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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: TaeHoon Kim — Severance Cardiovascular Hospital Yonsei University
• Study coordinator: TaeHoon Kim
• Email: thkimcardio@yuhs.ac
• Phone: +82 02-2228-8467

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.