Clinical trial NCT06740539: Atrial Fibrillation with Heart Failure with Preserved Ejection Fraction: Treatment Strategies-Catheter Ablation Vs. Anti-Atrial Arrhythmia Drugs
Official title: Atrial Fibrillation with Heart Failure with Preserved Ejection Fraction: Treatment Strategies-Catheter Ablation Vs. Anti-Atrial Arrhythmia Drugs
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HFpEF - Heart Failure with Preserved Ejection Fraction
Atrial Fibrillation (AF)
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
Collaborators: name: The Third Affiliated Hospital of Anhui Medical University
name: Hefei Second People's Hospital
name: The Second People's Hospital of Anhui Province
name: Hefei Binhu Hospital
First posted: 2024-12-18
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.
* 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.

Primary outcomes:
measure: The primary endpoint was a composite of all-cause death or rehospitalization for worsening HF.
timeFrame: During regular follow-up visits at 3, 6, 12, 24months.
Secondary outcomes:
measure: All-Cause Mortality
timeFrame: During regular follow-up visits at 3, 6, 12, 24months.
measure: Worsening of Heart Failure Requiring Unplanned Hospitalization
timeFrame: During regular follow-up visits at 3, 6, 12, 24months.
measure: Cardiovascular Mortality
timeFrame: During regular follow-up visits at 3, 6, 12, 24months.
measure: Unplanned Hospitalization due to Cardiovascular Reason
timeFrame: During regular follow-up visits at 3, 6, 12, 24months.
measure: All-Cause Hospitalization
timeFrame: During regular follow-up visits at 3, 6, 12, 24months.
measure: Cerebrovascular Accident
timeFrame: During regular follow-up visits at 3, 6, 12, 24months.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
Study officials:
References: