Atrial Fibrillation, Heart Failure
Conditions
Keywords
Atrial fibrillation, Heart failure, Catheter ablation
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.
Interventions
PROCEDURECatheter ablation of persistent atrial fibrillation
Catheter ablation of AF as described previously by our group (e.g. Hunter et al, Heart 2010).
Medical treatment of persistent AF as 'normal care'. 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).
Sponsors
British Heart Foundation
Barts & The London NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Persistent atrial fibrillation * Symptomatic heart failure
Exclusion criteria
* Reversible causes of heart failure * Contraindications to catheter ablation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in ejection fraction between groups | 6 months | Difference in left ventricular ejection fraction between groups on echocardiography at 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in NYHA class between groups | 6 months | — |
| Difference in BNP between groups | 6 months | — |
| Difference in peak VO2 between groups | 6 months | — |
| Reduction in end systolic volume | 6 months compared to baseline | Comparisson between groups of the percentage reduction in left ventricular end systolic volume at 6 months compared to baseline. |
| Difference in heart failure symptoms | 6 months | Comparisson between groups in heart failure symptoms using the Minessota living with heart failure questionaire. |
| Difference in Quality of Life between groups | 6 months | Using SF36 and Minnessota questionaire |
Countries
United Kingdom
Contacts
Primary ContactRoss J Hunter, MRCP
Outcome results
None listed