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LBBAP vs. CS Pacing for CRT in Permanent Atrial Fibrillation and Heart Failure (SYNC-AF) (SYNC-AF)

2026년 4월 23일 업데이트: Yonsei University

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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

44

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  1. Age ≥19 years
  2. Indication for CRT (CRT-P or CRT-D) device implantation per current guidelines
  3. Permanent atrial fibrillation (with or without planned AVJ ablation)
  4. Ability to understand the purpose of the study and provide written informed consent

Exclusion Criteria:

  1. Prosthetic tricuspid valve
  2. Prior myocardial infarction involving the interventricular septal area
  3. Life expectancy less than 12 months
  4. Unable to comply with planned 12-month follow-up for any reason
  5. Pregnancy
  6. History of heart transplantation
  7. Persistent left superior vena cava (PLSVC)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
장치: Left Bundle Branch Area Pacing (LBBAP) for CRT
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.
활성 비교기: 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.
장치: Coronary Sinus (CS) Lead-Based Biventricular CRT
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change from Baseline Left Ventricular Ejection Fraction (LVEF) at 12 Months
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Proportion of patients with absolute LVEF increase ≥5% at 12 months
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Yonsei University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 30일

기본 완료 (추정된)

2029년 6월 30일

연구 완료 (추정된)

2029년 12월 31일

연구 등록 날짜

최초 제출

2026년 4월 23일

QC 기준을 충족하는 최초 제출

2026년 4월 23일

처음 게시됨 (실제)

2026년 5월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 4월 23일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 4-2025-1786

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

심부전에 대한 임상 시험

Left Bundle Branch Area Pacing (LBBAP) for CRT에 대한 임상 시험

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스폰서 및 공동 작업자

건강 상태

약물 개입

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CROs in Costa Rica

정황

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약물 개입

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스폰서 / 협력자

위치

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