Actively Recruiting

Age: 18Years +
All Genders
NCT05935007

Aveir DR Real-World Evidence Post-Approval Study

Led by Abbott Medical Devices · Updated on 2025-04-04

1805

Participants Needed

1

Research Sites

322 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Aveir DR Real-World Evidence Post-Approval Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Implanted with an Aveir DR leadless pacemaker
  • Continuous enrollment in Medicare Part A and Part B for 12 months prior to implant
  • Continuous enrollment in Medicare Part A and Part B for at least 30 days after implant, except in case of death within the 30-day period
  • Ability to link medical data with Medicare fee-for-service data
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Abbott

Sylmar, California, United States, 91342

Actively Recruiting

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Research Team

N

Nicole Harbert

CONTACT

S

Stephanie Delgado

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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