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

NCT06125925 | Recruiting DMC

• 1 other identifier: 2023-SR-659
• Study Type: interventional
• Target: 436
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation; HFpEF - Heart Failure With Preserved Ejection Fraction

Keywords

atrial fibrillation; HFpEF; radiofrequency catheter ablation; drug therapy

Outcome Measures

Primary Outcomes (1)

• Composite endpoint of worsening heart failure requiring unplanned hospitalizations or urgent visits, and cardiovascular death (Time-to-first event analysis)

  From randomization until completion of the planned follow-up, up to 36 months

Secondary Outcomes (16)

• Time to hospitalization or urgent visits for heart failure

  From randomization until completion of the planned follow-up, up to 36 months

• Time to hospitalization for heart failure

  From randomization until completion of the planned follow-up, up to 36 months

• Time to urgent visits for heart failure

  From randomization until completion of the planned follow-up, up to 36 months

• Time to cardiovascular death

  From randomization until completion of the planned follow-up, up to 36 months

• Time to all-cause death

  From randomization until completion of the planned follow-up, up to 36 months

Study Arms (2)

Radiofrequency catheter ablation (RFCA)

EXPERIMENTAL

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.

Procedure: Radiofrequency catheter ablation (RFCA)

Medical therapy

ACTIVE COMPARATOR

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.

Drug: Medical Therapy

Interventions

Radiofrequency catheter ablation (RFCA) 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.

Radiofrequency catheter ablation (RFCA)

Medical Therapy 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.

Medical therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic paroxysmal or persistent atrial fibrillation
• CHADS2-VASc score≥ 2
• Conform to the diagnosis of HFpEF
• NYHA II-IV level;
• Left ventricular ejection fraction (LVEF)≥ 50%;
• NT-proBNP≥ 300 pg/mL under sinus rhythm or NT-proBNP≥ 600 pg/mL under atrial fibrillation or flutter;
• Evidence of left ventricular diastolic dysfunction/raised left ventricular filling pressure on echocardiogram.
• Sign informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation; Nutrition Therapy

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Hailei Liu, PhD

CONTACT

+86-18094226858; liuhailei@njmu.edu.cn

Nan Wu, MD

CONTACT

+86-18351977986; wunannjmu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Heart Center

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: November 9, 2023
• Study Start: November 6, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)