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
Recruiting · NCT05585411 · Interventional (participants receive a specific treatment) · Lead sponsor: Yonsei University
View the official record on ClinicalTrials.gov →Interventions studied
Left bundle branch area pacingRight ventricular pacing
What this trial is about
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 take part
Age range
19 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
- Scheduled to receive a pacemaker implant 4. Substantial percentage of V pacing rate (\>40%) is anticipated
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
- Persistent Left Superior Vena Cava (PLSVC)
Where it is running
8 locations listed.
- 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