Aveir AR Coverage With Evidence Development (CED) Study

Arrhythmia Clinical Trial

— ARRIVE  

Official title:

Aveir AR Coverage With Evidence Development (CED) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06100770
• Other study ID #: ABT-CIP-CL1021378
• Status: Recruiting
• Start date: January 18, 2024
• Est. completion date: January 2031

Study information

• Verified date: January 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 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 586
• Est. completion date: January 2031
• Est. primary completion date: January 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmia
• Bradycardia
• Cardiac Pacemaker

Intervention

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

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 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
Primary	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	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
Secondary	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