An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System

Protocol Title:

An Early Feasibility Study of the HighLife 28mm Transcatheter Trans-Septal Mitral Valve Replacement System

Protocol # HL-2019-01, ver. 5.0

Phase: United States Early Feasibility Study

Investigational Devices:

The HighLife 28mm Trans-Septal Mitral Valve and its delivery systems. These devices compose the HighLife Trans-septal Mitral Valve Replacement (TSMVR) System.

• Size 28 mm TMV (CLARITY valve)
• Size 28 mm TMV-L (CLARITY large annulus valve/ LAV)

Intended Use: The HighLife TSMVR system is intended for the trans-septal access percutaneous mitral valve replacement in patients suffering from symptomatic moderate-severe or severe mitral regurgitation (MR) due to primary (degenerative) or secondary (functional) abnormality of the mitral valve.

Device Description:

The HighLife TSMVR system is composed of a Trans-Septal (Mitral Valve (TSMV), a sub-annular implant (SAI), and their delivery systems and accessories. The TMV is a 28 mm mitral bioprosthesis made of a self-expanding Nitinol frame covered with polyester graft and supporting bovine pericardium leaflets. The bioprosthesis is used in conjunction with the Sub-Annular Implant (SAI), comprising a ring (made of polycarbonate urethane (PCU), nitinol, gold markers and polyester (Dacron) to be placed around the mitral valve apparatus to stabilize the position of the mitral valve implant.

Design: A single arm, prospective, multicenter, non-randomized and open-labelled study.

Purpose: The purpose of the study is to evaluate the feasibility, safety and performance of the HighLife 28mm Trans-septal Mitral Valve Replacement (TSMVR) system in NYHA Class ≥ II-IV patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment or deemed more appropriate to receive transcatheter mitral valve replacement than to receive conventional mitral valve surgery according to the local multidisciplinary Heart Team.

Objectives: Primary objectives are to evaluate the feasibility, safety and performance of the HighLife 28mm TSMVR system at 30 days. Secondary objectives are to evaluate long term safety and performance of the HighLife TSMVR system.

Inclusion criteria

• Age ≥ 18 years
• Severe mitral regurgitation
• New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.
• Patient is under maximally tolerated GDMT (incl. CRT) for at least 3 months
• Multidisciplinary Heart Team consensus that the patient is inoperable or at high-risk for surgical repair/replacement due to significant co-morbid conditions
• Multidisciplinary Heart Team consensus that the patient is not a suitable candidate for other approved percutaneous repair therapy due to anatomical or medical conditions
• Patient meets the anatomical criteria for HighLife valve sizing as determined by CT and TEE

Main Exclusion Criteria:

• Mitral stenosis
• Rheumatic valve disease
• Severe calcifications of the mitral annulus and/or mitral leaflets
• Prior surgical or interventional treatment of the mitral valve
• Unsuitable anatomy for the transapical access
• Unsuitable anatomy of the aorta and ilio-femoral vessels for the transfemoral access
• Untreated clinically significant coronary artery disease requiring revascularization
• LVEF < 30%
• LVEDD > 70mm
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation
• Hypertrophic Obstructive Cardiomyopathy (HOCM)
• Any surgical or interventional procedure (including PCI) done in the past 30 days prior to procedure