Repeat Ablation Procedure in Patients With Relapse of Atrial Fibrillation

NCT ID: NCT01229306

Last Updated: 2013-05-03

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

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2014-01-31

Brief Summary

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Catheter ablation with isolation of the pulmonary veins has proven to be an effective treatment option in patients with paroxysmal atrial fibrillation. In patients who have a relapse of paroxysmal atrial fibrillation after one ablation procedure the investigators compare the reisolation of all pulmonary veins to reisolation plus an anterior left atrial line.

Detailed Description

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Catheter ablation with isolation of the pulmonary veins has proven to be an effective treatment option in patients with paroxysmal atrial fibrillation. In patients who have a relapse of paroxysmal atrial fibrillation after one ablation procedure we compare the reisolation of all pulmonary veins to reisolation plus an anterior left atrial line.

Conditions

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Ablation Paroxysmal 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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reisolation of all PV and additional anterior line

Group Type EXPERIMENTAL

Ablation

Intervention Type PROCEDURE

Ablation of atrial fibrillation

reisolation of all pulmonary veins

Group Type PLACEBO_COMPARATOR

Ablation

Intervention Type PROCEDURE

Ablation of atrial fibrillation

Interventions

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Ablation

Ablation of atrial fibrillation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* relapse of atrial fibrillation

Exclusion Criteria

* contraindication for ablation
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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Abteilung Elektrophysiologie

Locations

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Deutsches Herzzentrum

München, Bayer, Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Isabel Deisenhofer, MD

Role: primary

+49891218 ext. 4596

Stephanie Fichtner, MD

Role: backup

+49891218 ext. 4596

Other Identifiers

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GER-EP-002

Identifier Type: -

Identifier Source: org_study_id

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