Health TrialsbyHealthPanel

Aveir VR Coverage With Evidence Development 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 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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Aveir VR Leadless Pacemaker System

    Device

    This study will utilize real-world data from patients implanted with the Aveir VR Leadless Pacemaker System. No device intervention is required in this study.

  • Single-Chamber Transvenous Pacemaker

    Device

    This study will utilize real-world data from patients implanted with a single-chamber transvenous pacemaker as a comparator to the Aveir VR LP system study arm. No device intervention is required in this study.

Treatment groups

8,744 Participants
are divided into 2 treatment groups
Group A: Device: Aveir VR Leadless Pacemaker System1 intervention
Group B: Device: Single-Chamber Transvenous Pacemaker1 intervention

Trial outcomes

Primary outcomes

1

Number of Subjects with Acute Device-Related Complications

Rate of acute complications in subjects implanted with an Aveir VR LP compared to subjects implanted with a single-chamber ventricular transvenous pacemaker. Acute complications are defined as a peri-procedural, device-related adverse event within 30 days post-implant.

Time frame
30 days
2

Number of Subjects Alive after 2 Years

The 2-year survival rate of subjects implanted with an Aveir VR LP compared with subjects implanted with single-chamber ventricular transvenous pacemaker.

Time frame
2 years

Secondary outcomes

1

Number of Subjects with Chronic Device-Related Complications

Rate of chronic complications in subjects implanted with Aveir VR LP compared with subjects implanted with a single-chamber ventricular transvenous pacemaker, from 31 days through six months post implant procedure. A chronic complication is defined as a post-procedural, device-related adverse event that requires invasive intervention to resolve.

Time frame
6 months
2

Number of Subjects with a Device-Related Re-Intervention

Rate of device-related re-intervention in subjects implanted with an Aveir VR LP compared to subjects implanted with a single-chamber ventricular transvenous pacemaker, through 2 years post implant procedure.

Time frame
2 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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