Trials / Recruiting
RecruitingNCT04195984
Mi-thos® Transcatheter Mitral Valve Replacement 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.
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 122 (estimated)
- Sponsor
- Shanghai NewMed Medical Co., Ltd. · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System.
Detailed description
The Mi-thos® study is an multicenter, single-arm, prospective, safety and performance clinical study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Mi-thos® valve and transapical delivery system | Transcatheter mitral valve replacement system |
Timeline
- Start date
- 2021-03-25
- Primary completion
- 2026-05-01
- Completion
- 2027-01-01
- First posted
- 2019-12-12
- Last updated
- 2025-02-13
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04195984. Inclusion in this directory is not an endorsement.