Cardiac PacemakerNCT05932602

AVEIR DR Coverage With Evidence Development (CED) Study

An observational study of Cardiac Pacemaker and Arrythmia, run by Abbott Medical Devices at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial summary

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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiac Pacemaker, Arrythmia, Bradycardia
What is being tested?: Aveir DR Leadless Pacemaker System and Dual Chamber Transvenous Pacemaker
Type of treatment: Medical device
How many people: 2,812 participants
Where: 1 siteUnited States
Study dates: 31 Oct 2023to May 2030
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study 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

Who may be able to join

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

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

United States1 site

Abbott
Sylmar, California, 91342

Other trials in United States

About this study

Official title: The AVEIR DR Coverage With Evidence Development (DRIVE) Study

Read the detailed description

This CED study utilizes a real-world evidence (RWE) method merging multiple real-world datasets from Abbott and the Center for Medicare Services to assess Aveir DR LP health outcomes among Medicare beneficiaries.

The study will enroll all Medicare patients with continuous claims data implanted with the Aveir DR LP system or a dual-chamber transvenous pacemaker system from any manufacturer.

Due to the RWE data collection methods used in this study, a central institutional review board (IRB) approved informed consent waiver has been granted. Due to this waiver and the sponsor's use of the central IRB, individual hospitals are not required to consent patients or complete local IRB submissions for this RWE study.

Conditions: Cardiac Pacemaker, Arrythmia, Bradycardia
Being tested: Aveir DR Leadless Pacemaker System, Dual Chamber Transvenous Pacemaker
Keywords: dual chamber, sick sinus rhythm, pacemaker, AV Block
Medical subject headings: Arrhythmias, Cardiac, Bradycardia, Atrioventricular Block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aveir DR Leadless Pacemaker SystemDevice
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 PacemakerDevice
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.

Study groups in NCT05932602
Study group	Role	What they receive
Aveir DR Leadless Pacemaker System		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. Receives: Device: Aveir DR Leadless Pacemaker System
Dual Chamber Transvenous Pacemaker		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. Receives: Device: Dual Chamber Transvenous Pacemaker

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 30 days
Two-year survival rate
Assess (2-year) survival rate of subjects implanted with an Aveir DR LP, compared to dual chamber transvenous pacemakers.
Measured: 2 years

Secondary outcomes (2)

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.
Measured: 6 months
Device-related re-intervention rates
Assess (2-year) device-related re-intervention rates of the Aveir DR LP, compared to dual chamber transvenous pacemakers
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Oct 2023May 2030

First posted6 Jul 2023
Study start31 Oct 2023
Primary completionMay 2029 (estimated)
Study completionMay 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cardiac PacemakerStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 2,812 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05932602
Sponsor's protocol ID: ABT-CIP-1020548
Status last verified: Oct 2026
First submitted: 23 Jun 2023
Last updated: 19 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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