AzTrials
AzTrials

BradyarrhythmiaNCT05585411

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

A study testing Left bundle branch area pacing and Right ventricular pacing in people with Bradyarrhythmia and Atrioventricular Block, run by Yonsei University at 8 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Left bundle branch area pacing and Right ventricular pacing
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
8 sitesSouth Korea
Study dates
1 Nov 2022to 1 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Pregnant or breastfeeding at the time of signing consent
  • Prior Heart transplant surgery
  • Persistent Left Superior Vena Cava (PLSVC)

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

TaeHoon Kim contact

+82 02-2228-8467

thkimcardio@yuhs.ac

8 sites in 1 country

South Korea8 sites, 8 recruiting

  • Bucheon Sejong Hospital

    Bucheon-si

    Sang-Weon Park, 032-340-1694, swparkmd@gmail.com

    Recruiting

  • GyeongSang National University Changwon Hospital

    Changwon

    Ga-In Yu, 010-4409-0602, yugainb@gmail.com

    Recruiting

  • Chungbuk National University Hospital

    Chungju

    Min Kim, 043-269-6707, pupets01@gmail.com

    Recruiting

  • Asan Medical Center

    Seoul

    Min-Soo Cho, 02-3010-1327, d070294@gmail.com

    Recruiting

  • Kyunghee University hospital

    Seoul

    Jin-Bae Kim, 010-9996-6930, jinbbai@khu.ac.kr

    Recruiting

  • Seoul National University Hospital

    Seoul

    Eue-Keun Choi, 02-2072-2228, choiek417@gmail.com

    Recruiting

  • Seoul Saint Mary's Hospital

    Seoul

    Young Choi, 010-2214-2694, superstar@catholic.ac.kr

    Recruiting

  • Yonsei University Health System, Severance Hospital

    Seoul

    TaeHoon Kim, +82 02-2228-8467, thkimcardio@yuhs.ac

    Not yet recruiting

Other trials in South Korea

About this study

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%).

Read the 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.

Being tested
Left bundle branch area pacing, Right ventricular pacing
Keywords
Left Bundle Branch Area pacing, Right Ventricular Pacing, Heart Failure, Atrioventricular block
Medical subject headings
Bradycardia, Atrioventricular Block, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Left bundle branch area pacingProcedure or surgery

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

    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

Study groups in NCT05585411
Study groupRoleWhat they receive
LBBAP groupExperimentalIn this arm, a left bundle branch area pacing(LBBAP) lead will be attempted to be placed.
Receives: Procedure: Left bundle branch area pacing
RVP groupActive comparatorIn this arm, a Right ventricular pacing (RVP) lead will be attempted to be placed.
Receives: Procedure: Right ventricular pacing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. composite of all-cause death, heart failure hospitalization, occurrence of pacing induced cardiomyopathy, and an upgrade to cardiac resynchronization therapy

    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).

    Measured: during 2 years after pacemaker implantation

Secondary outcomes (11)

  1. all cause mortality

    All cause deaths including cardiovascular and non-cardiovascular deaths.

    Measured: during 2 years after pacemaker implantation

  2. Cardiovascular mortality

    Cardiovascular death

    Measured: during 2 years after pacemaker implantation

  3. 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.

    Measured: during 2 years after pacemaker implantation

  4. success rate of LBBAP implantation

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

    Measured: during 3days after pacemaker implantation

  5. LBBAP related complications

    Loss of lead function or need for lead revision, extraction, replacement for any reason

    Measured: during 2 years after pacemaker implantation

  6. LBB capture failure

    failed LBB capture, confirmed by investigator

    Measured: during 2 years after pacemaker implantation

  7. Short-term procedure and Device related complications

    composite of device and procedure related complications until 7 days after procedure

    Measured: during 1wk after pacemaker implantation

  8. Long-term procedure and Device related complications

    composite of device and procedure related complications after 7 days after procedure

    Measured: during 1wk after pacemaker implantation

  9. Rate of LV systolic dysfunction

    LVEF <50% and absolute reduction in LVEF >10%, and/or an increase in LVESV ≥15%.

    Measured: 6month and 2yr after pacemaker implantation

  10. Changes in cardiopulmonary exercise test parameters

    (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

    Measured: 6month and 2yr after pacemaker implantation

  11. Incidental atrial fibrillation

    Newly developed atrial fibrillation in patients without documented atrial fibrillation

    Measured: during 2 years after pacemaker implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2022
  2. Study start1 Nov 2022
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05585411
Sponsor's protocol ID
4-2022-0824
Status last verified
Dec 2025
First submitted
14 Oct 2022
Last updated
5 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tops LF, Schalij MJ, Bax JJ. The effects of right ventricular apical pacing on ventricular function and dyssynchrony implications for therapy. J Am Coll Cardiol. 2009 Aug 25;54(9):764-76. doi: 10.1016/j.jacc.2009.06.006.

    PubMed 19695453

  • Tse HF, Lau CP. Long-term effect of right ventricular pacing on myocardial perfusion and function. J Am Coll Cardiol. 1997 Mar 15;29(4):744-9. doi: 10.1016/s0735-1097(96)00586-4.

    PubMed 9091519

  • Sweeney MO, Hellkamp AS, Ellenbogen KA, Greenspon AJ, Freedman RA, Lee KL, Lamas GA; MOde Selection Trial Investigators. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation. 2003 Jun 17;107(23):2932-7. doi: 10.1161/01.CIR.0000072769.17295.B1. Epub 2003 Jun 2.

    PubMed 12782566

  • Wilkoff BL, Cook JR, Epstein AE, Greene HL, Hallstrom AP, Hsia H, Kutalek SP, Sharma A; Dual Chamber and VVI Implantable Defibrillator Trial Investigators. Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. JAMA. 2002 Dec 25;288(24):3115-23. doi: 10.1001/jama.288.24.3115.

    PubMed 12495391

  • Abdelrahman M, Subzposh FA, Beer D, Durr B, Naperkowski A, Sun H, Oren JW, Dandamudi G, Vijayaraman P. Clinical Outcomes of His Bundle Pacing Compared to Right Ventricular Pacing. J Am Coll Cardiol. 2018 May 22;71(20):2319-2330. doi: 10.1016/j.jacc.2018.02.048. Epub 2018 Mar 10.

    PubMed 29535066

  • Kusumoto FM, Schoenfeld MH, Barrett C, Edgerton JR, Ellenbogen KA, Gold MR, Goldschlager NF, Hamilton RM, Joglar JA, Kim RJ, Lee R, Marine JE, McLeod CJ, Oken KR, Patton KK, Pellegrini CN, Selzman KA, Thompson A, Varosy PD. 2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Circulation. 2019 Aug 20;140(8):e382-e482. doi: 10.1161/CIR.0000000000000628. Epub 2018 Nov 6. No abstract available.

    PubMed 30586772

  • Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, Barrabes JA, Boriani G, Braunschweig F, Brignole M, Burri H, Coats AJS, Deharo JC, Delgado V, Diller GP, Israel CW, Keren A, Knops RE, Kotecha D, Leclercq C, Merkely B, Starck C, Thylen I, Tolosana JM; ESC Scientific Document Group. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021 Sep 14;42(35):3427-3520. doi: 10.1093/eurheartj/ehab364. No abstract available.

    PubMed 34455430

  • Huang W, Su L, Wu S, Xu L, Xiao F, Zhou X, Mao G, Vijayaraman P, Ellenbogen KA. Long-term outcomes of His bundle pacing in patients with heart failure with left bundle branch block. Heart. 2019 Jan;105(2):137-143. doi: 10.1136/heartjnl-2018-313415. Epub 2018 Aug 9.

    PubMed 30093543

  • Vijayaraman P, Ponnusamy S, Cano O, Sharma PS, Naperkowski A, Subsposh FA, Moskal P, Bednarek A, Dal Forno AR, Young W, Nanda S, Beer D, Herweg B, Jastrzebski M. Left Bundle Branch Area Pacing for Cardiac Resynchronization Therapy: Results From the International LBBAP Collaborative Study Group. JACC Clin Electrophysiol. 2021 Feb;7(2):135-147. doi: 10.1016/j.jacep.2020.08.015. Epub 2020 Oct 28.

    PubMed 33602393

  • Sharma PS, Patel NR, Ravi V, Zalavadia DV, Dommaraju S, Garg V, Larsen TR, Naperkowski AM, Wasserlauf J, Krishnan K, Young W, Pokharel P, Oren JW, Storm RH, Trohman RG, Huang HD, Subzposh FA, Vijayaraman P. Clinical outcomes of left bundle branch area pacing compared to right ventricular pacing: Results from the Geisinger-Rush Conduction System Pacing Registry. Heart Rhythm. 2022 Jan;19(1):3-11. doi: 10.1016/j.hrthm.2021.08.033. Epub 2021 Sep 3.

    PubMed 34481985

  • Curtis AB, Worley SJ, Adamson PB, Chung ES, Niazi I, Sherfesee L, Shinn T, Sutton MS; Biventricular versus Right Ventricular Pacing in Heart Failure Patients with Atrioventricular Block (BLOCK HF) Trial Investigators. Biventricular pacing for atrioventricular block and systolic dysfunction. N Engl J Med. 2013 Apr 25;368(17):1585-93. doi: 10.1056/NEJMoa1210356.

    PubMed 23614585

Questions about this trial

What is this clinical trial studying?

A study testing Left bundle branch area pacing and Right ventricular pacing in people with Bradyarrhythmia and Atrioventricular Block, run by Yonsei University at 8 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact TaeHoon Kim (+82 02-2228-8467, thkimcardio@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05585411, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.

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