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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 SelectSecureâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYNC group | Experimental | Combined procedure of ICD implantation, LBBP lead insertion, and AVJ ablation. |
|
| Control group | Active Comparator | Standard ICD implantation with minimal ventricular pacing strategy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBBP + AVJ Ablation with ICD | Device | Insertion of an LBBP lead (Medtronic SelectSecureâ„¢ 3830) and performing AVJ ablation to ensure heart rate regularization and ventricular synchronization |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | All cause deaths including cardiovascular and non-cardiovascular deaths. | Up to 12 months |
| Cardiovascular mortality | Cardiovascular death |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| tae hoon kim, MD, PhD. | Contact | 82-2-2228-8467. | thkimcardio@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Yonsei University College of Medicine. | Seoul | South Korea |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D017147 | Defibrillators, Implantable |
| ID | Term |
|---|---|
| D047548 | Defibrillators |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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| ICD Only | Device | Participants receive standard ICD implantation with a minimal ventricular pacing strategy |
|
| 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. | Up to 12 months |
| Urgent heart transplantation | Urgent heart transplantation | Up to 12 months |
| LV systolic function | LVEF measure by echocardiography | 6months and 12months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D004567 |
| Electrodes, Implanted |
| D019736 | Prostheses and Implants |