About the Study
Understanding the design, rationale, and scientific foundation behind a randomized controlled trial of catheter ablation for atrial fibrillation in heart failure with preserved ejection fraction.
Understanding the design, rationale, and scientific foundation behind a randomized controlled trial of catheter ablation for atrial fibrillation in heart failure with preserved ejection fraction.
Heart failure with preserved ejection fraction (HFpEF) affects an estimated 30–40% of the 5–6 million Americans living with heart failure. Among these patients, roughly 30% develop atrial fibrillation (AF)—a combination that carries a 25–60% rate of cardiovascular events and profoundly diminishes quality of life.
A subgroup analysis from the landmark CABANA trial demonstrated a striking 36% reduction in the primary endpoint among patients with heart failure. However, this finding was post-hoc and hypothesis-generating. To date, there are no completed randomized clinical trials evaluating whether catheter ablation improves outcomes in patients with both AF and HFpEF. Current guidelines acknowledge this gap, citing clinical equipoise and the urgent need for definitive evidence.
CABANA-HF was designed to close that evidence gap once and for all.
CABANA-HF is a prospective, randomized, open-label, parallel-arm multicenter trial. Patients are randomized 1:1 to one of two treatment strategies with a 3-month blanking period following ablation.
CABANA-HF uses a rigorous set of primary and secondary endpoints to capture the full spectrum of clinical benefit.
Composite of cardiovascular mortality or first worsening heart failure event, analyzed as time-to-first-event. This pragmatic, patient-centered endpoint reflects the outcomes that matter most.
Death attributable to cardiovascular causes, adjudicated by an independent, blinded clinical events committee.
Recurrent worsening HF events including hospitalizations, urgent visits, and intensification of diuretic therapy.
Death from any cause, providing an unbiased assessment of overall survival benefit.
Freedom from atrial fibrillation recurrence and quantitative AF burden assessed through continuous rhythm monitoring.
Comprehensive health-economic analysis comparing total costs and quality-adjusted life years between treatment arms.
Patient-reported outcomes measured by KCCQ, AFEQT, MAFSI, and EQ-5D-5L instruments at serial time points.
Procedural and treatment-related adverse events tracked systematically to ensure a complete safety profile.
CABANA-HF enrolls patients with both atrial fibrillation and heart failure with preserved ejection fraction who meet the following criteria.
Atrial Fibrillation
HFpEF / HFmrEF
From protocol finalization through results publication, CABANA-HF follows a rigorous multi-year timeline.
Participants are seen in clinic at 3, 6, and 12 months after randomization, then every 6 months thereafter through the end of the study. Each visit includes clinical assessment, medication review, adverse event monitoring, and patient-reported outcome questionnaires.
Continuous and serial rhythm monitoring ensures accurate AF burden assessment across both arms. During the first year, patients undergo monthly 24-hour Holter monitoring. Quarterly extended rhythm patches provide longer-duration surveillance. All participants receive an AliveCor KardiaMobile device for daily single-lead ECG recordings over the first 2 years. In addition, the Boston Scientific BodyGuardian Mini wearable biosensor enables continuous, clinical-grade rhythm monitoring to capture asymptomatic AF episodes and precisely quantify AF burden.
Our team is ready to provide additional information about the CABANA-HF trial design, eligibility criteria, or how to get involved.
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