Aveir AR Coverage With Evidence Development (CED) Study
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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).
Eligibility
Primary outcome measure(s)
- Acute device-related complication rate — 30 days
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. - Two-year survival rate — 2 years
Assess (2-year) survival rate of subjects implanted with an Aveir AR LP, compared to single chamber atrial transvenous pacemakers.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Abbott | Sylmar | California | Recruiting |
More Abbott Medical Devices trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06100770 on ClinicalTrials.gov ↗ ← All trials in the USA