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NCT Number: NCT07332871

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Cardiology, Yonsei University College of Medicine.

Seoul, South Korea

Location contact

tae hoon kim, MD, PhD

CONTACT

[email protected]

82-2-2228-8467

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LBBP + AVJ Ablation with ICD

Device

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

ICD Only

Device

Participants receive standard ICD implantation with a minimal ventricular pacing strategy

Primary outcomes

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

    Time frame: Time Frame: Up to 12 months

    Occurrence of the first event among the composite components

Secondary outcomes

  1. All cause mortality

    Time frame: Up to 12 months

    All cause deaths including cardiovascular and non-cardiovascular deaths.

  2. Cardiovascular mortality

    Time frame: Up to 12 months

    Cardiovascular death

  3. Heart failure hospitalization

    Time frame: Up to 12 months

    An unplanned outpatient or emergency department visit or inpatient hospitalization in which the patient presented with signs and symptoms consistent with heart failure and required intravenous therapy.

  4. Urgent heart transplantation

    Time frame: Up to 12 months

    Urgent heart transplantation

  5. LV systolic function

    Time frame: 6months and 12months

    LVEF measure by echocardiography

Study contacts

Contact information is provided by the study sponsor or research team.

tae hoon kim, MD, PhD.

CONTACT

[email protected]

82-2-2228-8467.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

Safety and efficacY of conductioN System paCing and Atrioventricular Junctional Ablation Combined With ICD Implantation in Patients With End-stage Heart Failure and Atrial Fibrillation Eligible for Heart Transplantation (SYNC AF-HTx) : Multicenter Prospective Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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