Trials / Recruiting
RecruitingNCT04029363
Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- HighLife SAS · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
to evaluate the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | HighLife Transcatheter Mitral Valve Replacement | Transcatheter Mitral Valve Replacement |
Timeline
- Start date
- 2019-05-28
- Primary completion
- 2026-12-15
- Completion
- 2031-12-15
- First posted
- 2019-07-23
- Last updated
- 2025-09-15
Locations
50 sites across 7 countries: Australia, Belgium, France, Germany, Poland, Singapore, United Kingdom
Source: ClinicalTrials.gov record NCT04029363. Inclusion in this directory is not an endorsement.