Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06690333

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

Led by NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH · Updated on 2025-05-30

75

Participants Needed

2

Research Sites

108 weeks

Total Duration

On this page

Sponsors

N

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

Lead Sponsor

M

Medtronic

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  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

Not Eligible

You will not qualify if you...

  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

AI-Screening

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Trial Site Locations

Total: 2 locations

1

NCH Healthcare

Naples, Florida, United States, 34102

Actively Recruiting

2

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

D

Dinesh Sharma, MD

CONTACT

K

Kathy Byrd, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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