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

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(SYNC AF-HTx)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011334

Enrollment

120

Registered

2025-12-16

Start date

2025-12-30

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others( left bundle branch area pacing, LBBAP + AVJ ablation) : 1. Prospective randomized two-arm comparative study: ICD-only implantation group vs. SYNC group (ICD + LBBAP + AVJ ablation) 1-1. ICD-on

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients who meet the indications for implantable cardioverter defibrillator (ICD) implantation (primary or secondary prevention) -Patients with permanent atrial fibrillation (AF) lasting for 6 months or longer, who are either not suitable for or have failed catheter ablation. -Patients with end-stage heart failure (HF) who are being considered for heart transplantation or left ventricular assist device (LVAD) implantation. -Patients with a left ventricular ejection fraction (LVEF) = 35% on a transthoracic echocardiogram performed within 6 weeks prior to enrollment. -Patients with a New York Heart Association (NYHA) functional class II or higher. -Patients who have been receiving guideline-directed medical therapy (GDMT) for at least 3 months (e.g., sacubitril/valsartan, beta-blockers, mineralocorticoid receptor antagonists, SGLT2 inhibitors, etc.). -Patients aged 19 years or older. -Patients who have provided written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: - Patients who do not understand the study content or do not consent to participate in the study. - Patients who are already enrolled in other clinical trials involving investigational drugs or heart implantable electrical devices. - Patients who already have a left ventricular assist device (LVAD). - Patients who meet the indications for cardiac resynchronization therapy (CRT). - Patients with a history of mechanical tricuspid valve replacement. - Patients for whom access via the upper limb vein is not possible. - Pregnant women or women without contraceptive plans. - Patients with a history of heart transplantation. - Patients who are unable to comply with the study protocol due to cognitive or physical reasons. - Patients with a life expectancy of 12 months or less.

Design outcomes

Primary

Measure	Time frame
The occurrence of death from any cause;heart failure-related hospitalization;emergency heart transplantation events.	—

Secondary

Measure	Time frame
LVAD(Left Ventricular Assist Device) implantation;Cardiovascular mortality;Left ventricular ejection fraction (LVEF) at the 3-month time point.;Quality of life (KCCQ or EQ-5D questionnaire);Device-related major complications	—

Countries

Korea, Republic of

Contacts

Public ContactAnna Choi

Yonsei University Health System, Severance Hospital

cardiocrc58@yuhs.ac+82-2-2228-8522

Outcome results