To investigate whether RFCA is superior to AADs in AF patients with HFpEF on the basis of optimized anti-heart-failure drug therapy regarding their longterm clinical outcomes.
Symptomatic paroxysmal or persistent atrial fibrillation
CHADS2-VASc score≥ 2
Conform to the diagnosis of HFpEF
NYHA II-IV level;
A life expectancy below 2 years due to any non-cardiovascular condition
Reversible atrial fibrillation, such as hyperthyroidism or hypokalemia-related atrial fibrillation
Prior atrial fibrillation ablation
Left atrial size≥ 55 mm
Parallel
Radiofrequency catheter ablation (RFCA)
Procedure/SurgeryRadiofrequency ablation is adopted in the study, instead of cryo ablation, surgical ablation or pulsed field ablation. 3-dimensional model is constructed after transseptal puncture. Circumferential pulmonary vein isolation (CPVI) is performed with irrigated contact force catheter. Previously published STABLE-SR approach is recommended as the ablation strategy beyond CPVI.
Medical Therapy
DrugAADs should be prescribed according to the current guidelines, such as amiodarone, dronedarone, or propafenone. In brief, rhythm control is preferred, including electric cardioversion. However, rate control should be considered if rhythm control is contraindicated, intolerated or unpreferred by patients.
Composite endpoint of worsening heart failure requiring unplanned hospitalizations or urgent visits, and cardiovascular death (Time-to-first event analysis)
Time to hospitalization or urgent visits for heart failure
Worsening heart failure includes worsening heart failure requiring unplanned hospitalization and worsening heart failure requiring urgent visits.
Time to hospitalization for heart failure
In addition to signs and symptoms of HF, the patient should also receive treatment specifically directed at HF, including at least 1 of the following: 1) significant augmentation in oral diuretic therapy; 2) initiation of intravenous diuretic (even a single dose) or vasoactive agent (eg, vasodilator, vasopressor, or inotropic therapy); or 3) mechanical circulatory support or fluid removal. Unplanned hospitalization is defined as any unscheduled hospital admission with a length of stay that either exceeds 24 h or crosses a calendar day, and not planned by the investigators. In case the hospitalization is classified as planned by the Investigator and the time interval between the decision to admit and the admission is less than 24 hours, the End Point and Adverse Event Committee will give final classification concerning planned or unplanned.
Time to urgent visits for heart failure
Worsening of Heart Failure Requiring Unplanned Urgent Visits Patients have an urgent, unscheduled office or emergency visit for HF with signs, symptoms, and diagnostic testing results identical to those already described for an HF hospitalization. The patient must also (with the exception of significant augmentation in oral diuretic therapy) require therapy similar to that previously described for an HF hospitalization.
Time to cardiovascular death
All deaths due to cardiovascular reasons and all heart transplants because of terminal HF. Deaths due to worsening of HF, acute coronary syndrome, cerebrovascular accident.
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