Trials / Not Yet Recruiting
Not Yet RecruitingNCT05991271
Venus-Vitae Pivotal Study Smart-Align Study
Multicenter Pivotal Study to Evaluate the Treatment of Severe Aortic Valve Stenosis With Next-Generation Venus-Vitae Transcatheter Heart Valve (THV) System
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Venus MedTech (HangZhou) Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose is to evaluate the safety, effectiveness and performance of Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis.
Detailed description
This trial is a prospective, multi-center, non-randomized interventional study to evaluate the safety, effectiveness and performance of the Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis. Clinical visits will be scheduled at screening, pre-discharge, 30 days, 6 months, 12 months and annually thereafter to 5 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Venus-Vitae Transcatheter Heart Valve System | The Venus-Vitae THV is comprised of balloon-expandable and radiopaque cobalt-chromium alloy frame, porcine pericardium tri-leaflet, porcine pericardium inner skirt, polyurethane outer skirt, PTFE assembly sutures, and three radiopaque gold markers (Figure 1). The valve utilizes Venus Endura technology and stored in a non-aqueous condition. |
Timeline
- Start date
- 2023-10-31
- Primary completion
- 2024-12-31
- Completion
- 2029-06-30
- First posted
- 2023-08-14
- Last updated
- 2023-08-18
Source: ClinicalTrials.gov record NCT05991271. Inclusion in this directory is not an endorsement.