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

Yonsei University

Status: Not yet enrolling

Conditions: Defibrillators, Implantable; Atrial Fibrillation; Heart Failure

Treatments: Device: ICD Only; Device: LBBP + AVJ Ablation with ICD

Study type: Interventional

Funder types: Other

Identifiers

NCT07332871

4-2025-1357

Details and patient eligibility

About

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.

Full description

End-stage heart failure patients often face a poor prognosis due to comorbid permanent AF, which leads to irregular heart rates and worsens ventricular function. While implantable cardioverter-defibrillators (ICDs) are standard for preventing sudden cardiac death, they may not sufficiently prevent heart failure progression in patients with narrow QRS complexes. This study explores a "SYNC" strategy using LBBP and AVJ ablation to achieve ventricular synchronization and heart rate regularization. This is a multicenter, prospective, randomized (1:1), single-blind trial involving 120 participants.

Inclusion Criteria: Participants must have LVEF≤35%, permanent AF for >6 months, and be eligible for ICD implantation while awaiting heart transplantation or LVAD.

Intervention (SYNC Group): Participants receive an ICD with an LBBP lead (Medtronic SelectSecure™ 3830) and undergo AVJ ablation.

Control Group: Participants receive standard ICD implantation with a minimal ventricular pacing setting.

Follow-up: Clinical assessments, echocardiography, and device profiles will be monitored at baseline, 1, 3, 6, and 12 months post-procedure.

Enrollment: 120 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

SYNC group

Experimental group

Description:

Combined procedure of ICD implantation, LBBP lead insertion, and AVJ ablation.

Treatment:

Device: LBBP + AVJ Ablation with ICD

Control group

Active Comparator group

Description:

Standard ICD implantation with minimal ventricular pacing strategy.

Treatment:

Device: ICD Only