AF Ablation for HF With Reduced EF

Shanghai Jiao Tong University

Status: Completed

Conditions: Persistent Atrial Fibrillation; Heart Failure With Reduced Ejection Fraction

Treatments: Procedure: AF ablation; Other: medical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05827172

CAEFR-AF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

AF ablation

Experimental group

Description:

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.

Treatment:

Procedure: AF ablation

Medical therapy (rate or rhythm control)

Other group

Description:

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

Treatment:

Other: medical therapy