Trials / Recruiting
RecruitingNCT04888247
HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve
HighLife TSMVR Feasibility Study of the Open Cell CLARITY Valve in Patients With Moderate-severe or Severe MR, High Surgical Risk and With a High Risk for Left Ventricular Outflow Tract Obstruction (LVOTO)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- HighLife SAS · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system
Detailed description
Study to assess the feasibility, safety, and performance of the HighLife CLARITY TSMV, and its deliver systems, in NYHA Class ≥ II-IV patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment according to the local multidisciplinary Heart Team decision, and who are at high risk for potential LVOT obstruction(LVOTO).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CLARITY | Trans-septal mitral valve replacement |
Timeline
- Start date
- 2021-07-01
- Primary completion
- 2025-12-01
- Completion
- 2031-02-01
- First posted
- 2021-05-17
- Last updated
- 2024-10-03
Locations
14 sites across 6 countries: Australia, Belgium, France, Germany, Poland, United Kingdom
Source: ClinicalTrials.gov record NCT04888247. Inclusion in this directory is not an endorsement.