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

December 30, 2025 updated by: Yonsei University
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%).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Bucheon-si, South Korea
        • Recruiting
        • Bucheon Sejong Hospital
        • Contact:
      • Changwon, South Korea
        • Recruiting
        • Gyeongsang National University Changwon Hospital
        • Contact:
      • Chungju, South Korea
        • Recruiting
        • Chungbuk National University Hospital
        • Contact:
      • Seoul, South Korea
        • Recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, South Korea
        • Recruiting
        • Asan Medical Center
        • Contact:
      • Seoul, South Korea
        • Recruiting
        • KyungHee University Hospital
        • Contact:
      • Seoul, South Korea
        • Recruiting
        • Seoul Saint Mary's Hospital
        • Contact:
      • Seoul, South Korea
        • Not yet recruiting
        • Yonsei University Health System, Severance Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LBBAP group
In this arm, a left bundle branch area pacing(LBBAP) lead will be attempted to be placed.
Procedure: Left bundle branch area pacing

LBBAP success is defined if ventricular lead is successfully placed at interventricular septum and RBB configuration observed during unipolar tip pacing.

LBB capture is defined if fulfilling criterion 1 and at least one in criteria 2.

  1. RBBB configuration observed during unipolar tip pacing

  2. One of the following should be met:

    1. Abrupt shortening of Stim-LVAT (stimulus to peak of the R wave in V6 [LV activation time]) of >10ms during increasing output
    2. Short and constant stim-LVAT and the shortest stim-LVAT <75ms in non-LBBB and <85ms in LBBB
    3. Programmed stimulation by pacing lead changes QRS morphology from nonselective LBB to LV septal capture
    4. LBB potential (LBB-V interval of 15 to 35ms)
    5. Transition from nonselective LBB capture to selective LBB capture at near threshold outputs

If criterion 1 is fulfilled but none in criteria 2 is met, the procedure is considered to be deep septal pacing (DSP).
Active Comparator: RVP group
In this arm, a Right ventricular pacing (RVP) lead will be attempted to be placed.
Procedure: Right ventricular pacing
Right ventricular pacing is the traditional pacing modality for ventricular pacing. Implantation of a RV pacing lead (apex or septum of right ventricle) will be attempted using the standard-of-care technique first

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
composite of all-cause death, heart failure hospitalization, occurrence of pacing induced cardiomyopathy, and an upgrade to cardiac resynchronization therapy
Time Frame: during 2 years after pacemaker implantation

All-cause death: including cardiovascular and non-cardiovascular deaths.

Heart failure hospitalization: An unplanned outpatient or emergency department visit or inpatient hospitalization in which the patient presented with signs and symptoms consistent with heart failure and required intravenous therapy.

Occurrence of Pacing induced cardiomyopathy : LVEF <50% and absolute LVEF decline ≥10% or increase in LVESV ≥15% Upgrade to cardiac resynchronization therapy (CRT): Upgrade from pacemaker to CRT-Pacemaker/CRT-Defibrillator due to impaired LV function (LVEF decrease to 40% or less).
during 2 years after pacemaker implantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all cause mortality
Time Frame: during 2 years after pacemaker implantation
All cause deaths including cardiovascular and non-cardiovascular deaths.
during 2 years after pacemaker implantation
Cardiovascular mortality
Time Frame: during 2 years after pacemaker implantation
Cardiovascular death
during 2 years after pacemaker implantation
Heart failure hospitalization
Time Frame: during 2 years after pacemaker implantation
An unplanned outpatient or emergency department visit or inpatient hospitalization in which the patient presented with signs and symptoms consistent with heart failure and required intravenous therapy.
during 2 years after pacemaker implantation
success rate of LBBAP implantation
Time Frame: during 3days after pacemaker implantation
LBBAP success is defined if ventricular lead is successfully placed at interventricular septum and RBB configuration observed during unipolar tip pacing.
during 3days after pacemaker implantation
LBBAP related complications
Time Frame: during 2 years after pacemaker implantation
Loss of lead function or need for lead revision, extraction, replacement for any reason
during 2 years after pacemaker implantation
LBB capture failure
Time Frame: during 2 years after pacemaker implantation
failed LBB capture, confirmed by investigator
during 2 years after pacemaker implantation
Short-term procedure and Device related complications
Time Frame: during 1wk after pacemaker implantation
composite of device and procedure related complications until 7 days after procedure
during 1wk after pacemaker implantation
Long-term procedure and Device related complications
Time Frame: during 1wk after pacemaker implantation
composite of device and procedure related complications after 7 days after procedure
during 1wk after pacemaker implantation
Rate of LV systolic dysfunction
Time Frame: 6month and 2yr after pacemaker implantation
LVEF <50% and absolute reduction in LVEF >10%, and/or an increase in LVESV ≥15%.
6month and 2yr after pacemaker implantation
Changes in cardiopulmonary exercise test parameters
Time Frame: 6month and 2yr after pacemaker implantation
(VO2 peak, Exercise intensity, Peak Respiratory Exchange Ratio (Peak RER), Exercise time, age predicted aerobic capacity, VE/VCO2 slope, Lactate threshold, Max predicted HR, Max HR / Max predicted HR, presence of ST change , AF at Baseline, Incident AF during exercise
6month and 2yr after pacemaker implantation
Incidental atrial fibrillation
Time Frame: during 2 years after pacemaker implantation
Newly developed atrial fibrillation in patients without documented atrial fibrillation
during 2 years after pacemaker implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: TaeHoon Kim, Severance Cardiovascular Hospital Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

October 14, 2022

First Submitted That Met QC Criteria

October 14, 2022

First Posted (Actual)

October 18, 2022

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

December 30, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2022-0824

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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