Conduction System Pacing and AV Junction Ablation in Heart Failure With Atrial Fibrillation (SYNC AF-HTx)

NCT07332871 · tracked via the Priya Life Science South Korea tracker

Sponsor

Yonsei University

Phase

Not applicable

Started

2026-01

Last updated

2026-01-12

Condition(s) studied

Heart FailureAtrial FibrillationDefibrillators, Implantable

Investigational drug(s) / intervention(s)

LBBP + AVJ Ablation with ICDICD Only

LBBP + AVJ Ablation with ICD: Insertion of an LBBP lead (Medtronic SelectSecure™ 3830) and performing AVJ ablation to ensure heart rate regularization and ventricular synchronization

ICD Only: Participants receive standard ICD implantation with a minimal ventricular pacing strategy

Study summary

The purpose of this study is to evaluate the safety and efficacy of conduction system pacing (CSP) using left bundle branch pacing (LBBP) and atrioventricular junction (AVJ) ablation in patients with end-stage heart failure and permanent atrial fibrillation (AF). Participants who are candidates for heart transplantation or left ventricular assist device (LVAD) implantation will be randomized to either the SYNC group (ICD implantation combined with LBBP and AVJ ablation) or the control group (ICD implantation only). The investigators will compare clinical outcomes, including mortality and heart failure hospitalization, between the two strategies over a 1-year follow-up period.

Eligibility

Sex

ALL

Min age

19 Years

Max age

—

Healthy volunteers

Inclusion Criteria: Candidates for ICD implantation (primary or secondary prevention). Permanent AF (\>6 months) unsuitable for or failed catheter ablation. End-stage heart failure considering heart transplant or LVAD. LVEF ≤ 35 within 6 weeks before enrollment. NYHA functional class ≥ II. On GDMT for at least 3 months. Age ≥ 19 years. Exclusion Criteria: Existing LVAD or prior heart transplantation. Indications for cardiac resynchronization therapy (CRT). History of mechanical tricuspid valve replacement. Expected survival≤ 12 months. Inability to comply with the study protocol.

Primary outcome measure(s)

Composite of all-cause mortality, heart failure hospitalization, or urgent heart transplantation — Time Frame: Up to 12 months
Occurrence of the first event among the composite components

Trial sites (1)

Facility	City	Region	Status
Division of Cardiology, Yonsei University College of Medicine.	Seoul	South Korea

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07332871 on ClinicalTrials.gov ↗ ← All trials in South Korea