Efficacy and Safety of Leadless Pacemakers Versus Left Bundle Area Pacing - A Preliminary Exploration
Recruiting now · Not applicable
Conditions studied: Pacemaker Implantation, AV Node Disease
In brief
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.
Key facts
- Study ID
- NCT06690333
- Run by
- NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH
- People needed
- 75
- Starts
- 2024-11-05
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-05-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age > 18
- Planned for:
- permanent pacemaker implantation for AV node disease (first, second or third degree), OR
- post-TAVR patient requiring permanent pacemaker implantation
- Preserved ejection fraction > 50%
- Preserved sinus node function
- Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements
- Life expectancy > 1 year
- 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.
- Subject has been informed of the nature of the study, agrees to its provision and has provided written informed consent, approved by the IRB
You may not qualify if…
- Sinus node dysfunction, anticipating atrial pacing or persistent atrial fibrillation
- Anatomical restriction for either MICRA or transvenous pacing such as
- Access vein occlusion or thrombosis
- previous radiation therapy at insertion site
- inferior vena cava filter
- Endstage renal disease (ESRD)/on dialysis
- Dementia (inability to give consent)
- Moderate to Severe or Severe Tricuspid valve regurgitation
- Moderate to Severe or Severe Mitral valve regurgitation
- History of mitral or tricuspid valve surgery
- Preexisting implanted pacemaker or ICD or lead
- Subject is allergic to titanium
- Life expectancy < 1 year
- Recurrent or high risk of infections
- Active malignancy requiring systemic chemotherapy or local chest radiation
- Subject has myocardial infarction, unstable angina, cerebrovascular accident, or heart failure admission within 3 months of the baseline visit
- CABG, valve surgery or PCI within the last 3 months except TAVR
- Other major cardiac surgery within the last 6 months
- Persistent and permanent atrial fibrillation diagnosed by a healthcare provider
- NYHA class 3 or 4 Heart Failure
- Additional post-TAVR Exclusion Criteria:
- Evidence of renal injury (12 hours post-TAVR)
- Access site complication(s) post-TAVR
- Suspicion of stroke/cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 12 hours post-TAVR
- Physician suspicion that ambulation to pre-TAVR activities post-pacemaker implantation would be unattainable
Where it is running
- NCH Healthcare — Naples, Florida, United States (enrolling)
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.