Actively Recruiting
Aveir AR Coverage With Evidence Development (CED) Study
Led by Abbott Medical Devices · Updated on 2025-04-04
586
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and long-term health outcomes of the single-chamber Aveir Atrial Leadless Pacemaker device, also known as the Aveir20 AR LP system. This coverage with evidence development (CED) study focuses on Medicare patients implanted with this device or a similar single-chamber atrial transvenous pacemaker from any manufacturer. The study uses real-world evidence by merging multiple data sources from Abbott and the Center for Medicare Services to better understand device-related complications and survival rates. This observational study collects data without requiring any new device intervention. It includes two groups: patients implanted with the Aveir AR Leadless Pacemaker and those with a single-chamber atrial transvenous pacemaker, serving as a comparison group. Both groups' data come from real-world healthcare records, allowing researchers to assess outcomes over time without affecting patient treatment. Participants' health data will be monitored for complications within 30 days and up to two years, including acute and chronic device-related issues and any need for device re-intervention. The study uses Medicare claims data and does not require individual patient consent due to an approved waiver. Outcomes such as survival rates and complication frequencies are tracked to understand device performance in real-world use, with the study planned to continue through January 2031.
CONDITIONS
Brief Title
Aveir AR Coverage With Evidence Development (CED) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Medicare beneficiaries implanted with an Aveir AR leadless pacemaker on or after the study start date
- Medicare beneficiaries implanted with a single-chamber atrial transvenous pacemaker system on or after the study start date
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 years
Participants who undergo routine care with an Aveir AR Leadless Pacemaker or a single-chamber atrial transvenous pacemaker system are observed using real-world data to assess health outcomes.
Trial Site Locations
Total: 1 location
1
Abbott
Sylmar, California, United States, 91342
Actively Recruiting
Research Team
N
Nicole Harbert
S
Stephanie Delgado
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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