AF Ablation for HF With Reduced EF

Heart Failure With Reduced Ejection Fraction Clinical Trial

Official title:

Catheter Ablation vs. Medical Treatment in Patients With HFrEF and Persistent AF (CAEFR-AF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05827172
• Other study ID #: CAEFR-AF
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: January 31, 2023

Study information

• Verified date: April 2023
• Source: Shanghai Chest Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: January 31, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure With Reduced Ejection Fraction
• Persistent Atrial Fibrillation

Intervention

Procedure:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Shanghai Chest Hospital	Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Shanghai Yangpu District Central Hospital, Yuhuan Second People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in ejection fraction between groups	Difference in left ventricular ejection fraction between groups on echocardiography at 12 months	Time Frame: 12 months
Secondary	Difference in NYHA class between groups		Time Frame: 12 months
Secondary	Difference in BNP between groups		Time Frame: 12 months
Secondary	Difference in SR survival between groups		Time Frame: 12 months
Secondary	Worsening heart failure requiring unplanned hospitalization		Time Frame: 12 months
Secondary	Change in 6-minute walk distance		Time Frame: 12 months