HL-2018-01-TS Feasibility: EU/AU (v3.0)
Research type
Research Study
Full title
Feasibility 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
IRAS ID
260418
Contact name
Elodie Trouche
Contact email
Sponsor organisation
Highlife SAS
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CIV-PL-19-10-030084, EUDAMED unique study ID ; HL-2018-01-TS:Feasibility EU/AU, Full protocol number for above
Duration of Study in the UK
6 years, 0 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. A less invasive surgical option has now become well-established. However, nearly half of patients are not considered suitable for surgery due to the presence of comorbidities which increase the risk of surgery. New percutaneous approaches have then been developed to address this unmet clinical need. 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 by providing a new valve, which when implanted correctly eliminates MR completely.
The HighLife 28mm Transcatheter Mitral Valve is a novel TMVR device, not CE-marked, developed as alternative percutaneous treatment of MR using a trans-septal access route.
The purpose of this clinical study is to evaluate the feasibility, safety and performance of the HighLife 28mm Transcatheter Mitral Valve and its delivery systems in NYHA Class ≥ II-IV patients with moderate-severe or severe MR who are at high risk for surgical treatment according to the local multidisciplinary Heart Team decision. This is a single arm, prospective, multicentre, non-randomized, open-labelled study.
This study is sponsored by HighLife SAS, based in France.
A total of 50 patients will be treated in the study at up to 30 hospitals across Europe and Australia. They will be involved for 5 years. The investigational sites have been selected based on significant experience in managing symptomatic MR patients, mitral surgery and transcatheter mitral valve treatment.REC name
HSC REC B
REC reference
20/NI/0004
Date of REC Opinion
21 Feb 2020
REC opinion
Further Information Favourable Opinion