Efficacy and Safety of Leadless Pacemakers Versus Left Bundle Area Pacing - A Preliminary Exploration

Обзор

This is a prospective, randomized controlled (1:1) multicenter trial. The pilot study will be conducted up to three clinical sites in the United States. The primary purpose of this study is to compare the overall safety and efficacy between the leadless pacemaker and left bundle area pacing.

Подробное описание

This is a prospective, randomized controlled (1:1) multicenter trial. The pilot study will be conducted up to three clinical sites in the United States. This study is designed to compare the safety and effectiveness of two types of pacemaker treatments: leadless pacemakers and left bundle area pacing. Patients who's heart rhythm indicate a degree of heart block that slows the heart beat and decreases the amount of blood the heart is pumping to the rest of the body will be identified by physicians to participate. This study seeks to improve our understanding of heart rhythm disorders to allow us to provide the best treatment for our patients.

Вмешательства

• Устройство Pacemaker
  Transvenous pacemaker with left bundle area pacing
• Устройство Pacemaker
  Transcatheter pacemaker with MICRA AV

Первичные конечные точки

• Efficacy & Safety [Срок оценки: 12 months]

Вторичные конечные точки (2)

• Procedure time [Срок оценки: from procedure start to procedure end]
• Device longevity [Срок оценки: at 12 month follow up]

Критерии участия

Критерии включения

• Age > 18
• Planned for:

• permanent pacemaker implantation for AV node disease (first, second or third degree), OR
• post-TAVR patient requiring permanent pacemaker implantation
• Preserved ejection fraction > 50%
• Preserved sinus node function
• Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements
• Life expectancy > 1 year
• Female subject of childbearing potential is not pregnant, not breast feeding, does not plan to be pregnant during the course of the study, and agrees to use a highly effective contraceptive method (i.e. IUD, birth control, vasectomized partner, sexual abstinence, etc.) during the course of the study.
• Subject has been informed of the nature of the study, agrees to its provision and has provided written informed consent, approved by the IRB

Критерии исключения

• Sinus node dysfunction, anticipating atrial pacing or persistent atrial fibrillation
• Anatomical restriction for either MICRA or transvenous pacing such as

• Access vein occlusion or thrombosis
• previous radiation therapy at insertion site
• inferior vena cava filter
• Endstage renal disease (ESRD)/on dialysis
• Dementia (inability to give consent)
• Moderate to Severe or Severe Tricuspid valve regurgitation
• Moderate to Severe or Severe Mitral valve regurgitation
• History of mitral or tricuspid valve surgery
• Preexisting implanted pacemaker or ICD or lead
• Subject is allergic to titanium
• Life expectancy < 1 year
• Recurrent or high risk of infections
• Active malignancy requiring systemic chemotherapy or local chest radiation
• Subject has myocardial infarction, unstable angina, cerebrovascular accident, or heart failure admission within 3 months of the baseline visit
• CABG, valve surgery or PCI within the last 3 months except TAVR
• Other major cardiac surgery within the last 6 months
• Persistent and permanent atrial fibrillation diagnosed by a healthcare provider
• NYHA class 3 or 4 Heart Failure

Additional post-TAVR Exclusion Criteria:

• Evidence of renal injury (12 hours post-TAVR)
• Access site complication(s) post-TAVR
• Suspicion of stroke/cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 12 hours post-TAVR
• Physician suspicion that ambulation to pre-TAVR activities post-pacemaker implantation would be unattainable
• Other post-TAVR complications that in the opinion of the investigator may seriously confound study outcomes

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

Простое слепое

Основная цель

Другое

Центры проведения

США · 2 центра

• NCH Healthcare — Naples
• Massachusetts General Hospital — Boston

Публикации

• Vijayaraman P, Sharma PS, Cano O, Ponnusamy SS, Herweg B, Zanon F, Jastrzebski M, Zou J, Chelu MG, Vernooy K, Whinnett ZI, Nair GM, Molina-Lerma M, Curila K, Zalavadia D, Haseeb A, Dye C, Vipparthy SC, Brunetti R, Moskal P, Ross A, van Stipdonk A, George J, Qadeer YK, Mumtaz M, Kolominsky J, Zahra SA, Golian M, Marcantoni L, Subzposh FA, Ellenbogen KA. Comparison of Left Bundle Branch Area Pacing PMID 37220862
• Chinitz L, Ritter P, Khelae SK, Iacopino S, Garweg C, Grazia-Bongiorni M, Neuzil P, Johansen JB, Mont L, Gonzalez E, Sagi V, Duray GZ, Clementy N, Sheldon T, Splett V, Stromberg K, Wood N, Steinwender C. Accelerometer-based atrioventricular synchronous pacing with a ventricular leadless pacemaker: Results from the Micra atrioventricular feasibility studies. Heart Rhythm. 2018 Sep;15(9):1363-1371. PMID 29758405
• Sanchez R, Nadkarni A, Buck B, Daoud G, Koppert T, Okabe T, Houmsse M, Weiss R, Augostini R, Hummel JD, Kalbfleisch S, Daoud EG, Afzal MR. Incidence of pacing-induced cardiomyopathy in pacemaker-dependent patients is lower with leadless pacemakers compared to transvenous pacemakers. J Cardiovasc Electrophysiol. 2021 Feb;32(2):477-483. doi: 10.1111/jce.14814. Epub 2020 Nov 25. PMID 33205561
• Duray GZ, Ritter P, El-Chami M, Narasimhan C, Omar R, Tolosana JM, Zhang S, Soejima K, Steinwender C, Rapallini L, Cicic A, Fagan DH, Liu S, Reynolds D; Micra Transcatheter Pacing Study Group. Long-term performance of a transcatheter pacing system: 12-Month results from the Micra Transcatheter Pacing Study. Heart Rhythm. 2017 May;14(5):702-709. doi: 10.1016/j.hrthm.2017.01.035. Epub 2017 Feb 10. PMID 28192207
• Udo EO, Zuithoff NP, van Hemel NM, de Cock CC, Hendriks T, Doevendans PA, Moons KG. Incidence and predictors of short- and long-term complications in pacemaker therapy: the FOLLOWPACE study. Heart Rhythm. 2012 May;9(5):728-35. doi: 10.1016/j.hrthm.2011.12.014. Epub 2011 Dec 17. PMID 22182495
• 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. PMID 33602393
• Zhang S, Guo J, Tao A, Zhang B, Bao Z, Zhang G. Clinical outcomes of left bundle branch pacing compared to right ventricular apical pacing in patients with atrioventricular block. Clin Cardiol. 2021 Apr;44(4):481-487. doi: 10.1002/clc.23513. Epub 2021 Mar 11. PMID 33704810
• Kiehl EL, Makki T, Kumar R, Gumber D, Kwon DH, Rickard JW, Kanj M, Wazni OM, Saliba WI, Varma N, Wilkoff BL, Cantillon DJ. Incidence and predictors of right ventricular pacing-induced cardiomyopathy in patients with complete atrioventricular block and preserved left ventricular systolic function. Heart Rhythm. 2016 Dec;13(12):2272-2278. doi: 10.1016/j.hrthm.2016.09.027. PMID 27855853

Идентификаторы

NCT: NCT06690333 · IRB0081 · 13500

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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