NCT05585411 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
| NCT ID | NCT05585411 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yonsei University |
| Condition | Bradyarrhythmia |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2022-11-01 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 450 participants in total. It began in 2022-11-01 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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%).
Eligibility Criteria
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)
Contact & Investigator
TaeHoon Kim
PRINCIPAL INVESTIGATOR
Severance Cardiovascular Hospital Yonsei University
Frequently Asked Questions
Who can join the NCT05585411 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Bradyarrhythmia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05585411 currently recruiting?
Yes, NCT05585411 is actively recruiting participants. Contact the research team at thkimcardio@yuhs.ac for enrollment information.
Where is the NCT05585411 trial being conducted?
This trial is being conducted at Bucheon-si, South Korea, Changwon, South Korea, Chungju, South Korea, Seoul, South Korea and 4 additional locations.
Who is sponsoring the NCT05585411 clinical trial?
NCT05585411 is sponsored by Yonsei University. The principal investigator is TaeHoon Kim at Severance Cardiovascular Hospital Yonsei University. The trial plans to enroll 450 participants.