Cardioversion vs. Catheter Ablation for Persistent Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00196209
Recruitment Status : Unknown
Verified March 2008 by Deutsches Herzzentrum Muenchen.
Recruitment status was:  Recruiting
First Posted : September 20, 2005
Last Update Posted : March 19, 2008
Information provided by:
Deutsches Herzzentrum Muenchen

Brief Summary:
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 or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: catheter ablation Procedure: external electric cardioversion Phase 4

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Study Comparing Cardioversion vs. Catheter Ablation in Patients With Persistent Atrial Fibrillation
Study Start Date : August 2005
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. success-rate immediately after intervention [ Time Frame: success-rate immediately after intervention ]
  2. 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 ]
  3. burden of atrial fibrillation in a 7-day-holter after 6 months [ Time Frame: 6 months ]
  4. significant improvement in exercise capacity (measured by spiroergometry) [ Time Frame: 6 months ]
  5. decrease in NT-pro-BNP levels in the blood after 6 months compared to the level before initial intervention [ Time Frame: 6 months ]
  6. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00196209

Contact: Heidi L Estner, MD 0049 89 1218 2020

Deutsches Herzzentrum Muenchen Recruiting
Munich, Germany, 80636
Contact: Heidi L. Estner, MD    0049 89 1218-2020   
Principal Investigator: Heidi L Estner, MD         
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Study Chair: Isabel Deisenhofer, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Heidi L Estner, MD Deutsches Herzzentrum Muenchen

Responsible Party: Prof. A. Schömig, Deutsches Herzzentrum Munich Identifier: NCT00196209     History of Changes
Other Study ID Numbers: GE IDE No. C00705
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 19, 2008
Last Verified: March 2008

Keywords provided by Deutsches Herzzentrum Muenchen:
atrial fibrillation
catheter ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes