MedTrace Logo

The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System

NCT04559945 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1276

Last updated 2026-05-20

Study results available
· View outcomes & findings →

Summary

prospective, non-randomized, multi-center, international clinical study is designed to confirm the safety and effectiveness of the Aveir LP System in a subject population indicated for a VVI(R) pacemaker.

Conditions

  • Cardiac Rhythm Disorder
  • Bradycardia

Interventions

DEVICE

Aveir VR Leadless Pacemaker System

Patients will undergo an attempted leadless pacemaker implant

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Nicole Harbert · Abbott

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-13
Primary Completion
2022-07-18
Completion
2023-09-15
FDA Device
Yes

Countries

  • United States
  • Canada
  • Czechia
  • France
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

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 NCT04559945 on ClinicalTrials.gov