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

Shanghai Jiao Tong University

Status

Not yet enrolling

Conditions

Atrial Fibrillation (AF)

HFpEF - Heart Failure with Preserved Ejection Fraction

Treatments

Procedure: Catheter ablation of atrial fibrillation

Study type

Interventional

Funder types

Other

Identifiers

NCT06740539

CAPHF-AF

Details and patient eligibility

About

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.

Enrollment

304 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.