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NCT Number: 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

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%).

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Key information

Conditions

Bradyarrhythmia Arrhythmias, Cardiac Atrioventricular Block Bradycardia Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Heart Failure Left Bundle Branch Area Pacing Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bucheon Sejong Hospital, Bucheon-si, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 19 years old and willing and capable to give informed consent
  • 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

  • Incapacitated or unable to read or write
  • Patient who is an indication of ICD or CRT
  • History of prosthetic valve surgery on tricuspid valve
  • Prior myocardial infarction including ventricular septum
  • Life expectancy < 12 months due to any condition
  • Unavailable for at least 24 months of follow-up visits
  • Pregnant or breastfeeding at the time of signing consent
  • Prior Heart transplant surgery
  • Persistent Left Superior Vena Cava (PLSVC)

Treatment and study plan

Left Bundle Branch Area Pacing

Procedure

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.

  • RBBB configuration observed during unipolar tip pacing
  • One of the following should be met:
  • Abrupt shortening of Stim-LVAT (stimulus to peak of the R wave in V6 [LV activation time]) of >10ms during increasing output
  • Short and constant stim-LVAT and the shortest stim-LVAT <75ms in non-LBBB and <85ms in LBBB
  • Programmed stimulation by pacing lead changes QRS morphology from nonselective LBB to LV septal capture
  • LBB potential (LBB-V interval of 15 to 35ms)
  • 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).

Right ventricular pacing

Procedure

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. all cause mortality

    Time frame: during 2 years after pacemaker implantation

    All cause deaths including cardiovascular and non-cardiovascular deaths.

  2. Cardiovascular mortality

    Time frame: during 2 years after pacemaker implantation

    Cardiovascular death

  3. 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.

  4. 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.

  5. 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

  6. LBB capture failure

    Time frame: during 2 years after pacemaker implantation

    failed LBB capture, confirmed by investigator

  7. 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

  8. 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

  9. 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%.

  10. 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

  11. Incidental atrial fibrillation

    Time frame: during 2 years after pacemaker implantation

    Newly developed atrial fibrillation in patients without documented atrial fibrillation

Study contacts

Contact information is provided by the study sponsor or research team.

TaeHoon Kim

CONTACT

[email protected]

+82 02-2228-8467

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 18, 2022
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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