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

Last updated: May 21, 2024
Sponsor: Yonsei University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Low Blood Pressure (Hypotension)

Chest Pain

Treatment

Left bundle branch area pacing

Right ventricular pacing

Clinical Study ID

NCT05585411
4-2022-0824
  • Ages > 19
  • All Genders

Study 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

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 andschedule of evaluations.

3 Scheduled to receive a pacemaker implant 4. Substantial percentage of V pacing rate (>40%) is anticipated

Exclusion

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)

Study Design

Total Participants: 450
Treatment Group(s): 2
Primary Treatment: Left bundle branch area pacing
Phase:
Study Start date:
November 01, 2022
Estimated Completion Date:
November 01, 2026

Study Description

PROTECT-SYNC study is a multicenter, randomized, controlled trial that is designed to assess whether LBBAP may reduce the risk of composite primary endpoint including all cause mortalty, HF hospitalization and/or urgent HF related visit, occurrence of pacing induced CMP, and CRT-upgrade event, compared to RVP in patients who require substantial (>40%) ventricular pacing. Patients who require pacemaker and substantial (>40%) ventricular pacing will be randomized to LBBAP or RVP group, and 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.

Connect with a study center

  • Bucheon Sejong Hospital

    Bucheon,
    Korea, Republic of

    Active - Recruiting

  • GyeongSang National University Changwon Hospital

    Changwon,
    Korea, Republic of

    Active - Recruiting

  • Chungbuk National University Hospital

    Chungju,
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Kyunghee University hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul Saint Mary's Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Yonsei University Health System, Severance Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

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