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

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).

Study Overview

• Status: Recruiting
• Conditions: Bradycardia; Arrhythmia; Cardiac Pacemaker
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 586

Contacts and Locations

• Study Contact: Name: Nicole Harbert; Phone Number: 972-526-4841; Email: Nicole.Harbert@abbott.com
• Study Contact Backup: Name: Stephanie Delgado; Phone Number: 818-493-3285; Email: Stephanie.delgado1@abbott.com

Study Locations

• United States
  • California
    • Sylmar, California, United States, 91342
      • Recruiting
      • Abbott
      • Contact: Nicole Harbert; Phone Number: 972-526-4841

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

1. 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.

   OR

2. 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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 transvenous 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute device-related complication rate	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.	30 days
Two-year survival rate	Assess (2-year) survival rate of subjects implanted with an Aveir AR LP, compared to single chamber atrial transvenous pacemakers.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic complication rate	• 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.	6 months
Device related re-intervention rate	• To assess (2-year) device-related re-intervention rates of the Aveir AR LP, compared to single chamber atrial transvenous pacemakers.	2 years

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Nicole Harbert, Abbott

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2024
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2031

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: October 20, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Bradycardia
• Other Study ID Numbers: ABT-CIP-CL1021378

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes