Efficacy and Safety of Leadless Pacemakers Versus Left Bundle Area Pacing - A Preliminary Exploration

Part of paid clinical trials in Naples, Florida.

Sponsor
NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH
Study ID
NCT06690333
Status
Recruiting
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Conditions

  • AV Node Disease
  • Pacemaker Implantation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pacemaker — DEVICE
    Transvenous pacemaker with left bundle area pacing
  • Pacemaker — DEVICE
    Transcatheter pacemaker with MICRA AV

Study Details

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 Dates

Start date
Nov 5, 2024
Status verified
May 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Left bundle area pacing
    Transvenous pacemaker with left bundle area pacing
  • Active Comparator: MICRA AV
    Transcatheter pacemaker with MICRA AV

Primary Outcome Measure

Efficacy & Safety [ Time Frame: 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
NCH HealthcareNaplesFlorida34102
Kathy Byrd, RN
[email protected]
(239)624-8113
Massachusetts General HospitalBostonMassachusetts02114
Christopher Azzam, BS
[email protected]
781-775-1214
Chee Ng, M.D. (PRINCIPAL_INVESTIGATOR)

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By research site
NCH Healthcare· Naples, FLMassachusetts General Hospital· Boston, MA

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