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

NCT06125925 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 436

Last updated 2023-12-11

No results posted yet for this study

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

Interventions

PROCEDURE

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.

DRUG

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.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-06
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06125925 on ClinicalTrials.gov