Catheter Ablation Versus Medical Rate Control for Atrial Fibrillation in Patients With Heart Failure

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

It is still uncertain what the best treatment is for patients who have both atrial fibrillation (AF) and heart failure. The aim of the study is to help identify the optimal treatment for patients with these two significant medical conditions. This will be performed by comparing two alternative strategies for AF management: catheter ablation (to restore normal rhythm) and medical therapy (to control heart rate, but not aiming ro restore normal rhythm). After random assignment, the effect of each strategy will be assessed by looking for changes in exercise capacity, symptoms, heart pump function, and quality of life during 12 months of follow-up.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust

Criteria

Inclusion criteria:

• Age ≥ 18 years, < 80years

• NYHA II-IV symptoms

• Impairment of left ventricular systolic function (left ventricular ejection fraction estimated as ≤ 35% by radionuclide ventriculography)

• Documented AF lasting for at least 7 days (persistent or permanent AF)

Exclusion criteria:

• CRT or ICD device implanted in the previous 6 months

• AV nodal ablation within previous 3 months

• Prior AV nodal ablation or complete heart block with a single chamber pacemaker

• Contraindication to anticoagulation

• Persistent thrombus in the left atrium despite anticoagulation

• Active malignancy

• Cerebrovascular accident within the previous 6 months

• Reversible causes of AF including thyroid disorders, alcohol, recent surgery

• Reversible causes of heart failure including acute myocarditis or alcohol

• Cardiac events including myocardial infarction (MI), percutaneous coronary intervention (PCI), valve or coronary bypass surgery within the previous 3 months

• Prior AF ablation procedure

• Previous heart transplant, or on urgent heart transplant waiting list

• Severe neuro-muscular disease

• Creatinine clearance <30 ml/min

• Serum bilirubin >50 micromol/L

• Active participation in another research study

• Unable to understand and comply with protocol or give written informed consent

• Body mass index >35 (kg/m2)