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.
Age ≥18 years.
The patient is willing and able to comply with the protocol and has provided written informed consent.
Paroxysmal or persistent atrial fibrillation (AF).（Persistent AF was defined as AF which is sustained beyond 7 days, or lasting less than seven days but necessitating pharmacologic or electric cardioversion. Included within the category of persistent AF is 'long-standing persistent AF', defined as continuous AF of >1-year duration. AF episodes had to be documented in the last 3 months prior to enrollment by ECG, Holter ECG, Loop Recorder, memory of the implanted device (ICD/CRT-D), or any other suitable device.）
Failure or intolerance of antiarrhythmic drug therapy or unwillingness to take antiarrhythmic drugs.
Previous left heart ablation procedure for AF.
Contraindication to chronic anticoagulation therapy or heparin.
Documented left atrial diameter >6 cm, optimally from the parasternal long-axis view.
Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 2 months prior to enrollment.
Parallel
Catheter ablation of atrial fibrillation
Procedure/SurgeryCatheter ablation of atrial fibrillation
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.
All-Cause Mortality
All deaths and all heart transplants because of terminal heart failure (HF) will be included.
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.
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.
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.
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Shanghai Chest Hospital
Lead sponsor
The Third Affiliated Hospital of Anhui Medical University
Collaborator
Hefei Second People's Hospital
Collaborator
The Second People's Hospital of Anhui Province
Collaborator
Hefei Binhu Hospital
Collaborator
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