A comparison of whether catheter ablation improves the prognosis (all-cause mortality and/or the composite endpoint of MACE) and reduces the recurrence rate of atrial fibrillation (AF) in patients with AF and heart failure with preserved ejection fraction (HFpEF), compared to anti-atrial arrhythmia drugs (AAD). This trial was randomly divided into two groups: the anti-AAD drug group and the catheter ablation group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
304
Catheter ablation of atrial fibrillation
Shanghai Chest Hospital
Shanghai, China
The primary endpoint was a composite of all-cause death or rehospitalization for worsening HF.
The primary endpoint was a composite of all-cause death or rehospitalization for worsening HF.
Time frame: During regular follow-up visits at 3, 6, 12, 24months.
All-Cause Mortality
All deaths and all heart transplants because of terminal heart failure (HF) will be included.
Time frame: During regular follow-up visits at 3, 6, 12, 24months.
Worsening of Heart Failure Requiring Unplanned Hospitalization
Patients requiring intravenous medication for HF (including diuretics, vasodilators or inotropic agents) or a substantial increase in oral diuretic therapy for HF (i.e., an increase of furosemide ≥40 mg or equivalent, or the addition of a thiazide to a loop diuretic) will be deemed to have worsening of HF. Further, rales and/or S3 sound, chest x-ray, worsening of dyspnea, worsening of peripheral edema and increase of New York Heart Association class will be assessed for determination of worsening of HF.Unplanned hospitalization is defined as any in-hospital stay over one date change, and not planned by the Investigator.
Time frame: During regular follow-up visits at 3, 6, 12, 24months.
Cardiovascular Mortality
All deaths due to cardiovascular reasons and all heart transplants because of terminal HF. Deaths due to worsening of HF, acute coronary syndrome, cerebrovascular accidents, or other cardiovascular events will qualify for this secondary end point.
Time frame: During regular follow-up visits at 3, 6, 12, 24months.
Unplanned Hospitalization due to Cardiovascular Reason
Any in-hospital stay over one date change due to cardiovascular reason, which includes worsening of HF, acute coronary syndrome, cerebrovascular accidents, or other cardiovascular events, and not planned by the Investigator. In case the hospitalization is classified as planned by the Investigator, and the time interval between the decision to hospitalize and the hospitalization is less than 24 hours, the End Point and Adverse Event Committee will give final classification concerning planned or unplanned.
Time frame: During regular follow-up visits at 3, 6, 12, 24months.
All-Cause Hospitalization
Any in-hospital stay over one date change.
Time frame: During regular follow-up visits at 3, 6, 12, 24months.
Cerebrovascular Accident
Cerebrovascular accident, ischemic or hemorrhagic, describes a clinical and neurological syndrome, based on an acute damage of the brain. The common denominator is the sudden onset of a neurological deficit.
Time frame: During regular follow-up visits at 3, 6, 12, 24months.
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