LBBAP vs. CS Pacing for CRT in Permanent Atrial Fibrillation and Heart Failure (SYNC-AF) (SYNC-AF)
Left Bundle Branch Area Pacing Versus Coronary Sinus Pacing for Cardiac Resynchronization Therapy for Patients With Permanent Atrial Fibrillation and Heart Failure: The SYNC-AF Trial
This is a prospective, multicenter, randomized controlled trial comparing Left Bundle Branch Area Pacing (LBBAP)-based cardiac resynchronization therapy (CRT) with conventional coronary sinus (CS) lead-based CRT in patients with permanent atrial fibrillation (AF) and heart failure (HF) who meet indications for CRT device implantation.
Atrial fibrillation and heart failure frequently coexist, and both rapid heart rate and its irregularity contribute to worsening cardiac function. Atrioventricular junction (AVJ) ablation combined with CRT (biventricular pacing) has been established as an effective strategy for rate control and cardiac resynchronization in this population, supported by Class I recommendation in the 2021 ESC guidelines. However, conventional biventricular CRT via the CS lead can induce artificial electrical dyssynchrony, particularly in patients with a narrow QRS complex, potentially limiting its benefit.
Conduction system pacing (CSP), including LBBAP, has emerged as a physiologic alternative that directly stimulates the native conduction system, preserving synchronous ventricular activation. Recent evidence (ALTERNATIVE-AF trial) suggests CSP may be superior to biventricular CRT in permanent AF patients undergoing AVJ ablation. However, no randomized controlled trial has directly compared LBBAP-based CRT with CS lead-based CRT in this specific population.
The SYNC-AF trial will randomize 44 patients (22 per arm) to either LBBAP or CS pacing for CRT. The primary endpoint is change in left ventricular ejection fraction (LVEF) at 12 months as assessed by echocardiography in a blinded core laboratory. Secondary endpoints include changes in QRS duration, major adverse clinical events, device/procedure-related complications, and ventricular arrhythmia burden.
Visão geral do estudo
Status
Descrição detalhada
ECHOCARDIOGRAPHIC CORE LAB:
All echocardiographic assessments (LVEF, LVESV, LVEDV, etc.) are performed and interpreted by a blinded independent core laboratory at Severance Hospital to ensure objective and consistent measurement.
FOLLOW-UP SCHEDULE:
Screening (implant day) → Visit 1 (2 weeks-1 month) → Visit 2 (3 months ±3 months) → Visit 3 (6 months ±3 months) → Visit 4 (12 months ±3 months).
STATISTICAL ANALYSIS:
Primary analysis follows the Intention-To-Treat (ITT) principle. Per-Protocol (PP) analysis will be performed as sensitivity analysis. The primary endpoint (LVEF change at 12 months) will be compared using Student's t-test or Wilcoxon rank-sum test. Time-to-event analyses will use Kaplan-Meier survival curves with log-rank test and Cox proportional hazards model.
SAMPLE SIZE:
44 patients total (22 per arm). Based on the assumption of an absolute 10% greater improvement in LVEF with LBBAP-CRT vs. BiV-CRT, with 80% power and 5% two-sided alpha, with 10% dropout allowance.
PARTICIPATING CENTERS:
Multiple centers in the Republic of Korea (at least 4 centers), led by Severance Hospital, Yonsei University College of Medicine.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Tae-Hoon Kim, Professor
- Número de telefone: +82-2-2228-8467
- E-mail: thkimcardio@yuhs.ac
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Age ≥19 years
- Indication for CRT (CRT-P or CRT-D) device implantation per current guidelines
- Permanent atrial fibrillation (with or without planned AVJ ablation)
- Ability to understand the purpose of the study and provide written informed consent
Exclusion Criteria:
- Prosthetic tricuspid valve
- Prior myocardial infarction involving the interventricular septal area
- Life expectancy less than 12 months
- Unable to comply with planned 12-month follow-up for any reason
- Pregnancy
- History of heart transplantation
- Persistent left superior vena cava (PLSVC)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: LBBAP Group
Participants undergo CRT device implantation (CRT-P or CRT-D) with Left Bundle Branch Area Pacing (LBBAP) as the left ventricular lead strategy.
LBBAP is attempted first; if not feasible, crossover to CS lead is permitted.
AVJ ablation is performed per clinical indication.
|
CRT device (CRT-P or CRT-D) implantation using LBBAP as the left ventricular pacing lead.
A pacing lead is advanced through the interventricular septum to achieve left bundle branch area capture, confirmed by pacing parameters and electrocardiographic criteria (RBBB-like pattern with short R-peak latency in V5/V6).
RV lead is implanted in standard fashion.
AVJ ablation may be performed per clinical indication.
|
|
Comparador Ativo: CS Pacing Group
Participants undergo CRT device implantation (CRT-P or CRT-D) with conventional Coronary Sinus (CS) lead-based pacing as the left ventricular lead strategy.
