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Aveir DR i2i Study

NCT05252702 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 464

Last updated 2025-08-15

Study results available
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Summary

Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.

Conditions

  • Cardiac Pacemaker, Artificial
  • Cardiac Rhythm Disorder
  • Bradycardia

Interventions

DEVICE

Aveir DR Leadless Pacemaker System

Patients will undergo a dual chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right ventricle and right atrium

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
2022-02-02
Primary Completion
2023-08-02
Completion
2025-11-30
FDA Device
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Czechia
  • France
  • Hong Kong
  • Italy
  • Japan
  • Netherlands
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

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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 NCT05252702 on ClinicalTrials.gov