Cardioversion vs. Catheter Ablation for Persistent Atrial Fibrillation

Last updated: March 18, 2008
Sponsor: Deutsches Herzzentrum Muenchen
Overall Status: Trial Status Unknown

Phase

4

Condition

Atrial Fibrillation

Chest Pain

Arrhythmia

Treatment

N/A

Clinical Study ID

NCT00196209
GE IDE No. C00705
  • Ages 20-75
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age >20 years and <75 years

  • documented persistent atrial fibrillation for at least 3 months (documented in atleast 2 ECGs or holter-ECGs during the previous 3 months before inclusion andpersistent atrial fibrillation in a 7-d-holter)

  • documented sufficient anticoagulation for at least 4 weeks before inclusion

Exclusion

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 bleedingless 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

Study Design

Total Participants: 130
Study Start date:
August 01, 2005
Estimated Completion Date:
December 31, 2009

Study 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

Connect with a study center

  • Deutsches Herzzentrum Muenchen

    Munich, 80636
    Germany

    Active - Recruiting

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