ARRIVE: Aveir AR Coverage With Evidence Development (CED) Study

Sponsor

Abbott Medical Devices (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06100770

Collaborator

(none)

586

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief 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 Atrial Leadless Pacemaker device (aka Aveir™ AR LP system).

Condition or Disease	Intervention/Treatment	Phase
Cardiac Pacemaker Arrhythmia Bradycardia	Device: Aveir AR Leadless Pacemaker Device: Single-chamber atrial transvenous pacemaker

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 AR LP health outcomes among Medicare beneficiaries.

The study will enroll all Medicare patients with continuous claims data implanted with the Aveir AR LP or a single-chamber atrial 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

586 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Aveir AR Coverage With Evidence Development (CED) Study

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jan 1, 2030

Anticipated Study Completion Date :

Jan 1, 2031

Arms and Interventions

Arm	Intervention/Treatment
Aveir AR Leadless Pacemaker This study will utilize real-world data from patients implanted with the Aveir AR Leadless Pacemaker. No device intervention is required in this study.	Device: Aveir AR Leadless Pacemaker This study will utilize real-world data from patients implanted with the Aveir AR Leadless Pacemaker. No device intervention is required in this study.
Single-Chamber Atrial Transvenous Pacemaker This study will utilize real-world data from patients implanted with a single-chamber atrial pacemaker as a comparator to the Aveir AR LP study arm. No device intervention is required in this study.	Device: Single-chamber atrial transvenous pacemaker This study will utilize real-world data from patients implanted with a single-chamber atrial transvenous pacemaker as a comparator to the Aveir AR LP study arm. No device intervention is required in this study

Arm

Intervention/Treatment

Aveir AR Leadless Pacemaker

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

Device: Aveir AR Leadless Pacemaker

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

Single-Chamber Atrial Transvenous Pacemaker

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

Device: Single-chamber atrial transvenous pacemaker

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

Outcome Measures

Primary Outcome Measures

Acute device-related complication rate [30 days]
Assess the acute (30-day) complication rate of the Aveir AR LP, compared to single chamber atrial transvenous pacemakers. An acute complication is defined as a peri-procedural, device-related adverse event occurring within 30 days post-implant.
Two-year survival rate [2 years]
Assess (2-year) survival rate of subjects implanted with an Aveir AR LP, compared to single chamber atrial transvenous pacemakers.

Secondary Outcome Measures

Chronic complication rate [6 months]
• To assess the chronic (6-month) complication rate of the Aveir AR LP, compared to single chamber atrial 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.
Device related re-intervention rate [2 years]
• To assess (2-year) device-related re-intervention rates of the Aveir AR LP, compared to single chamber atrial transvenous pacemakers.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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

Exclusion Criteria:

None

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Abbott Medical Devices

Investigators

Study Director: Nicole Harbert, Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abbott Medical Devices

ClinicalTrials.gov Identifier:

NCT06100770

Other Study ID Numbers:

ABT-CIP-CL1021378

First Posted:

Oct 25, 2023

Last Update Posted:

Oct 31, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Bradycardia

Study Results

No Results Posted as of Oct 31, 2023