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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

RecruitingNAAges 19 Years - anyAllYonsei University
NCT05585411 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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%).

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. At least 19 years old and willing and capable to give informed consent 2. Patients who is willing and able to comply with the prescribed follow-up tests and schedule of evaluations. 3 Scheduled to receive a pacemaker implant 4. Substantial percentage of V pacing rate (\>40%) is anticipated Exclusion criteria: 1. Incapacitated or unable to read or write 2. Patient who is an indication of ICD or CRT 3. History of prosthetic valve surgery on tricuspid valve 4. Prior myocardial infarction including ventricular septum 5. Life expectancy \< 12 months due to any condition 6. Unavailable for at least 24 months of follow-up visits 7. Pregnant or breastfeeding at the time of signing consent 8. Prior Heart transplant surgery 9. Persistent Left Superior Vena Cava (PLSVC)
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What it tests

  • Left bundle branch area pacing
  • Right ventricular pacing
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Where

8 sites
Bucheon Sejong Hospital
Bucheon-si, South Korea
GyeongSang National University Changwon Hospital
Changwon, South Korea
Chungbuk National University Hospital
Chungju, South Korea
Asan Medical Center
Seoul, South Korea
Kyunghee University hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Seoul Saint Mary's Hospital
Seoul, South Korea
Yonsei University Health System, Severance Hospital
Seoul, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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