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Not yet recruiting NCT06740539

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

No phase Interventional HFpEF - Heart Failure with Preserved Ejection Fraction Atrial Fibrillation (AF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Catheter ablation of atrial fibrillation.
Who it may be relevant to
Registry conditions: HFpEF - Heart Failure with Preserved Ejection Fraction, Atrial Fibrillation (AF). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Procedure Catheter ablation of atrial fibrillation
    Catheter ablation of atrial fibrillation

Primary outcome measures

  • 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.]
Secondary outcome measures (6)
  • All-Cause Mortality [Time frame: During regular follow-up visits at 3, 6, 12, 24months.]
  • Worsening of Heart Failure Requiring Unplanned Hospitalization [Time frame: During regular follow-up visits at 3, 6, 12, 24months.]
  • Cardiovascular Mortality [Time frame: During regular follow-up visits at 3, 6, 12, 24months.]
  • Unplanned Hospitalization due to Cardiovascular Reason [Time frame: During regular follow-up visits at 3, 6, 12, 24months.]
  • All-Cause Hospitalization [Time frame: During regular follow-up visits at 3, 6, 12, 24months.]
  • Cerebrovascular Accident [Time frame: During regular follow-up visits at 3, 6, 12, 24months.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Chest Hospital — Shanghai

Identifiers

NCT: NCT06740539 · CAPHF-AF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