NCT07332871

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
24mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
Jan 2026May 2028

First Submitted

Initial submission to the registry

December 18, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

January 12, 2026

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

December 18, 2025

Last Update Submit

December 30, 2025

Conditions

Heart FailureAtrial FibrillationDefibrillators, Implantable

Keywords

Left Bundle Branch Pacing (LBBP)Conduction System Pacing (CSP)Atrioventricular Junction Ablation (AVJ ablation)End-stage Heart FailureHeart TransplantationICD

Outcome Measures

Primary Outcomes (1)

  • Composite of all-cause mortality, heart failure hospitalization, or urgent heart transplantation

    Occurrence of the first event among the composite components

    Time Frame: Up to 12 months

Secondary Outcomes (5)

  • All cause mortality

    Up to 12 months

  • Cardiovascular mortality

    Up to 12 months

  • Heart failure hospitalization

    Up to 12 months

  • Urgent heart transplantation

    Up to 12 months

  • LV systolic function

    6months and 12months

Study Arms (2)

SYNC group

EXPERIMENTAL

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

Device: LBBP + AVJ Ablation with ICD

Control group

ACTIVE COMPARATOR

Standard ICD implantation with minimal ventricular pacing strategy.

Device: ICD Only

Interventions

LBBP + AVJ Ablation with ICDDEVICE

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

SYNC group
ICD OnlyDEVICE

Participants receive standard ICD implantation with a minimal ventricular pacing strategy

Control group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Yonsei University College of Medicine.

Seoul, South Korea

Location

MeSH Terms

Conditions

Heart FailureAtrial Fibrillation

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DefibrillatorsElectrodesElectrical Equipment and SuppliesEquipment and SuppliesElectrodes, ImplantedProstheses and Implants

Central Study Contacts

tae hoon kim, MD, PhD.

CONTACT

82-2-2228-8467.thkimcardio@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2025

First Posted

January 12, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

January 12, 2026

Record last verified: 2025-12

Locations

KR(1)