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Efficacy and Safety of Leadless Pacemakers Versus Left Bundle Area Pacing - A Preliminary Exploration
Sponsor: 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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2024-11-05
Completion Date
2026-12
Last Updated
2025-05-30
Healthy Volunteers
No
Conditions
Interventions
Pacemaker
Transvenous pacemaker with left bundle area pacing
Pacemaker
Transcatheter pacemaker with MICRA AV
Locations (2)
NCH Healthcare
Naples, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States