Trials / Completed
CompletedNCT05784337
Mi-thos® Transcatheter Mitral Valve Replacement(First-in-Man Study)
Evaluation of the Efficacy and Safety of the Mi-thos® Transcatheter Mitral Valve Replacement System in Patients With Severe Mitral Valve Disease at High Surgical Risk(First-in-Man Study)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- Shanghai NewMed Medical Co., Ltd. · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the effectiveness and safety of the Mi-thos® Transcatheter Mitral Valve Replacement System in the treatment of patients with moderate or greater mitral regurgitation who are at high risk for conventional surgery, or who are not candidates for conventional surgery.
Detailed description
The Mi-thos® study is a single-arm, prospective, safety and performance clinical study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Mi-thos® Transcatheter Mitral Valve Replacement System | Transcatheter Mitral Valve Replacement |
Timeline
- Start date
- 2021-04-21
- Primary completion
- 2023-01-10
- Completion
- 2023-01-10
- First posted
- 2023-03-24
- Last updated
- 2023-03-24
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05784337. Inclusion in this directory is not an endorsement.