AzTrials
AzTrials

Pacemaker ImplantationCOMPAREPACENCT06690333

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

A study testing Pacemaker in people with Pacemaker Implantation and AV Node Disease, run by NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH at 2 sites in United States.

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

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pacemaker Implantation, AV Node Disease
What is being tested?
Pacemaker
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
2 sitesUnited States
Study dates
5 Nov 2024to Dec 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 26Show fewer
  • 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

Trial locations and contacts

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

Dinesh Sharma, MD contact

(239) 624-8113

dinesh.sharma@nchmd.org

Kathy Byrd, RN contact

(239)624-8113

Kathy.Byrd@nchmd.org

United States2 sites, 2 recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Christopher Azzam, BS, 781-775-1214, cazzam@mgh.harvard.edu

    Chee Ng, M.D.

    Recruiting

  • NCH Healthcare

    Naples, Florida, 34102

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

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
Pacemaker
Keywords
pacemaker, MICRA AV, Leadless pacemaker, left bundle area pacing

What participants receive

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

  • PacemakerDevice

    Transvenous pacemaker with left bundle area pacing

  • PacemakerDevice

    Transcatheter pacemaker with MICRA AV

Study groups in NCT06690333
Study groupRoleWhat they receive
Left bundle area pacingActive comparatorTransvenous pacemaker with left bundle area pacing
Receives: Device: Pacemaker
MICRA AVActive comparatorTranscatheter pacemaker with MICRA AV
Receives: Device: Pacemaker

What is being measured

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

  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%.

    Measured: 12 months

Secondary outcomes (2)

  1. Procedure time

    measured in minutes

    Measured: from procedure start to procedure end

  2. Device longevity

    device longevity as noted on interrogation reports

    Measured: at 12 month follow up

Timeline

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

  1. First posted15 Nov 2024
  2. Study start5 Nov 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06690333
Sponsor's protocol ID
IRB0081
Other IDs
13500
Acronym
COMPAREPACE
Status last verified
May 2025
First submitted
13 Nov 2024
Last updated
30 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

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

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 27855853

  • 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

  • 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.

    PubMed 32362173

  • 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.

    PubMed 38625833

  • 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.

    PubMed 38220556

  • 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.

    PubMed 35661380

Questions about this trial

What is this clinical trial studying?

A study testing Pacemaker in people with Pacemaker Implantation and AV Node Disease, run by NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH at 2 sites in United States.

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 10 inclusion and 26 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 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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 Dinesh Sharma, MD ((239) 624-8113, dinesh.sharma@nchmd.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy & Safety (time frame: 12 months). 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 NCT06690333, which also lists 13 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 30 May 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in