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NCT06506903 · ClinicalTrials.gov registry record · NA
Avalus Ultra Post-Approval Study (PAS)
A NA study of Aortic Valve Disease, sponsored by Medtronic Cardiac Surgery.
- Active
- Registry status
- NA
- Development phase
- 190
- Enrollment target
- 15
- Study locations
NCT06506903: Active NA study of Aortic Valve Disease, sponsored by Medtronic Cardiac Surgery.
NCT06506903 is a NA study of Aortic Valve Disease that is active but no longer recruiting, run by Medtronic Cardiac Surgery. The registered enrollment target is 190 participants, below the 18,604-participant average among 15 other Aortic Valve Disease trials with a reported enrollment target (99% lower). The trial reports 15 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06506903, a NA study of Aortic Valve Disease, is active but no longer recruiting, sponsored by Medtronic Cardiac Surgery.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 190 participants
- Enrollment target
- 15
- Study locations
Study Summary
The purpose of this study is to characterize the safety and effectiveness of the Medtronic Avalus Ultra aortic valve bioprosthesis in patients with aortic valve disease.
Primary Outcome
Safety of the valve is evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events are evaluated in this study: thromboembolism, valve thrombosis, hemorrhage, paravalvular leak, endocarditis, structural valve deterioration, non-structural valve dysfunction, reintervention, death. This safety endpoint is descriptive, and no statistical hypothesis testing will be performed. The primary analysis of safety endpoint events will occur o
Conditions Studied
Interventions
- DEVICE Medtronic Avalus Ultra
Study Locations (15)
Texas
- Heart Hospital of Austin - Austin
- CHI Saint Lukes Health - Baylor Saint Lukes Medical Center - Houston
- Houston Methodist Hospital - Houston
Georgia
- Emory Saint Joseph's - Atlanta
- WellStar Kennestone Hospital - Marietta
Ohio
- UH Cleveland Medical Center - Cleveland
- ProMedica Toledo Hospital - Toledo
Connecticut
- Hartford Hospital - Hartford
Florida
- University of Florida Shands - Gainesville
Illinois
- Northwestern Memorial Hospital - Chicago
Michigan
- University of Michigan Health System - University Hospital - Ann Arbor
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2024-11-20 |
| Est. Completion | 2026-11 |
| Phase | NA |
What the registry record for NCT06506903 still lists
NCT06506903 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, below the 18,604-participant average among 15 other Aortic Valve Disease trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Aortic Valve Disease appearing as the primary indexed condition, and to 1 intervention - of which Medtronic Avalus Ultra is the first listed.
NCT06506903 lists 15 locations in 11 states (Texas, Georgia, Ohio).
Frequently Asked Questions
What is clinical trial NCT06506903 about?
NCT06506903 is a clinical study titled "Avalus Ultra Post-Approval Study (PAS)". The purpose of this study is to characterize the safety and effectiveness of the Medtronic Avalus Ultra aortic valve bioprosthesis in patients with aortic valve disease.
What is the current status of trial NCT06506903?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 190 participants. The study started on 2024-11-20. Estimated completion is 2026-11.
What conditions does trial NCT06506903 study?
This clinical trial studies the following conditions: Aortic Valve Disease.
What interventions are being tested in trial NCT06506903?
The interventions under investigation include: Medtronic Avalus Ultra (DEVICE).
Who is sponsoring clinical trial NCT06506903?
This trial is sponsored by Medtronic Cardiac Surgery, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06506903 being conducted?
This trial has 15 study locations across Connecticut, Florida, Georgia, Illinois, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06506903's enrollment target sits among peer trials
190 8th of 15 higher than 8 of 15 other Aortic Valve Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic Valve Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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