Aveir DR Real-World Evidence Post-Approval Study

Bradycardia Clinical Trial

Official title:

Aveir Dual-Chamber Leadless Pacemaker Real-World Evidence Post-Approval Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05935007
• Other study ID #: ABT-CIP-10454
• Status: Recruiting
• Start date: October 31, 2023
• Est. completion date: January 2030

Study information

• Verified date: February 2024
• 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 post-approval study is to evaluate the long-term safety of the dual-chamber Aveir DR leadless pacemaker using real-world evidence methods.

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 assess Aveir DR leadless pacemaker safety in a large patient population. The results from this study will provide long-term safety data for the Aveir dual chamber LP and the Aveir atrial LP to fulfill the Condition of Approval requirements for the Aveir DR device from FDA. Due to the RWE data collection methods used in this study, a central 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: 1805
• Est. completion date: January 2030
• Est. primary completion date: January 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Eligibility Criteria:

• Implanted with an Aveir DR leadless pacemaker
• Continuous enrollment in Medicare Part A and Part B for 12 months prior to implant and for -30 days after implant, except in the case of death within the 30-day period
• Ability to link with Medicare fee-for-service data

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 will be conducted 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 Free from Acute Aveir DR System-Related Complications	Freedom from key acute complications through 30 days post implant procedure	30 Days
Primary	Number of Subjects Free from Chronic Aveir DR System-Related Complications	Freedom from key chronic complications from 31 days through 5 years post implant procedure procedure	5 Years
Secondary	Number of Subjects Free from Individual Aveir DR Leadless Pacemaker-Related	Complication rate of the Aveir DR leadless pacemaker for key individual acute and chronic complications	5 Years
Secondary	Number of Subjects with End of Device Service Events	Care of subjects at the end of device service. End-of-device service is defined as any event prior to the 5-year follow-up period which results in the leadless pacemaker being explanted or deactivated, another CIED implanted, or death. All instances of the end-of-service will be summarized by event type and time to event.	5 Years