Early Rhythm-Control Therapy and Risk Factor Management in Adults with Device-Detected Atrial High-Rate Episodes to Prevent Clinical Atrial Fibrillation Progression

What this Trial Is About

Atrial high-rate episodes AHREs detected by cardiac implantable electronic devices CIEDs signal an early stage of atrial fibrillation AF and are linked to a higher risk of progression to clinical AF, stroke, heart failure, and death. The best way to manage patients with AHREs lasting between 6 minutes and 24 hours is unclear. This study aims to evaluate whether combining early rhythm-control therapy with optimal risk factor management can reduce progression to sustained AHREs lasting 24 hours or more or clinical AF compared to usual care focusing on risk factor modification alone. Participants with CIED-detected AHREs between 6 minutes and 24 hours and no prior clinical AF diagnosis will be randomly assigned to one of two groups an early rhythm-control strategy group or a usual care group. The rhythm-control strategy may include antiarrhythmic drugs, catheter ablation, or other physician-directed interventions, alongside comprehensive cardiovascular risk factor management. The usual care group will receive standard clinical care and risk factor management according to guidelines. The study will follow participants for up to 36 months to assess outcomes. Throughout the study, participants will have regular device checks and clinical follow-ups. Researchers will measure progression to sustained AHRE or clinical AF as the primary outcome. Secondary outcomes include stroke, systemic embolism, heart failure hospitalization, cardiovascular death, and overall mortality. The study seeks to determine if early rhythm control can delay AHRE progression and improve long-term heart health in adults with device-detected AHREs.

The Clinical Outcomes and Therapeutic Effects in Patients With Cardiac Implantable Electronic Device-detected Subclinical and Clinical Atrial Fibrillation.