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Clinical Trials/NCT01411371
NCT01411371
Unknown
Not Applicable

Catheter Ablation Versus Medical Treatment of AF in Heart Failure

Barts & The London NHS Trust1 site in 1 country60 target enrollmentMarch 2005

Overview

Phase
Not Applicable
Intervention
Catheter ablation of persistent atrial fibrillation
Conditions
Atrial Fibrillation
Sponsor
Barts & The London NHS Trust
Enrollment
60
Locations
1
Primary Endpoint
Difference in ejection fraction between groups
Last Updated
14 years ago

Overview

Brief Summary

Heart failure and atrial fibrillation (AF) often coexist, and each increases the morbidity and mortality associated with the other. The investigators hypothesized that restoration of normal sinus rhythm by catheter ablation is superior to medical treatment of AF in heart failure. This study randomizes patients with heart failure and persistent AF to medical treatment of AF or catheter ablation to restore sinus rhythm.

Registry
clinicaltrials.gov
Start Date
March 2005
End Date
October 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Persistent atrial fibrillation
  • Symptomatic heart failure

Exclusion Criteria

  • Reversible causes of heart failure
  • Contraindications to catheter ablation

Arms & Interventions

Catheter Ablation

Catheter ablation of persistent atrial fibrillation to restore normal sinus rhythm.

Intervention: Catheter ablation of persistent atrial fibrillation

Medical treatment alone

Patients are randomised to medical treatment alone for atrial fibrillation. Treatment will be as per current guidelines for persistent atrial fibrillation, with rate control as first line (using beta-blockers, calcium channel blockers and digoxin as indicated) and rhythm control as second line (using sotalol, dronedarone, or amiodarone as indicated). (Both groups will receive standard heart failure medication including angiotensin converting enzyme inhibitors, beta blockers, aldosterone antagonists, and diuretics as indicated).

Intervention: Medical treatment alone

Outcomes

Primary Outcomes

Difference in ejection fraction between groups

Time Frame: 6 months

Difference in left ventricular ejection fraction between groups on echocardiography at 6 months

Secondary Outcomes

  • Difference in peak VO2 between groups(6 months)
  • Difference in NYHA class between groups(6 months)
  • Difference in BNP between groups(6 months)
  • Difference in Quality of Life between groups(6 months)
  • Reduction in end systolic volume(6 months compared to baseline)
  • Difference in heart failure symptoms(6 months)

Study Sites (1)

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