AVEIR DR Coverage With Evidence Development (CED) Study

The AVEIR DR Coverage With Evidence Development (DRIVE) Study

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).

Study Overview

• Status: Recruiting
• Conditions: Bradycardia; Arrythmia; Cardiac Pacemaker
• Intervention / Treatment: Device: Aveir DR Leadless Pacemaker System; Device: Dual Chamber 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 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.

• Study Type: Observational
• Enrollment (Estimated): 2812

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; Email: Nicole.Harbert@abbott.com

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:

• 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

Exclusion Criteria:

None

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: 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.
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.	Device: 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.

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 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.	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	2 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2023
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: June 23, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: pacemaker; AV Block; dual chamber; sick sinus rhythm
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Bradycardia
• Other Study ID Numbers: ABT-CIP-1020548

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