Objective
The larger study is designed to determine whether an ablation-based rhythm-control strategy can reduce cardiovascular mortality and heart failure hospitalizations compared with rate control in this population.
Background
Atrial fibrillation and heart failure commonly occur together and can worsen one another. Patients with both conditions may experience more symptoms, more hospitalization and worse cardiovascular outcomes. Two commonly used approaches for managing AF are: • Rate control: medications are used to control how fast the heart beats while AF may continue. • Rhythm control: catheter ablation is used to try to restore and maintain a normal heart rhythm. Although catheter ablation and rate-control therapy are both established treatments, it is not yet known which strategy provides better long-term outcomes for people with AF and heart failure whose left ventricular ejection fraction is above 40%. Most previous trials have focused on patients with more severely reduced heart function. CABANA-RAFT HF therefore compares these two treatment strategies in patients with HFmrEF/HFpEF. Participants are randomly assigned, with an equal chance, to either ablation-based rhythm control or rate control.
Study Outcomes
Primary
- The primary purpose of the pilot study is to determine whether a larger trial is feasible. Feasibility will assess:
- • Participant recruitment
- • Treatment crossover
- • Completeness of study data at 12 months.
Secondary
- • Cardiovascular mortality
- • Heart failure hospitalization
- • All-cause mortality
- • Other cardiovascular hospitalizations or emergency department visits
- • Change in NT-proBNP
- • Change in left ventricular ejection fraction
- • Atrial fibrillation burden
- • Quality of life measured using EQ-5D, AFEQT and KCCQ-12
- • Change in 6-minute walk distance.
Eligibility Criteria
The criteria below are a summary. Your study doctor will confirm whether this study is right for you.
Inclusion Criteria
- • Age ≥18 years
- • Documented atrial fibrillation
- • NYHA Class II–III heart failure
- • LVEF >40%
- • LVEF assessment within the previous 12 months
- • Suitable for either catheter ablation-based rhythm control or rate-control therapy
- • Stable guideline-directed medical therapy for at least 1 month
- • Stable dose of diuretics for at least 2 weeks before randomization
- • Qualifying NT-proBNP.
Exclusion Criteria
- • Permanent AF
- • Previous catheter ablation for AF
- • NYHA Class IV heart failure
- • Rheumatic heart disease
- • Moderate or severe mitral stenosis
- • Mechanical mitral valve
- • Severe aortic stenosis
- • Severe aortic or mitral regurgitation
- • Renal failure requiring dialysis
- • Contraindication to oral anticoagulation
- • Infiltrative cardiomyopathy
- • Complex congenital heart disease
- • Untreated thyroid disease
- • Acute coronary syndrome or coronary artery bypass surgery within the previous 12 weeks
- • Participation in another clinical trial
- • Inability to provide informed consent
- • A non-cardiovascular medical condition making 1-year survival unlikely.
About taking part
If you would like to learn more about taking part in this study, please contact our research team using the details on this page. We can walk you through what participation involves and answer any questions.