RecruitingNot Applicable

PReventive Effect Of Left Bundle Branch Area Pacing Versus righT vEntricular paCing on All Cause deaTh, Heart Failure Progression, and Ventricular dysSYNChrony in Patients With Substantial Ventricular Pacing (PROTECT-SYNC): Multicenter Prospective Randomized Controlled Trial

South Korea450 participantsStarted 2022-11-01

Plain-language summary

PROTECT-SYNC study is a multicenter, randomized, controlled trial. A total of 7 medical centers across Republic of Korea will enroll 450 patients during 2 years of enrollment period, and followed for 2 years of follow-up period. The purpose of this study to compare the clinical outcomes of Left Bundle Branch Area Pacing (LBBAP) compared to Right Ventricular Pacing (RVP) in bradyarrhythmia patients who require high burden of ventricular pacing (\>40%).

Who can participate

Age range19 Years

SexALL

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Inclusion criteria

✓. At least 19 years old and willing and capable to give informed consent
✓. Patients who is willing and able to comply with the prescribed follow-up tests and schedule of evaluations.

Exclusion criteria

✕. Incapacitated or unable to read or write
✕. Patient who is an indication of ICD or CRT
✕. History of prosthetic valve surgery on tricuspid valve
✕. Prior myocardial infarction including ventricular septum
✕. Life expectancy \< 12 months due to any condition
✕. Unavailable for at least 24 months of follow-up visits
✕. Pregnant or breastfeeding at the time of signing consent
✕. Prior Heart transplant surgery

What they're measuring

composite of all-cause death, heart failure hospitalization, occurrence of pacing induced cardiomyopathy, and an upgrade to cardiac resynchronization therapy

Timeframe: during 2 years after pacemaker implantation

Trial details

NCT IDNCT05585411

SponsorYonsei University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-01

Contact for this trial

TaeHoon Kim

+82 02-2228-8467 thkimcardio@yuhs.ac

View on ClinicalTrials.gov More Bradyarrhythmia trials