Status:
COMPLETED
Catheter Ablation Versus Medical Rate Control for Atrial Fibrillation in Patients With Heart Failure
Lead Sponsor:
Royal Brompton & Harefield NHS Foundation Trust
Conditions:
Atrial Fibrillation
Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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...
Detailed Description
Currently available evidence suggests that occurrence of AF in patients with heart failure (HF) leads to a decline in exercise tolerance, worsened quality of life, increased hospitalisation, and in ma...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00878384
Start Date
April 1 2009
End Date
July 1 2012
Last Update
July 12 2012
Active Locations (1)
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1
Royal Brompton & Harefield NHS Trust
London, United Kingdom, SW3 6NP