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Catheter Ablation in Atrial Fibrillation Patients With HFpEF (STABLE-SR IV Trial)

NCT ID: NCT06125925

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

436 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-06

Study Completion Date

2026-11-30

Brief Summary

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To investigate whether RFCA is superior to AADs in AF patients with HFpEF on the basis of optimized anti-heart-failure drug therapy regarding their longterm clinical outcomes.

Detailed Description

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Background: Atrial Fibrillation (AF) is a common cardiac rhythm disorder and radiofrequency catheter ablation (RFCA) has become the first-line therapy in the symptomatic AF patients. Heart failure is often the sister disease with AF. Recently, RFCA was found to be superior to antiarrhythmic drugs (AADs) in heart failure patients with AF and reduced ejection fraction (HFrEF), regarding all-cause mortality and hospitalization for worsening heart failure (HF). However, in heart failure patients with AF and preserved ejection fraction (HFpEF), it remains unknown whether RFCA is superior to AADs in an even larger population, despite several nonrandomized retrospective studies. Thus, this prospective, multi-center, randomized controlled trial aims to investigate whether RFCA could better improve the clinical outcome of AF patients with HFpEF than longterm AADs use.

Aim of this study: To investigate whether RFCA is superior to AADs in AF patients with HFpEF on the basis of optimized anti-heart-failure drug therapy regarding their longterm clinical outcomes.

Design: The STABLE-SR-IV trial is an international, prospective, multi-center, randomized controlled trial. In this trial, physical examination, echocardiogram, NT-proBNP and other blood test would be assessed before enrollment. Those who conform to all the inclusion criteria and absent from any exclusion criteria would enter into a run-in period of 5 weeks (±7 days). Anticoagulation and anti-heart-failure therapy for HFpEF must be optimized according to the current guideline. After the run-in period, inclusion and exclusion criteria would be reassessed. Thereafter, all the subjects enrolled would be randomized into RFCA arm and Medical Therapy arm with a 1:1 manner, namely 218 subjects in each arm. Each arm will follow the protocol of RFCA and medical therapy, respectively. Follow-up duration of this study is up to 2\~3 years (12 month enrollment).

Conditions

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Atrial Fibrillation HFpEF - Heart Failure With Preserved Ejection Fraction

Keywords

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atrial fibrillation HFpEF radiofrequency catheter ablation drug therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The End Point and Adverse Event Committee is constituted of three experts in the field of heart failure and ablation of atrial fibrillation, but independent of the study. The End Point Adverse Event Committee have received blinded data regarding all serious adverse events, all deaths, all hospitalizations, all outpatient or emergency visits, all cerebrovascular accidents, and all first recurrences of atrial fibrillation, from the Contact Research Organization. The End Point and Adverse Event Committee was responsible for the classification of all received events, for the determination of which events fulfill the end point criteria.

Study Groups

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Radiofrequency catheter ablation (RFCA)

Radiofrequency ablation is adopted in the study, instead of cryo ablation, surgical ablation or pulsed field ablation. 3-dimensional model is constructed after transseptal puncture. Circumferential pulmonary vein isolation (CPVI) is performed with irrigated contact force catheter. Previously published STABLE-SR approach is recommended as the ablation strategy beyond CPVI.

Group Type EXPERIMENTAL

Radiofrequency catheter ablation (RFCA)

Intervention Type PROCEDURE

Radiofrequency ablation is adopted in the study, instead of cryo ablation, surgical ablation or pulsed field ablation. 3-dimensional model is constructed after transseptal puncture. Circumferential pulmonary vein isolation (CPVI) is performed with irrigated contact force catheter. Previously published STABLE-SR approach is recommended as the ablation strategy beyond CPVI.

Medical therapy

AADs should be prescribed according to the current guidelines, such as amiodarone, dronedarone, or propafenone. In brief, rhythm control is preferred, including electric cardioversion. However, rate control should be considered if rhythm control is contraindicated, intolerated or unpreferred by patients.

Group Type ACTIVE_COMPARATOR

Medical Therapy

Intervention Type DRUG

AADs should be prescribed according to the current guidelines, such as amiodarone, dronedarone, or propafenone. In brief, rhythm control is preferred, including electric cardioversion. However, rate control should be considered if rhythm control is contraindicated, intolerated or unpreferred by patients.

Interventions

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Radiofrequency catheter ablation (RFCA)

Radiofrequency ablation is adopted in the study, instead of cryo ablation, surgical ablation or pulsed field ablation. 3-dimensional model is constructed after transseptal puncture. Circumferential pulmonary vein isolation (CPVI) is performed with irrigated contact force catheter. Previously published STABLE-SR approach is recommended as the ablation strategy beyond CPVI.

Intervention Type PROCEDURE

Medical Therapy

AADs should be prescribed according to the current guidelines, such as amiodarone, dronedarone, or propafenone. In brief, rhythm control is preferred, including electric cardioversion. However, rate control should be considered if rhythm control is contraindicated, intolerated or unpreferred by patients.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Symptomatic paroxysmal or persistent atrial fibrillation
* CHADS2-VASc score≥ 2
* Conform to the diagnosis of HFpEF

1. NYHA II-IV level;
2. Left ventricular ejection fraction (LVEF)≥ 50%;
3. NT-proBNP≥ 300 pg/mL under sinus rhythm or NT-proBNP≥ 600 pg/mL under atrial fibrillation or flutter;
4. Evidence of left ventricular diastolic dysfunction/raised left ventricular filling pressure on echocardiogram.
* Sign informed consent

Exclusion Criteria

* A life expectancy below 2 years due to any non-cardiovascular condition
* Reversible atrial fibrillation, such as hyperthyroidism or hypokalemia-related atrial fibrillation
* Prior atrial fibrillation ablation
* Left atrial size≥ 55 mm
* Heart failure due to any of the following: known genetic hypertrophic cardiomyopathy, infiltrative cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, constrictive pericarditis, active myocarditis, cardiac tamponade, or uncorrected primary valvular disease
* Previous cardiac transplantation, complex congenital heart disease, rheumatic heart disease
* Any contraindication for radiofrequency catheter ablation, antiarrhythmic drugs or anticoagulation
* Acute coronary syndrome, cardiac surgery, angioplasty or cerebrovascular accident within 12 weeks before enrollment
* Severe hepatic and renal dysfunction
* Body mass index\> 50 kg/m2
* Female in period of pregnancy or breast-feeding
* Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study
* Involved in other studies
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Minglong Chen

Director of Heart Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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the First Affiliated Hospital of Nanjing Medical University

Nanjing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hailei Liu, PhD

Role: CONTACT

Phone: +86-18094226858

Email: [email protected]

Nan Wu, MD

Role: CONTACT

Phone: +86-18351977986

Email: [email protected]

Facility Contacts

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Hailei Liu

Role: primary

Other Identifiers

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2023-SR-659

Identifier Type: -

Identifier Source: org_study_id