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Avalus Ultra Post-Approval Study (PAS)
NCT06506903 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06506903
The ClinicalTrials.gov registry entry for NCT06506903 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 190 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Cardiac Surgery, which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06506903 reports 15 study locations spanning 11 distinct geographic areas — top geographies include Texas, Georgia, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06506903?
The interventions under investigation include: Medtronic Avalus Ultra (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06506903?
This trial is sponsored by Medtronic Cardiac Surgery, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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