RECRUITING

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

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Conditions

Pacemaker ImplantationAV Node DiseasepacemakerMICRA AVLeadless pacemakerleft bundle area pacing

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-11-05
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06690333

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age \> 18
  2. 2. Planned for permanent pacemaker implantation for AV node disease (first, second or third degree)
  3. 3. Preserved ejection fraction \> 50%
  4. 4. Preserved sinus node function
  5. 5. Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements
  6. 6. Life expectancy \> 1 year
  7. 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. 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. 1. Sinus node dysfunction, anticipating atrial pacing or atrial fibrillation
  2. 2. Anatomical restriction for either MICRA or transvenous pacing such as
  3. 1. Access vein occlusion or thrombosis
  4. 2. previous radiation therapy at insertion site
  5. 3. inferior vena cava filter
  6. 3. Endstage renal disease (ESRD)/on dialysis
  7. 4. Dementia (inability to give consent)
  8. 5. Moderate to Severe Tricuspid valve regurgitation
  9. 6. Moderate to Severe Mitral valve regurgitation
  10. 7. History of mitral or tricuspid valve surgery
  11. 8. Preexisting implanted pacemaker or ICD or lead
  12. 9. Subject is allergic to titanium
  13. 10. Life expectancy \< 1 year
  14. 11. Recurrent or high risk of infections
  15. 12. Active malignancy requiring systemic chemotherapy or local chest radiation
  16. 13. Subject has myocardial infarction, unstable angina, cerebrovascular accident, or heart failure admission within 3 months of the baseline visit
  17. 14. CABG, valve surgery or PCI within the last 3 months
  18. 15. Other major cardiac surgery within the last 6 months
  19. 16. Persistent and permanent atrial fibrillation diagnosed by a healthcare provider
  20. 17. NYHA class 3 or 4 Heart Failure

Contacts and Locations

Study Contact

Dinesh Sharma, MD
CONTACT
(239) 624-8113
dinesh.sharma@nchmd.org
Kathy Byrd, RN
CONTACT
(239)624-8113
Kathy.Byrd@nchmd.org

Principal Investigator

Dinesh Sharma, MD
PRINCIPAL_INVESTIGATOR
NCH Healthcare

Study Locations (Sites)

NCH Healthcare
Naples, Florida, 34102
United States

Collaborators and Investigators

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

  • Dinesh Sharma, MD, PRINCIPAL_INVESTIGATOR, NCH Healthcare

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 Registration Dates

Study Start Date2024-11-05
Study Completion Date2026-12

Study Record Updates

Study Start Date2024-11-05
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Pacemaker Implantation
  • AV Node Disease