NCT05827172

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
Last Updated

April 24, 2023

Status Verified

April 1, 2023

Enrollment Period

1.6 years

First QC Date

April 11, 2023

Last Update Submit

April 12, 2023

Conditions

Persistent Atrial FibrillationHeart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (1)

  • Difference in ejection fraction between groups

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

    Time Frame: 12 months

Secondary Outcomes (5)

  • Difference in NYHA class between groups

    Time Frame: 12 months

  • Difference in BNP between groups

    Time Frame: 12 months

  • Difference in SR survival 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

Study Arms (2)

AF ablation

EXPERIMENTAL

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.

Procedure: AF ablation

Medical therapy (rate or rhythm control)

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. 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

Other: medical therapy

Interventions

AF ablationPROCEDURE

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.

AF ablation
medical therapyOTHER

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.

Medical therapy (rate or rhythm control)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Chest Hospital

Shanghai, China

Location

Related Publications (1)

  • 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.

    PMID: 40393692DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 11, 2023

First Posted

April 24, 2023

Study Start

June 1, 2020

Primary Completion

December 31, 2021

Study Completion

January 31, 2023

Last Updated

April 24, 2023

Record last verified: 2023-04

Locations

CN(1)