HighFLO Study
Research type
Research Study
Full title
HighLife Trans-Septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY valve in patients with moderate-severe or severe mitral regurgitation, high surgical risk and with a high risk for Left Ventricular Outflow Tract Obstruction (LVOTO)
IRAS ID
299168
Contact name
David Hildick-Smith
Contact email
Sponsor organisation
Highlife SAS
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 3 months, 1 days
Research summary
Mitral regurgitation (MR) is one of the most common valvular heart diseases in an ageing population and in patients with heart failure in the USA and in Europe and affects almost 10% of individuals over 75 years of age. MR is associated with a poor prognosis in the absence of treatment. Until the last decade, therapeutic options were ranging from medical treatment to surgical mitral valve repair or replacement using a less invasive surgical option. However, nearly half of patients are not considered suitable for surgery due to the presence of comorbidities which increase the risk of surgery and new percutaneous approaches have then been developed. Although percutaneous repair devices present favourable safety, one of their drawbacks is the failure to eliminate MR completely. Since 2014, Transcatheter Mitral Valve Replacement (TMVR) has emerged as valuable treatment alternative.
However, implant of a mitral replacement valve in the mitral annulus may lead to obstruction of the left ventricular outflow tract (LVOTO) which might result in immediate flow obstruction leading to LV failure and/or reduction in forward flow and/or pressure reduction in the ascending aorta. Highlife has thus developed the Highlife CLARITY valve which has a reduced covering of the frame of the valve as it relates to the outflow tract.The purpose of the study is to evaluate the feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system 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).
This study is sponsored by HighLife SAS, based in France.
A total of 15 patients will be treated in the study at up to 15 hospitals across Europe and Australia. They will be involved for 5 years. The investigational sites will be selected based on previous (Highlife) experience/training, and/or significant experience in managing symptomatic MR patients, mitral surgery and transcatheter mitral valve treatment.REC name
HSC REC B
REC reference
21/NI/0116
Date of REC Opinion
19 Jul 2021
REC opinion
Favourable Opinion