Aveir DR Real-World Evidence Post-Approval Study

Part of paid clinical trials in Sylmar, California.

Sponsor
Abbott Medical Devices
Study ID
NCT05935007
Status
Recruiting
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Conditions

  • Arrythmia
  • Bradycardia
  • Cardiac Pacemaker

Eligibility Criteria

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

Interventions

  • Aveir DR Leadless Pacemaker System — DEVICE
    This study will utilize real-world data from patients implanted with the Aveir DR Leadless Pacemaker System. No device intervention will be conducted in this study.

Study Details

The purpose of this post-approval study is to evaluate the long-term safety of the dual-chamber Aveir DR leadless pacemaker using real-world evidence methods.

Key Dates

Start date
Oct 31, 2023
Status verified
May 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
1,805 participants (estimated)

Arms

  • Arm: Interventions
    Device: Aveir DR Leadless Pacemaker System This study will utilize real-world data from patients implanted with the Aveir DR Leadless Pacemaker System. No device intervention will be conducted in this study.

Primary Outcome Measure

Number of Subjects Free from Acute Aveir DR System-Related Complications [ Time Frame: 30 Days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
AbbottSylmarCalifornia91342
Nicole Harbert
[email protected]
972-526-4841

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By research site
Abbott· Sylmar, CA

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