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

NCT06690333 | Recruiting DMC FDA Device

• 2 other identifiers: IRB008113500
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pacemaker Implantation; AV Node Disease

Keywords

pacemaker; MICRA AV; Leadless pacemaker; left bundle area pacing

Outcome Measures

Primary Outcomes (1)

• Efficacy & Safety

  The composite of: 1. procedural success 2. freedom from serious device-related complications at one year 3. freedom from heart failure or drop in ejection fraction below 50%.

  12 months

Secondary Outcomes (2)

• Procedure time

  from procedure start to procedure end

• Device longevity

  at 12 month follow up

Study Arms (2)

Left bundle area pacing

ACTIVE COMPARATOR

Transvenous pacemaker with left bundle area pacing

Device: Pacemaker

MICRA AV

ACTIVE COMPARATOR

Transcatheter pacemaker with MICRA AV

Device: Pacemaker

Interventions

Pacemaker DEVICE

Transvenous pacemaker with left bundle area pacing

Left bundle area pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH: lead
• Medtronic: collaborator

Study Sites (2)

NCH Healthcare

Naples, Florida, 34102, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (13)

• 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 and Biventricular Pacing in Candidates for Resynchronization Therapy. J Am Coll Cardiol. 2023 Jul 18;82(3):228-241. doi: 10.1016/j.jacc.2023.05.006. Epub 2023 May 21.

  PMID: 37220862 BACKGROUND

• 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. doi: 10.1016/j.hrthm.2018.05.004. Epub 2018 May 11.

  PMID: 29758405 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 30586772 BACKGROUND

• Huang HD, Mansour M. Pacemaker Implantation After Transcatheter Aortic Valve Replacement: A Necessary Evil Perhaps But Are We Making Progress? J Am Heart Assoc. 2020 May 5;9(9):e016700. doi: 10.1161/JAHA.120.016700. Epub 2020 May 2. No abstract available.

  PMID: 32362173 BACKGROUND

• Dell'Era G, Baroni M, Frontera A, Ghiglieno C, Carbonaro M, Penela D, Romano C, Giordano F, Del Monaco G, Galimberti P, Mazzone P, Patti G. Left bundle branch area versus conventional pacing after transcatheter valve implant for aortic stenosis: the LATVIA study. J Cardiovasc Med (Hagerstown). 2024 Jun 1;25(6):450-456. doi: 10.2459/JCM.0000000000001619. Epub 2024 Apr 1.

  PMID: 38625833 BACKGROUND

• Kassab K, Patel J, Feseha H, Kaynak E. MICRA AV implantation after transcatheter aortic valve replacement. Cardiovasc Revasc Med. 2024 Jun;63:31-35. doi: 10.1016/j.carrev.2024.01.005. Epub 2024 Jan 12.

  PMID: 38220556 BACKGROUND

• Mechulan A, Prevot S, Peret A, Nait-Saidi L, Miliani I, Leong-Feng L, Leude-Vaillant E, Vaillant A, Cornen A, Latiere B, Giacomoni MP, Collet F, Bechet V, Bouharaoua A, Dieuzaide P. Micra AV leadless pacemaker implantation after transcatheter aortic valve implantation. Pacing Clin Electrophysiol. 2022 Nov;45(11):1310-1315. doi: 10.1111/pace.14545. Epub 2022 Jun 13.

  PMID: 35661380 BACKGROUND

Study Officials

• Dinesh Sharma, MD

  NCH Healthcare

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dinesh Sharma, MD

CONTACT

(239) 624-8113; dinesh.sharma@nchmd.org

Kathy Byrd, RN

CONTACT

(239)624-8113; Kathy.Byrd@nchmd.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical Events Committee is masked
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 15, 2024
• Study Start: November 5, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)