Trials / Active Not Recruiting
Active Not RecruitingNCT04836897
PrizValve® Transcatheter Aortic Valve Replacement Study
Evaluation of the Efficacy and Safety of the Transcatheter Aortic Valve Replacement System in Patients With Severe Aortic Valve Stenosis Disease at High Surgical Risk
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Shanghai NewMed Medical Co., Ltd. · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not suitable for surgery.
Detailed description
This study is an multicenter, single-arm, prospective, safety and performance clinical study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PrizValve® valve and transapical delivery system | Transcatheter aortic valve replacement system |
Timeline
- Start date
- 2021-01-19
- Primary completion
- 2023-06-19
- Completion
- 2028-06-01
- First posted
- 2021-04-08
- Last updated
- 2023-11-15
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04836897. Inclusion in this directory is not an endorsement.