AF Ablation for HF With Reduced EF

Not Applicable

Completed

• Conditions: Persistent Atrial Fibrillation; Heart Failure With Reduced Ejection Fraction
• Interventions: Procedure: AF ablation; Other: medical therapy

• Registration Number: NCT05827172
• Lead Sponsor: Shanghai Chest Hospital

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.

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2021-12-31
• Study Completion: 2023-01-31
• Status Verified: 2023-04
• Study First Submitted: 2023-04-11
• Study First Submitted QC: 2023-04-12
• Last Update Submitted: 2023-04-12
• Study First Posted: 2023-04-24
• Last Update Posted: 2023-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AF ablation	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.
Medical therapy (rate or rhythm control)	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. 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

Primary Outcome Measures

Name	Time	Method
Difference in ejection fraction between groups	Time Frame: 12 months	Difference in left ventricular ejection fraction between groups on echocardiography at 12 months

Secondary Outcome Measures

Name	Time	Method
Difference in BNP between groups	Time Frame: 12 months
Difference in SR survival between groups	Time Frame: 12 months
Difference in NYHA class between groups	Time Frame: 12 months
Worsening heart failure requiring unplanned hospitalization	Time Frame: 12 months
Change in 6-minute walk distance	Time Frame: 12 months

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, China