Health TrialsbyHealthPanel

Aveir DR Real-World Evidence Post-Approval Study

ConditionsCardiac PacemakerArrythmiaBradycardia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAbbott Medical Devices

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Implanted with an Aveir DR leadless pacemaker

Continuous enrollment in Medicare Part A and Part B for 12 months prior to implant and for -30 days after implant, except in the case of death within the 30-day period

Ability to link with Medicare fee-for-service data

Disqualifiers

None

Trial population

All patients who had an implant of the Aveir DR device, meet inclusion/exclusion criteria, link to Medicare FFS claims, and survive past 30 days will be included in the analysis

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

1,805 Participants
are divided into 1 treatment group
Group A: Interventions1 intervention

Trial outcomes

Primary outcomes

1

Number of Subjects Free from Acute Aveir DR System-Related Complications

Freedom from key acute complications through 30 days post implant procedure

Time frame
30 Days
2

Number of Subjects Free from Chronic Aveir DR System-Related Complications

Freedom from key chronic complications from 31 days through 5 years post implant procedure procedure

Time frame
5 Years

Secondary outcomes

1

Number of Subjects Free from Individual Aveir DR Leadless Pacemaker-Related

Complication rate of the Aveir DR leadless pacemaker for key individual acute and chronic complications

Time frame
5 Years
2

Number of Subjects with End of Device Service Events

Care of subjects at the end of device service. End-of-device service is defined as any event prior to the 5-year follow-up period which results in the leadless pacemaker being explanted or deactivated, another CIED implanted, or death. All instances of the end-of-service will be summarized by event type and time to event.

Time frame
5 Years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abbott Medical Devices

Lead sponsor

Source ClinicalTrials.gov
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