AVEIR DR Coverage With Evidence Development (CED) Study

Bradycardia Clinical Trial

Official title:

The AVEIR DR Coverage With Evidence Development (DRIVE) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05932602
• Other study ID #: ABT-CIP-1020548
• Status: Recruiting
• Start date: October 31, 2023
• Est. completion date: October 2025

Study information

• Verified date: October 2023
• Source: Abbott Medical Devices
• Contact: Nicole Harbert
• Phone: 972-526-4841
• Email: nicole.harbert[@]abbott.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2812
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrythmia
• Bradycardia
• Cardiac Pacemaker

Intervention

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.

Locations

Country	Name	City	State
United States	Abbott	Sylmar	California

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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