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Cardioversion vs. Catheter Ablation for Persistent Atrial Fibrillation

NCT ID: NCT00196209

Last Updated: 2008-03-19

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

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2009-12-31

Brief Summary

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The aim of this randomized study is to evaluate the efficacy of two different approaches for conversion of persistent atrial fibrillation, the non-invasive one (external electrical cardioversion) and the invasive one (catheter ablation).

Detailed Description

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This randomized study compares two treatment strategies in patients with persistent atrial fibrillation: Cardioversion vs. catheter ablation. Cardioversion is a low risk standard treatment option for patients with persistent atrial fibrillation. However, mid- and long term efficacy (regarding the maintenance of sinus rhythm) is low. Catheter ablation is an invasive treatment which has been reported to result in up to 60-70% of patients in stable sinus rhythm. However, it is a potentially dangerous invasive procedure with potentially fatal complications.

Comparison: External cardioversion vs. catheter ablation

Conditions

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Atrial Fibrillation

Keywords

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atrial fibrillation catheter ablation

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

catheter ablation to treat persistent atrial fibrillation

Group Type EXPERIMENTAL

catheter ablation

Intervention Type PROCEDURE

catheter ablation to treat persistent atrial fibrillation

2

cardioversion and drug prophylaxis to treat persistent atrial fibrillation

Group Type EXPERIMENTAL

external electric cardioversion

Intervention Type PROCEDURE

external cardioversion and drug prophylaxis to treat persistent atrial fibrillation

Interventions

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catheter ablation

catheter ablation to treat persistent atrial fibrillation

Intervention Type PROCEDURE

external electric cardioversion

external cardioversion and drug prophylaxis to treat persistent atrial fibrillation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age \>20 years and \<75 years
* documented persistent atrial fibrillation for at least 3 months (documented in at least 2 ECGs or holter-ECGs during the previous 3 months before inclusion and persistent atrial fibrillation in a 7-d-holter)
* documented sufficient anticoagulation for at least 4 weeks before inclusion

Exclusion Criteria

* Paroxysmal atrial fibrillation
* NYHA IV (if recompensation is not possible)
* Contraindication for warfarin
* Disturbance of blood coagulation
* Myocardial infarction, PTCA/stenting, bypass-operation, stroke, intracranial bleeding less than 3 months before
* Reversible causes of atrial fibrillation (i.e. hyperthyroidism)
* Pregnancy
* LA-diameter \> 55mm
* LV-function \< 30% EF
* Aortic or mitral stenosis or regurgitation III°-IV°
* Prosthetic valves
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 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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Isabel Deisenhofer, MD

Role: STUDY_CHAIR

Deutsches Herzzentrum Muenchen

Heidi L 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 L Estner, MD

Role: CONTACT

Phone: 0049 89 1218 2020

Email: [email protected]

Facility Contacts

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Heidi L. Estner, MD

Role: primary

Other Identifiers

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GE IDE No. C00705

Identifier Type: -

Identifier Source: org_study_id