Trials / Active Not Recruiting
Active Not RecruitingNCT03924661
SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy
A Single Arm, Non-randomized, Multi-center Clinical Study of the SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (estimated)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This PAS is an observational, non-randomized, multi-center, single arm, clinical study to evaluate long term safety and effectiveness of the SJM™ Masters Series Hemodynamic Plus (HP) 15mm aortic mechanical heart valve (15 AHPJ-505) as a replacement device for pediatric patients with a diseased, damaged, or malfunctioning aortic valve.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Aortic Valve Replacement | SJM™ Masters Series Hemodynamic Plus (HP) 15mm aortic mechanical heart valve as a replacement device for patients with a diseased, damaged, or malfunctioning aortic valve |
Timeline
- Start date
- 2019-10-24
- Primary completion
- 2026-06-01
- Completion
- 2028-10-01
- First posted
- 2019-04-23
- Last updated
- 2026-04-13
Locations
13 sites across 2 countries: United States, Germany
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03924661. Inclusion in this directory is not an endorsement.