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HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve — HighFLO  

Mitral Regurgitation Clinical Trial

Official title:
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)

Clinical Trial Summary

Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04888247
Study type Interventional
Source HighLife SAS
Contact Luc Verhees
Phone +31 6 4270 2457
Email lverhees@highlifemed.com
Status Recruiting
Phase N/A
Start date July 1, 2021
Completion date February 1, 2030
View Details
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