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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
Insertion of an LBBP lead (Medtronic SelectSecure™ 3830) and performing AVJ ablation to ensure heart rate regularization and ventricular synchronization
Participants receive standard ICD implantation with a minimal ventricular pacing strategy
Division of Cardiology, Yonsei University College of Medicine.
Seoul, South Korea
Composite of all-cause mortality, heart failure hospitalization, or urgent heart transplantation
Occurrence of the first event among the composite components
Time frame: Time Frame: Up to 12 months
All cause mortality
All cause deaths including cardiovascular and non-cardiovascular deaths.
Time frame: Up to 12 months
Cardiovascular mortality
Cardiovascular death
Time frame: Up to 12 months
Heart failure hospitalization
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.
Time frame: Up to 12 months
Urgent heart transplantation
Urgent heart transplantation
Time frame: Up to 12 months
LV systolic function
LVEF measure by echocardiography
Time frame: 6months and 12months
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