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Avalus Ultra Post-Approval Study (PAS)

NCT06506903 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2026-04-21

No results posted yet for this 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

  • Aortic Valve Disease

Interventions

DEVICE

Medtronic Avalus Ultra

Surgical aortic valve replacement with the Medtronic Avalus Ultra bioprosthesis for management of aortic stenosis and regurgitation.

Sponsors & Collaborators

  • Medtronic Cardiac Surgery

    lead INDUSTRY

Principal Investigators

  • Juan Crestanello, MD · Mayo Clinic

  • Bo Yang, MD, PhD · University of Michigan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-20
Primary Completion
2026-11-30
Completion
2026-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06506903 on ClinicalTrials.gov