AV Node Disease, Pacemaker Implantation
Conditions
Keywords
pacemaker, MICRA AV, Leadless pacemaker, left bundle area pacing
Brief summary
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.
Detailed 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. This study is designed to compare the safety and effectiveness of two types of pacemaker treatments: leadless pacemakers and left bundle area pacing. Patients who's heart rhythm indicate a degree of heart block that slows the heart beat and decreases the amount of blood the heart is pumping to the rest of the body will be identified by physicians to participate. This study seeks to improve our understanding of heart rhythm disorders to allow us to provide the best treatment for our patients.
Interventions
DEVICEPacemaker
Transvenous pacemaker with left bundle area pacing
Sponsors
Medtronic
NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Clinical Events Committee is masked
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy & Safety | 12 months | The composite of: 1. procedural success 2. freedom from serious device-related complications at one year 3. freedom from heart failure or drop in ejection fraction below 50%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure time | from procedure start to procedure end | measured in minutes |
| Device longevity | at 12 month follow up | device longevity as noted on interrogation reports |
Countries
United States
Contacts
Primary ContactDinesh Sharma, MD
Backup ContactKathy Byrd, RN
Outcome results
None listed