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AF Ablation for HF With Reduced EF

Primary Purpose

Persistent Atrial Fibrillation, Heart Failure With Reduced Ejection Fraction

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
AF ablation
medical therapy
Sponsored by
Shanghai Chest Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Atrial Fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Shanghai Chest Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

AF ablation

Medical therapy (rate or rhythm control)

Arm 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.

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

Outcomes

Primary Outcome Measures

Difference in ejection fraction between groups
Difference in left ventricular ejection fraction between groups on echocardiography at 12 months

Secondary Outcome Measures

Difference in NYHA class between groups
Difference in BNP between groups
Difference in SR survival between groups
Worsening heart failure requiring unplanned hospitalization
Change in 6-minute walk distance

Full Information

First Posted
April 11, 2023
Last Updated
April 12, 2023
Sponsor
Shanghai Chest Hospital
Collaborators
Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Yuhuan Second People's Hospital, Shanghai Yangpu District Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05827172
Brief Title
AF Ablation for HF With Reduced EF
Official Title
Catheter Ablation vs. Medical Treatment in Patients With HFrEF and Persistent AF (CAEFR-AF)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Chest Hospital
Collaborators
Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Yuhuan Second People's Hospital, Shanghai Yangpu District Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation, Heart Failure With Reduced Ejection Fraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AF ablation
Arm Type
Experimental
Arm 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.
Arm Title
Medical therapy (rate or rhythm control)
Arm Type
Other
Arm 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
Intervention Type
Procedure
Intervention Name(s)
AF ablation
Intervention 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.
Intervention Type
Other
Intervention Name(s)
medical therapy
Intervention 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. The aim of the treatment was a ventricular rate of 60 to 80 beats per minute at rest.
Primary Outcome Measure Information:
Title
Difference in ejection fraction between groups
Description
Difference in left ventricular ejection fraction between groups on echocardiography at 12 months
Time Frame
Time Frame: 12 months
Secondary Outcome Measure Information:
Title
Difference in NYHA class between groups
Time Frame
Time Frame: 12 months
Title
Difference in BNP between groups
Time Frame
Time Frame: 12 months
Title
Difference in SR survival between groups
Time Frame
Time Frame: 12 months
Title
Worsening heart failure requiring unplanned hospitalization
Time Frame
Time Frame: 12 months
Title
Change in 6-minute walk distance
Time Frame
Time Frame: 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Shanghai Chest Hospital
City
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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AF Ablation for HF With Reduced EF

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