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Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 14, 2026
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Phase 3 Trial.
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Registry record from ClinicalTrials.gov (NCT07238452). This is a study registration, not published results. Lead sponsor: University of British Columbia. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 1050 participants (ESTIMATED). Conditions: Heart Failure With Reduced Ejection Fraction, Atrial Fibrillation (AF). Interventions: DEVICE: Pulmonary Vein Isolation; DRUG: Pharmacological Rate Control. Primary outcome measures: Composite of time to first cardiovascular mortality, stroke, or heart failure event , 5 years. Brief summary: Atrial Fibrillation (AF) and Heart Failure (HF) are colliding global cardiovascular epidemics, individually impairing quality of life and cardiac performance, as well as increasing the risk of hospitalisation and mortality. When AF and HF co-exist, disease progression accelerates and the adverse outcomes are magnified, leading to incrementally higher morbidity, mortality, and healthcare expenditure. The management of AF is dichotomised into the restoration and maintenance of sinus rhythm ("Rhythm control") or acceptance of AF with control of the ventricular response ("Rate control"). Previous studies suggested that pharmacologic rhythm control and pharmacologic rate control confer similar survival and morbidity outcomes in patients with significant left ventricular dysfunction. Recognising the limitations of pharmacotherapy, more recent studies have examined the utility of catheter ablation procedures designed to restore and maintain sinus rhythm (e.g., catheter-based pulmonary vein isolation). Studies have suggested that catheter ablation procedures may provide sustained improvements in quality of life, decreased hospitalisation and, potentially, improved survival for patients with co-existing AF and HF, when compared to pharmacotherapy. However, significant limitations in these small trials have limited their impact on clinical practice. We propose a randomised controlled trial to definitively answer the question regarding the optimal treatment of AF in patients with heart failure with reduced ejection fraction (HFrEF), specifically aiming to determine if catheter ablation can reduce death, stroke, and heart failure events.