Comparing Left Bundle Branch Area Pacing to Right Ventricular Pacing in Heart Patients

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

This study is testing whether pacing the heart from the left side works better than pacing from the right side for people with slow heartbeats who need help with their heart rhythm.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 450 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Yonsei University (other)
• Locations: 8 sites (Bucheon-si and 7 other locations)
• Trial ID: NCT05585411 on ClinicalTrials.gov

What this trial studies

The PROTECT-SYNC study is a multicenter, randomized, controlled trial aimed at evaluating the clinical outcomes of Left Bundle Branch Area Pacing (LBBAP) versus Right Ventricular Pacing (RVP) in patients with bradyarrhythmia requiring significant ventricular pacing. A total of 450 patients will be enrolled across seven medical centers in the Republic of Korea over a two-year period, followed by an additional two years of monitoring. The study will assess the impact of these pacing methods on all-cause mortality, heart failure hospitalizations, and other related complications. Participants will be randomly assigned to either the LBBAP or RVP group to determine which method yields better health outcomes.

Who should consider this trial

Good fit: Ideal candidates are patients aged 19 and older who require a pacemaker and anticipate a high burden of ventricular pacing (>40%).

Not a fit: Patients with conditions such as prior heart transplant surgery or those who are pregnant may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved heart health and reduced hospitalizations for patients requiring ventricular pacing.

How similar studies have performed: While the approach of LBBAP is gaining interest, this specific comparison with RVP is novel and has not been extensively tested in prior studies.

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)

Where this trial is running

Bucheon-si and 7 other locations

• Bucheon Sejong Hospital — Bucheon-si, South Korea (RECRUITING)
• GyeongSang National University Changwon Hospital — Changwon, South Korea (RECRUITING)
• Chungbuk National University Hospital — Chungju, South Korea (RECRUITING)
• Asan Medical Center — Seoul, South Korea (RECRUITING)
• Kyunghee University hospital — Seoul, South Korea (RECRUITING)
• Seoul National University Hospital — Seoul, South Korea (RECRUITING)
• Seoul Saint Mary's Hospital — Seoul, South Korea (RECRUITING)
• Yonsei University Health System, Severance Hospital — Seoul, South Korea (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: TaeHoon Kim — Severance Cardiovascular Hospital Yonsei University
• Study coordinator: TaeHoon Kim

Conditions: Bradyarrhythmia, Atrioventricular Block, Left Bundle Branch Area Pacing, Left Bundle Branch Area pacing, Right Ventricular Pacing, Heart Failure, Atrioventricular block