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

Last updated: December 15, 2024
Sponsor: Shanghai Chest Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Chest Pain

Hyponatremia

Treatment

Catheter ablation of atrial fibrillation

Clinical Study ID

NCT06740539
CAPHF-AF
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Age ≥18 years.

  • The patient is willing and able to comply with the protocol and has provided writteninformed consent.

  • Paroxysmal or persistent atrial fibrillation (AF).(Persistent AF was defined as AFwhich is sustained beyond 7 days, or lasting less than seven days but necessitatingpharmacologic or electric cardioversion. Included within the category of persistentAF 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 othersuitable device.)

  • Failure or intolerance of antiarrhythmic drug therapy or unwillingness to takeantiarrhythmic drugs.

  • Diagnosed with Heart Failure with Preserved Ejection Fraction (HFpEF).((1) a historyof 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 followingcardiac structural abnormalities identified by echocardiography: left ventricularhypertrophy, left atrial enlargement, or diastolic dysfunction; and (4) elevatedlevels 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 atadmis-sion.)

  • New York Heart Association class II, III, or IV.

Exclusion

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-axisview.

  • Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accidentwithin 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 contraceptivemeasures during fertility age.

  • Enrollment in another investigational drug or device study, or participation inanother telemonitoring concept.

Study Design

Total Participants: 304
Treatment Group(s): 1
Primary Treatment: Catheter ablation of atrial fibrillation
Phase:
Study Start date:
December 16, 2024
Estimated Completion Date:
January 01, 2027

Connect with a study center

  • Shanghai Chest Hospital

    Shanghai,
    China

    Site Not Available

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