Efficacy and Safety of Leadless Pacemakers Versus Left Bundle Area Pacing - A Preliminary Exploration
NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH
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.
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 u…
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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 co…
Interventions
- DevicePacemaker
Transvenous pacemaker with left bundle area pacing
- DevicePacemaker
Transcatheter pacemaker with MICRA AV
Locations (2)
- NCH HealthcareNaples, Florida
- Massachusetts General HospitalBoston, Massachusetts