RECRUITING

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

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. 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 ImplantationAV Node Disease
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Related Conditions:

Pacemaker ImplantationAV Node Disease

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Pacemaker Implantation
Intervention / Treatment

-

Contacts and Locations

Naples

NCH Healthcare, Naples, Florida, United States, 34102

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age \> 18
  • 2. Planned for permanent pacemaker implantation for AV node disease (first, second or third degree)
  • 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
  • 1. Sinus node dysfunction, anticipating atrial pacing or 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 Tricuspid valve regurgitation
  • 6. Moderate to 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

Dinesh Sharma, MD, PRINCIPAL_INVESTIGATOR, NCH Healthcare

Study Record Dates

2026-12