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

Shanghai Chest Hospital1 site in 1 country304 target enrollmentDecember 16, 2024

ConditionsHFpEF - Heart Failure with Preserved Ejection Fraction Atrial Fibrillation (AF)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: HFpEF - Heart Failure with Preserved Ejection Fraction
Sponsor: Shanghai Chest Hospital
Enrollment: 304
Locations: 1
Primary Endpoint: The primary endpoint was a composite of all-cause death or rehospitalization for worsening HF.
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 16, 2024

End Date

January 1, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai Chest Hospital

Responsible Party

Principal Investigator

Xu Liu

Professor

Shanghai Chest Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

The primary endpoint was a composite of all-cause death or rehospitalization for worsening HF.

Secondary Outcomes

All-Cause Mortality(During regular follow-up visits at 3, 6, 12, 24months.)
Worsening of Heart Failure Requiring Unplanned Hospitalization(During regular follow-up visits at 3, 6, 12, 24months.)
Cardiovascular Mortality(During regular follow-up visits at 3, 6, 12, 24months.)
Unplanned Hospitalization due to Cardiovascular Reason(During regular follow-up visits at 3, 6, 12, 24months.)
All-Cause Hospitalization(During regular follow-up visits at 3, 6, 12, 24months.)
Cerebrovascular Accident(During regular follow-up visits at 3, 6, 12, 24months.)