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RECRUITING
NCT06690333
NA

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

View on ClinicalTrials.gov

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

Interventions

DEVICE

Pacemaker

Transvenous pacemaker with left bundle area pacing

DEVICE

Pacemaker

Transcatheter pacemaker with MICRA AV

Locations (2)

NCH Healthcare

Naples, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States