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

May 26, 2025 updated by: Dinesh Sharma, NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Naples, Florida, United States, 34102
        • Recruiting
        • NCH Healthcare
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Chee Ng, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age > 18

  2. Planned for:

    1. permanent pacemaker implantation for AV node disease (first, second or third degree), OR
    2. post-TAVR patient requiring permanent pacemaker implantation
  3. Preserved ejection fraction > 50%
  4. Preserved sinus node function
  5. Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements
  6. Life expectancy > 1 year
  7. 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.
  8. Subject has been informed of the nature of the study, agrees to its provision and has provided written informed consent, approved by the IRB

Exclusion Criteria:

  1. Sinus node dysfunction, anticipating atrial pacing or persistent atrial fibrillation

  2. Anatomical restriction for either MICRA or transvenous pacing such as

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

  17. NYHA class 3 or 4 Heart Failure

    Additional post-TAVR Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Left bundle area pacing
Transvenous pacemaker with left bundle area pacing
Device: Pacemaker
Transvenous pacemaker with left bundle area pacing
Device: Pacemaker
Transcatheter pacemaker with MICRA AV
Active Comparator: MICRA AV
Transcatheter pacemaker with MICRA AV
Device: Pacemaker
Transvenous pacemaker with left bundle area pacing
Device: Pacemaker
Transcatheter pacemaker with MICRA AV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy & Safety
Time Frame: 12 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure time
Time Frame: from procedure start to procedure end
measured in minutes
from procedure start to procedure end
Device longevity
Time Frame: at 12 month follow up
device longevity as noted on interrogation reports
at 12 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH

Collaborators

Medtronic

Investigators

  • Principal Investigator: Dinesh Sharma, MD, NCH Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 13, 2024

First Submitted That Met QC Criteria

November 13, 2024

First Posted (Actual)

November 15, 2024

Study Record Updates

Last Update Posted (Actual)

May 30, 2025

Last Update Submitted That Met QC Criteria

May 26, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB0081
  • 13500 (Other Identifier: Medtronic)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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