AVJ ablation is performed per clinical indication.
|
CRT device (CRT-P or CRT-D) implantation using a conventional coronary sinus (CS) lead as the left ventricular pacing lead.
The CS lead is advanced via the coronary sinus into a lateral or posterolateral cardiac vein to achieve biventricular pacing.
RV lead is implanted in standard fashion.
AVJ ablation may be performed per clinical indication.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from Baseline Left Ventricular Ejection Fraction (LVEF) at 12 Months
Prazo: Baseline (at the time of device implantation) and 12 months post-implantation
|
Change in left ventricular ejection fraction (LVEF) from baseline to 12 months post-implantation, as measured by transthoracic echocardiography performed and interpreted by a blinded independent central core laboratory.
LVEF is assessed using the biplane Simpson method.
|
Baseline (at the time of device implantation) and 12 months post-implantation
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Proportion of patients with absolute LVEF increase ≥5% at 12 months
Prazo: 12 months post-implantation
|
Echocardiographic CRT response defined as absolute improvement in LVEF of ≥5% or ≥10% from baseline at 12 months, assessed by blinded core lab.
|
12 months post-implantation
|
|
Proportion of patients with absolute LVEF increase ≥10% at 12 months
Prazo: 12 months post-implantation
|
Echocardiographic CRT response defined as absolute improvement in LVEF of ≥5% or ≥10% from baseline at 12 months, assessed by blinded core lab.
|
12 months post-implantation
|
|
Change in QRS Duration From Baseline
Prazo: Immediately post-implant and at 12 months
|
QRS duration measured from surface ECG in milliseconds.
|
Immediately post-implant and at 12 months
|
|
Time to First Treated Ventricular Arrhythmia
Prazo: Up to 12 months
|
Time from randomization to first detection of treated ventricular arrhythmia (VT/VF) recorded by the implanted device within 12 months.
|
Up to 12 months
|
|
Composite of All-Cause Death and Heart Failure Hospitalization
Prazo: Up to 12 months (first occurrence)
|
Clinical events adjudicated by an independent committee.
Heart failure hospitalization defined as unplanned outpatient/ED visit or inpatient admission with HF signs/symptoms requiring intravenous therapy.
|
Up to 12 months (first occurrence)
|
|
All-cause mortality
Prazo: Up to 12 months (first occurrence)
|
Clinical events adjudicated by an independent committee.
Heart failure hospitalization defined as unplanned outpatient/ED visit or inpatient admission with HF signs/symptoms requiring intravenous therapy.
|
Up to 12 months (first occurrence)
|
|
Heart failure hospitalization
Prazo: Up to 12 months (first occurrence)
|
Clinical events adjudicated by an independent committee.
Heart failure hospitalization defined as unplanned outpatient/ED visit or inpatient admission with HF signs/symptoms requiring intravenous therapy.
|
Up to 12 months (first occurrence)
|
|
Cardiovascular death
Prazo: Up to 12 months (first occurrence)
|
Clinical events adjudicated by an independent committee.
Heart failure hospitalization defined as unplanned outpatient/ED visit or inpatient admission with HF signs/symptoms requiring intravenous therapy.
|
Up to 12 months (first occurrence)
|
|
Immediate procedural success rate of LBBAP lead implantation
Prazo: Immediately after the implantation procedure
|
Successful LBBAP lead placement defined by achievement of left bundle branch capture with acceptable pacing threshold (≤1.5V/0.5ms),
impedance (300-1200Ω), and electrocardiographic criteria (RBBB pattern, short R-peak latency in V5/V6).
|
Immediately after the implantation procedure
|
|
Lead capture loss rate at 12 months
Prazo: 12 months post-implantation
|
Loss of left bundle branch capture or inability to maintain pacing threshold <2.5V/0.5ms
at 12 months.
|
12 months post-implantation
|
|
Composite Rate of Worsening Heart Failure by Echocardiographic Criteria
Prazo: Up to 12 months
|
Composite endpoint defined as ≥5% absolute decrease in LVEF from baseline or ≥15% increase in LVESV from baseline during follow-up.
|
Up to 12 months
|
|
Device and Procedure-Related Complications
Prazo: Up to 12 months (device/procedure-related complications within 7 days for acute; up to 12 months for chronic)
|
All device/procedure-related complications and reinterventions occurring up to 12 months, adjudicated by an independent events committee.
|
Up to 12 months (device/procedure-related complications within 7 days for acute; up to 12 months for chronic)
|
|
Reintervention Rate
Prazo: Up to 12 months
|
All device/procedure-related complications and reinterventions occurring up to 12 months, adjudicated by an independent events committee.
|
Up to 12 months
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 4-2025-1786
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .