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
NCT ID: NCT05585411
Last Updated: 2026-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
450 participants
INTERVENTIONAL
2022-11-01
2026-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LBBAP group
In this arm, a left bundle branch area pacing(LBBAP) lead will be attempted to be placed.
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).
RVP group
In this arm, a Right ventricular pacing (RVP) lead will be attempted to be placed.
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
Interventions
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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
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).
Eligibility Criteria
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Inclusion Criteria
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
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)
19 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Principal Investigators
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TaeHoon Kim
Role: PRINCIPAL_INVESTIGATOR
Severance Cardiovascular Hospital Yonsei University
Locations
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Bucheon Sejong Hospital
Bucheon-si, , South Korea
GyeongSang National University Changwon Hospital
Changwon, , South Korea
Chungbuk National University Hospital
Chungju, , South Korea
Asan Medical Center
Seoul, , South Korea
Kyunghee University hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Seoul Saint Mary's Hospital
Seoul, , South Korea
Yonsei University Health System, Severance Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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4-2022-0824
Identifier Type: -
Identifier Source: org_study_id
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