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

NCT06740539 | Not Yet Recruiting DMC

• 1 other identifier: CAPHF-AF
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

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

  During regular follow-up visits at 3, 6, 12, 24months.

Secondary Outcomes (6)

• 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.

Study Arms (2)

Ablation Group

EXPERIMENTAL

Ablation Group: Received heart failure treatment combined with ablation

Procedure: Catheter ablation of atrial fibrillation

Drug Control Group

NO INTERVENTION

Received heart failure treatment combined with heart rate control.

Interventions

Catheter ablation of atrial fibrillation PROCEDURE

Catheter ablation of atrial fibrillation

Ablation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead
• The Third Affiliated Hospital of Anhui Medical University: collaborator
• Hefei Second People's Hospital: collaborator
• The Second People's Hospital of Anhui Province: collaborator
• Hefei Binhu Hospital: collaborator

Study Sites (1)

Shanghai Chest Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mu Qin, Dr

CONTACT

+8613052320103; qinmuae@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 18, 2024
• Study Start: December 16, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)