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

NCT06690333 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-05-30

No results posted yet for this study

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.

Conditions

  • Pacemaker Implantation
  • AV Node Disease

Interventions

DEVICE

Pacemaker

Transvenous pacemaker with left bundle area pacing

DEVICE

Pacemaker

Transcatheter pacemaker with MICRA AV

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH

    lead OTHER

Principal Investigators

  • Dinesh Sharma, MD · NCH Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-05
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06690333 on ClinicalTrials.gov