Atrial Fibrillation with Heart Failure with Preserved Ejection Fraction: Treatment Strategies-Catheter Ablation Vs. Anti-Atrial Arrhythmia Drugs

Atrial Fibrillation with Heart Failure with Preserved Ejection Fraction: Treatment Strategies-Catheter Ablation Vs. Anti-Atrial Arrhythmia Drugs

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.

Inclusion Criteria:

• 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.
• Diagnosed with Heart Failure with Preserved Ejection Fraction (HFpEF).（(1) a history of hospitalization for HF with symptoms classified as New York Heart Association (NYHA) class II, III, or IV; (2) LVEF ≥ 50%; (3) at least one of the following cardiac structural abnormalities identified by echocardiography: left ventricular hypertrophy, left atrial enlargement, or diastolic dysfunction; and (4) elevated levels of N-terminal pro-brain natriuretic peptide (NT-proBNP), with a threshold of ≥400 pg/mL for pa-tients with SR at admission and ≥600 pg/mL for patients with AF at admis-sion.)
• New York Heart Association class II, III, or IV.

Exclusion Criteria:

• 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.
• Planned cardiovascular intervention.
• Listed for heart transplant.
• Cardiac assist device implanted.
• Life expectancy ≤ 12 months.
• Mental or physical inability to participate in the study.
• Requirement for dialysis due to terminal renal failure.
• Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age.
• Enrollment in another investigational drug or device study, or participation in another telemonitoring concept.