial fibrillation: a more anatomically guided linear ablation scheme with encircling of the ipsilateral pulmonary veins (PV), a left atrial roof line and an anterior line bridging the anterior mitral anulus to the ostium of the left superior PV versus an electrophysiological guided focal ablation strategy aiming at isolating, electrically, the PV and ablating areas of fragmented intracardiac electrograms thought to maintain atrial fibrillation.

Both ablation approaches contain isolation of the most common source of triggering foci, i.e., the pulmonary veins and additional modification of the substrate maintaining atrial fibrillation.

The study endpoint is a combined efficacy/safety analysis. Extensive follow-up with three-monthly 7 days holter ECG is provided.

Conditions

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Atrial Fibrillation

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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1

linear lesions to ablate persistent atrial fibrillation

Group Type EXPERIMENTAL

linear anatomically oriented ablations

Intervention Type PROCEDURE

linear lesions to ablate persistent atrial fibrillation

2

focal electrophysiologically guided ablations to treat persistent atrial fibrillation

Group Type EXPERIMENTAL

focal electrophysiological oriented ablations

Intervention Type PROCEDURE

focal electrophysiologically guided ablations to treat persistent atrial fibrillation

Interventions

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linear anatomically oriented ablations

linear lesions to ablate persistent atrial fibrillation

Intervention Type PROCEDURE

focal electrophysiological oriented ablations

focal electrophysiologically guided ablations to treat persistent atrial fibrillation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age between 18 and 80 years
* symptomatic persistent (\> 7 days lasting) atrial fibrillation
* at least one unsuccessful cardioversion or atrial fibrillation relapse in the first 3 months after cardioversion despite antiarrhythmic drug therapy
* oral anticoagulation (\> 4 weeks prior to ablation)

Exclusion Criteria

* moderate to severe valvular heart disease
* congenital heart disease
* LV-EF \< 35%
* reversible cause for atrial fibrillation (e.g., hyperthyreosis)
* prior left atrial ablation or Maze operation
* left atrial 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 Munich

Principal Investigators

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Claus Schmitt, MD

Role: STUDY_CHAIR

Deutsches Herzzentrum Muenchen

Heidi Estner, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum Muenchen

Locations

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Deutsches Herzzentrum Muenchen

Munich, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Heidi Estner, MD

Role: CONTACT

Phone: 0049 89 1218 2020

Email: [email protected]

Facility Contacts

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Heidi Estner, MD

Role: primary

Other Identifiers

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GE IDE No. C00604

Identifier Type: -

Identifier Source: org_study_id