Comparing leadless pacemakers and left bundle area pacing for heart conditions
Efficacy and Safety of Leadless Pacemakers Versus Left Bundle Area Pacing - A Preliminary Exploration
This study is testing whether leadless pacemakers work better or as well as a different pacing method for people with heart block who need a permanent pacemaker.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Naples, Florida and 1 other locations) |
| Trial ID | NCT06690333 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized controlled trial designed to evaluate the safety and efficacy of leadless pacemakers compared to left bundle area pacing in patients with heart block. Conducted at up to three clinical sites in the United States, the study aims to enroll patients who require permanent pacemaker implantation due to AV node disease or post-TAVR complications. By analyzing the outcomes of these two treatment methods, the study seeks to enhance the understanding of heart rhythm disorders and improve patient care.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who require permanent pacemaker implantation for AV node disease or post-TAVR patients with preserved ejection fraction.
Not a fit: Patients with sinus node dysfunction or those anticipating atrial pacing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with heart rhythm disorders.
How similar studies have performed: Other studies have explored similar pacing techniques, but this specific comparison of leadless pacemakers and left bundle area pacing is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Naples, Florida and 1 other locations
- NCH Healthcare — Naples, Florida, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Dinesh Sharma, MD — NCH Healthcare
- Study coordinator: Dinesh Sharma, MD
- Email: dinesh.sharma@nchmd.org
- Phone: (239) 624-8113
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.