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

NCT ID: NCT07332871

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-05-31

Brief 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.

Detailed 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.

Conditions

Heart Failure; Atrial Fibrillation; Defibrillators, Implantable

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SYNC group

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

Group Type: EXPERIMENTAL

LBBP + AVJ Ablation with ICD

Intervention Type: DEVICE

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

Control group

Standard ICD implantation with minimal ventricular pacing strategy.

Group Type: ACTIVE_COMPARATOR

ICD Only

Intervention Type: DEVICE

Participants receive standard ICD implantation with a minimal ventricular pacing strategy

Interventions

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

Intervention Type: DEVICE

ICD Only

Participants receive standard ICD implantation with a minimal ventricular pacing strategy

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Division of Cardiology, Yonsei University College of Medicine.

Seoul, , South Korea

Countries

South Korea

Central Contacts

tae hoon kim, MD, PhD.

Role: CONTACT

thkimcardio@yuhs.ac

82-2-2228-8467.

Facility Contacts

tae hoon kim, MD, PhD

Role: primary

thkimcardio@yuhs.ac

82-2-2228-8467

Other Identifiers

4-2025-1357

Identifier Type: -

Identifier Source: org_study_id