|

Aveir VR Coverage With Evidence Development Post-Approval Study

RECRUITINGSponsored by Abbott Medical Devices
Actively Recruiting
SponsorAbbott Medical Devices
Started2022-06-21
Est. completion2028-01-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT05336877

Summary

The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Single-Chamber Leadless Pacemaker device (Aveir VR LP).

Eligibility

Age: 18 Years+Healthy volunteers accepted
The study cohort will include all Medicare patients with continuous claims data implanted with an Aveir VR leadless pacemaker or a full-system single-chamber ventricular transvenous pacemaker (from any manufacturer) in any US location

Inclusion Criteria:

Medicare beneficiaries implanted with an Aveir VR leadless pacemaker on or after the study start date (i.e., the date of Aveir VR market approval) will be included in the study.

OR

Medicare beneficiaries implanted with a full system (e.g. lead and generator) single-chamber ventricular transvenous pacemaker on or after the study start date

Exclusion Criteria:

None

Conditions4

ArrythmiaBradycardiaCardiac PacemakerHeart Disease

Locations1 site

Abbott
Sylmar, California, 91342
Nicole Harbert972-526-4841nicole.harbert@abbott.com

Browse More Trials

Heart Disease trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.