Cardioversion vs. Catheter Ablation for Persistent Atrial Fibrillation - Full Text View

Sponsor:	Deutsches Herzzentrum Muenchen
Information provided by:	Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:	NCT00196209

Purpose

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).

Condition	Intervention	Phase
Atrial Fibrillation	Procedure: catheter ablation Procedure: external electric cardioversion	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized Study Comparing Cardioversion vs. Catheter Ablation in Patients With Persistent Atrial Fibrillation

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:

Event-free survival after 6 months (i.e. freedom of atrial tachyarrhythmias - as evaluated in a 7-d-holter, stroke, pulmonary vein stenosis - as evaluated in a CT-/MRT-scan 6 months after the initial procedure - and death). [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

success-rate immediately after intervention [ Time Frame: success-rate immediately after intervention ] [ Designated as safety issue: No ]
need for re-intervention between 2 and 3 months after initial procedure if not stable sinus rhythm at the two-months follow-up (further ablation/cardioversion) [ Time Frame: 2-3 months ] [ Designated as safety issue: No ]
burden of atrial fibrillation in a 7-day-holter after 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
significant improvement in exercise capacity (measured by spiroergometry) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
decrease in NT-pro-BNP levels in the blood after 6 months compared to the level before initial intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
improvement of quality-of-life (combined questionnaire including the SF-36 form) before initial intervention and at the 6-months follow-up [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	130
Study Start Date:	August 2005
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 catheter ablation to treat persistent atrial fibrillation	Procedure: catheter ablation catheter ablation to treat persistent atrial fibrillation
Experimental: 2 cardioversion and drug prophylaxis to treat persistent atrial fibrillation	Procedure: external electric cardioversion external cardioversion and drug prophylaxis to treat persistent atrial fibrillation

Detailed Description:

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

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196209

Contacts

Contact: Heidi L Estner, MD

0049 89 1218 2020

estner@dhm.mhn.de

Locations

Germany
Deutsches Herzzentrum Muenchen	Recruiting
Munich, Germany, 80636
Contact: Heidi L. Estner, MD 0049 89 1218-2020 estner@dhm.mhn.de
Principal Investigator: Heidi L Estner, MD

Sponsors and Collaborators

Deutsches Herzzentrum Muenchen

Investigators

Study Chair:	Isabel Deisenhofer, MD	Deutsches Herzzentrum Muenchen
Principal Investigator:	Heidi L Estner, MD	Deutsches Herzzentrum Muenchen

More Information

No publications provided

Responsible Party:	Prof. A. Schömig, Deutsches Herzzentrum Munich
ClinicalTrials.gov Identifier:	NCT00196209 History of Changes
Other Study ID Numbers:	GE IDE No. C00705
Study First Received:	September 12, 2005
Last Updated:	March 18, 2008
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Deutsches Herzzentrum Muenchen:

atrial fibrillation
catheter ablation

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012