NCT06740539Not yet recruitingNot Applicable
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 enrollmentStarted: December 16, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- 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.
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Ablation Group
Experimental
Ablation Group: Received heart failure treatment combined with ablation
Intervention: Catheter ablation of atrial fibrillation (Procedure)
Drug Control Group
No Intervention
Received heart failure treatment combined with heart rate control.
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.)
Investigators
Xu Liu
Professor
Shanghai Chest Hospital
Study Sites (1)
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