Cardioversion vs. Catheter Ablation for Persistent Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Randomized Study Comparing Cardioversion vs. Catheter Ablation in Patients With Persistent Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00196209
• Other study ID #: GE IDE No. C00705
• Status: Recruiting
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: March 18, 2008
• Start date: August 2005
• Est. completion date: December 2009

Study information

• Verified date: March 2008
• Source: Deutsches Herzzentrum Muenchen
• Contact: Heidi L Estner, MD
• Phone: 0049 89 1218 2020
• Email: estner[@]dhm.mhn.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• catheter ablation
catheter ablation to treat persistent atrial fibrillation
• external electric cardioversion
external cardioversion and drug prophylaxis to treat persistent atrial fibrillation

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum Muenchen	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		6 months	No
Secondary	success-rate immediately after intervention		success-rate immediately after intervention	No
Secondary	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)		2-3 months	No
Secondary	burden of atrial fibrillation in a 7-day-holter after 6 months		6 months	No
Secondary	significant improvement in exercise capacity (measured by spiroergometry)		6 months	No
Secondary	decrease in NT-pro-BNP levels in the blood after 6 months compared to the level before initial intervention		6 months	No
Secondary	improvement of quality-of-life (combined questionnaire including the SF-36 form) before initial intervention and at the 6-months follow-up		6 months	No