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

23 aprile 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

44

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: 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.
Comparatore attivo: 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.
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline Left Ventricular Ejection Fraction (LVEF) at 12 Months
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of patients with absolute LVEF increase ≥5% at 12 months
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Yonsei University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

30 giugno 2026

Completamento primario (Stimato)

30 giugno 2029

Completamento dello studio (Stimato)

31 dicembre 2029

Date di iscrizione allo studio

Primo inviato

23 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

23 aprile 2026

Primo Inserito (Effettivo)

1 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 4-2025-1786

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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