Aveir VR Coverage With Evidence Development Post-Approval Study

Bradycardia Clinical Trial

— CED  

Official title:

Aveir Single-Chamber Leadless Pacemaker Coverage With Evidence Development (ACED) Post-Approval Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05336877
• Other study ID #: ABT-CIP-10426
• Status: Recruiting
• Start date: June 21, 2022
• Est. completion date: January 1, 2028

Study information

• Verified date: July 2023
• Source: Abbott Medical Devices
• Contact: Grant Kim
• Phone: 818-493-3147
• Email: Grant.kim1[@]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 single-chamber Aveir Single-Chamber Leadless Pacemaker device (Aveir VR LP).

Description:

This is a non-randomized, multi-center study leveraging real-world evidence methods that merge multiple real-world datasets from Abbott and the Center for Medicare Services to compare Aveir VR LP safety and health outcomes to those in patients implanted with single-chamber transvenous pacemakers in a large patient population. The study will enroll all Medicare patients implanted with the Aveir VR LP and, as the control group, patients implanted with a single-chamber ventricular transvenous pacemaker from any manufacturer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8744
• Est. completion date: January 1, 2028
• Est. primary completion date: January 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

The study cohort will include all Medicare patients with continuous claims data implanted with an Aveir VR leadless pacemaker or a full-system single-chamber ventricular transvenous pacemaker (from any manufacturer) in any US location Inclusion Criteria: Medicare beneficiaries implanted with an Aveir VR leadless pacemaker on or after the study start date (i.e., the date of Aveir VR market approval) will be included in the study. OR Medicare beneficiaries implanted with a full system (e.g. lead and generator) single-chamber ventricular transvenous pacemaker on or after the study start date Exclusion Criteria: None

Related Conditions & MeSH terms

• Arrythmia
• Bradycardia
• Cardiac Pacemaker

Intervention

Device:
• Aveir VR Leadless Pacemaker System
This study will utilize real-world data from patients implanted with the Aveir VR Leadless Pacemaker System. No device intervention is required in this study.
• Single-Chamber Transvenous Pacemaker
This study will utilize real-world data from patients implanted with a single-chamber transvenous pacemaker as a comparator to the Aveir VR 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	Number of Subjects with Acute Device-Related Complications	Rate of acute complications in subjects implanted with an Aveir VR LP compared to subjects implanted with a single-chamber ventricular transvenous pacemaker. Acute complications are defined as a peri-procedural, device-related adverse event within 30 days post-implant.	30 days
Primary	Number of Subjects Alive after 2 Years	The 2-year survival rate of subjects implanted with an Aveir VR LP compared with subjects implanted with single-chamber ventricular transvenous pacemaker.	2 years
Secondary	Number of Subjects with Chronic Device-Related Complications	Rate of chronic complications in subjects implanted with Aveir VR LP compared with subjects implanted with a single-chamber ventricular transvenous pacemaker, from 31 days through six months post implant procedure. A chronic complication is defined as a post-procedural, device-related adverse event that requires invasive intervention to resolve.	6 months
Secondary	Number of Subjects with a Device-Related Re-Intervention	Rate of device-related re-intervention in subjects implanted with an Aveir VR LP compared to subjects implanted with a single-chamber ventricular transvenous pacemaker, through 2 years post implant procedure.	2 years