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Cardioversion vs. Catheter Ablation for Persistent Atrial Fibrillation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Deutsches Herzzentrum Muenchen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00196209
First received: September 12, 2005
Last updated: March 18, 2008
Last verified: March 2008
History of Changes
  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 4

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:

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 October 16, 2012