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

Обзор

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%).

Подробное описание

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.

Вмешательства

• Процедура 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-L
• Процедура 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

Первичные конечные точки

• composite of all-cause death, heart failure hospitalization, occurrence of pacing induced cardiomyopathy, and an upgrade to cardiac resynchronization therapy [Срок оценки: during 2 years after pacemaker implantation]

Вторичные конечные точки (11)

• all cause mortality [Срок оценки: during 2 years after pacemaker implantation]
• Cardiovascular mortality [Срок оценки: during 2 years after pacemaker implantation]
• Heart failure hospitalization [Срок оценки: during 2 years after pacemaker implantation]
• success rate of LBBAP implantation [Срок оценки: during 3days after pacemaker implantation]
• LBBAP related complications [Срок оценки: during 2 years after pacemaker implantation]
• LBB capture failure [Срок оценки: during 2 years after pacemaker implantation]
• Short-term procedure and Device related complications [Срок оценки: during 1wk after pacemaker implantation]
• Long-term procedure and Device related complications [Срок оценки: during 1wk after pacemaker implantation]
• Rate of LV systolic dysfunction [Срок оценки: 6month and 2yr after pacemaker implantation]
• Changes in cardiopulmonary exercise test parameters [Срок оценки: 6month and 2yr after pacemaker implantation]
• Incidental atrial fibrillation [Срок оценки: during 2 years after pacemaker implantation]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

South Korea · 8 центров

• Bucheon Sejong Hospital — Bucheon-si
• GyeongSang National University Changwon Hospital — Changwon
• Chungbuk National University Hospital — Chungju
• Asan Medical Center — Seoul
• Kyunghee University hospital — Seoul
• Seoul National University Hospital — Seoul
• Seoul Saint Mary's Hospital — Seoul
• Yonsei University Health System, Severance Hospital — Seoul

Публикации

• 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. PMID 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. PMID 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. E PMID 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. PMID 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. PMID 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 H PMID 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. 202 PMID 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. PMID 30093543

Идентификаторы

NCT: NCT05585411 · 4-2022-0824

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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