Trials / Active Not Recruiting
Active Not RecruitingNCT06506903
Avalus Ultra Post-Approval Study (PAS)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 190 (actual)
- Sponsor
- Medtronic Cardiac Surgery · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
A prospective, multi-center, single-arm, interventional, non-randomized, post-market study to characterize the safety and effectiveness of the Medtronic Avalus Ultra aortic valve bioprosthesis in patients with aortic valve disease. Approximately 150 subjects in the United States will be implanted and followed through one year post-procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Medtronic Avalus Ultra | Surgical aortic valve replacement with the Medtronic Avalus Ultra bioprosthesis for management of aortic stenosis and regurgitation. |
Timeline
- Start date
- 2024-11-20
- Primary completion
- 2026-11-01
- Completion
- 2026-11-01
- First posted
- 2024-07-18
- Last updated
- 2025-12-17
Locations
15 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06506903. Inclusion in this directory is not an endorsement.