AF Ablation for HF With Reduced EF

NCT ID: NCT05827172

Last Updated: 2023-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2023-01-31

Brief Summary

This is an open label, multi-center, randomized parallel control clinical trial, to examining thethe clinical outcomes of AF ablation on HFrEF patients with persistent atrial fibrillation.

Detailed Description

This is an open label, multi-center, randomized parallel control clinical trial. HFrEF patients with persistent atrial fibrillation are 1:1 randomized into the AF ablation group or the medical therapy (rate or rhythm control) group. Markers of HFrEF severity, including composite of death from any cause or worsening of heart failure that led to an unplanned overnight hospitalization,exercise hemodynamics, natriuretic peptide levels, and patient symptoms. and other indicators are analyzed to demonstrate the role of AF ablation in comparing the effects of AF ablation vs usual medical therapy for HFrEF patients with persistent atrial fibrillation.

Conditions

Persistent Atrial Fibrillation; Heart Failure With Reduced Ejection Fraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AF ablation

The aim of the ablation procedure was to achieve isolation of all pulmonary veins and to restore sinus rhythm.Additional ablation strategies were made at the discretion of the operators.

Group Type: EXPERIMENTAL

AF ablation

Intervention Type: PROCEDURE

The aim of the ablation procedure was to achieve isolation of all pulmonary veins and to restore sinus rhythm.Additional ablation strategies were made at the discretion of the operators.

Medical therapy (rate or rhythm control)

The medical therapy for atrial fibrillation was administered in accordance with the guidelines that were available at the time of the trial.Efforts to maintain sinus rhythm were recommended. Among patients who were treated for rate control, the recommended criteria varied according to the age of the patient. The aim of the treatment was a ventricular rate of 60 to 80 beats. per minute at rest

Group Type: OTHER

medical therapy

Intervention Type: OTHER

The medical therapy for atrial fibrillation was administered in accordance with the guidelines that were available at the time of the trial.Efforts to maintain sinus rhythm were recommended. The aim of the treatment was a ventricular rate of 60 to 80 beats per minute at rest.

Interventions

AF ablation

The aim of the ablation procedure was to achieve isolation of all pulmonary veins and to restore sinus rhythm.Additional ablation strategies were made at the discretion of the operators.

Intervention Type: PROCEDURE

medical therapy

The medical therapy for atrial fibrillation was administered in accordance with the guidelines that were available at the time of the trial.Efforts to maintain sinus rhythm were recommended. The aim of the treatment was a ventricular rate of 60 to 80 beats per minute at rest.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Symptomatic persistent atrial fibrillation Failure or intolerance of antiarrhythmic drug therapy or unwillingness to take antiarrhythmic drugs Left Ventricular Ejection Fraction <= 40% NYHA >= II Patient is willing and able to comply with the protocol and has written informed consent Age >= 18 years Optimal therapy for HF of ≥6 weeks Suitable candidate for catheter ablation or rate control for the treatment of AF N-terminal pro-B-type natriuretic peptide (NT-proBNP)/BNP levels above predetermined levels based on prior hospitalization and baseline rhythm

Exclusion Criteria

• LA dimension >6.0 cm Acute coronary syndrome, cardiac surgery, angioplasty or stroke within 2 months prior to enrollment Untreated hypothyroidism or hyperthyroidism Enrollment in another investigational drug or device study Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age Mental or physical inability to take part in the study Severe aortic or mitral valve disease Life expectancy <1 year

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Yuhuan Second People's Hospital

UNKNOWN

Sponsor Role: collaborator

Tongji University

OTHER

Sponsor Role: collaborator

Shanghai Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xu Liu

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Chest Hospital

Shanghai, , China

Countries

China

References

Song Z, Wang SY, Qidong Z, Chen N, Zhang Y, Jiang W, Wu SH, Xu K, Liu Y, Liu X, Hou X, Qin M. Catheter ablation versus medical rate control for persistent atrial fibrillation in older heart failure patients with reduced ejection fraction. Heart. 2025 Aug 12;111(17):811-817. doi: 10.1136/heartjnl-2024-324668.

Reference Type: DERIVED

PMID: 40393692 (View on PubMed)

Other Identifiers

CAEFR-AF

Identifier Type: -

Identifier Source: org_study_id