Health TrialsbyHealthPanel

AVEIR DR Coverage With Evidence Development (CED) 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 dual chamber Aveir Leadless Pacemaker device (aka Aveir™ DR LP system).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

The study cohort will include all Medicare patients with continuous claims data implanted with an Aveir DR leadless pacemaker or a full-system dual-chamber transvenous pacemaker (from any manufacturer) in any US location

Trial design

Design model

Case-control

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 is required in this study.

  • Dual Chamber Transvenous Pacemaker

    Device

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

Treatment groups

2,812 Participants
are divided into 2 treatment groups
Group A: Aveir DR Leadless Pacemaker System1 intervention
Group B: Dual Chamber Transvenous Pacemaker1 intervention

Trial outcomes

Primary outcomes

1

Acute device related complication rate

Assess the acute (30-day) complication rate of the Aveir DR LP, compared to dual chamber transvenous pacemakers. An acute complication is defined as a peri-procedural, device-related adverse event occurring within 30 days post-implant.

Time frame
30 days
2

Two-year survival rate

Assess (2-year) survival rate of subjects implanted with an Aveir DR LP, compared to dual chamber transvenous pacemakers.

Time frame
2 years

Secondary outcomes

1

Chronic complication rate

Assess the chronic (6-month) complication rate of the Aveir DR LP, compared to dual chamber transvenous pacemakers. A chronic complication is defined as a post-procedural, device-related adverse event that requires invasive intervention to resolve, occurring more than 30 days through six months post implant.

Time frame
6 months
2

Device-related re-intervention rates

Assess (2-year) device-related re-intervention rates of the Aveir DR LP, compared to dual chamber transvenous pacemakers

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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