HighLife™ Transcatheter Mitral Valve Replacement System Study

HighLife SAS5 enrolled

Overview

Multicenter feasibility study of the HighLife™ TMVR system.

This is an exploratory clinical study designed to evaluate the feasibility, safety and performance of the Highlife TMVR System in a population of patients with severe symptomatic mitral regurgitation, who are not suitable for surgical or approved percutaneous treatments according to the judgement of the Heart Team. The data gathered in this study will allow to evaluate the feasibility of mitral replacement using the HighLife™ TMVR system and characterize the safety and performance profile of the HighLife™ TMVR System. All patients will be followed periodically up to 12 months after the intervention and long term safety and performance will be collected annually up to 5 years.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mitral Valve Regurgitation Mitral Valve Insufficiency

Interventions

Transcatheter Mitral Valve ReplacementDEVICE

Minimally invasive transcatheter mitral valve implantation using the HighLife™ TMVR system

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

CHRU Lille

Lille, France

Hôpital Privé Jacques Cartier

Massy, France

CHU Nantes

Nantes, France

Groupe Hospitalier Pitié-Salpétrière Institut de Cardiologie

Paris, France

Outcomes

Primary Outcomes

Freedom of major adverse events

including: * All-cause mortality * Myocardial infarction or coronary ischemia requiring PCI or CABG * Major stroke * Life-threatening bleeding (MVARC scale) * Major access and vascular complications * Stage 2 or 3 acute kidney injury (includes dialysis) * Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention * Severe hypotension, heart failure or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for ≥ 48H

Time frame: at 30 days post procedure

Continued intended performance of the HighLife™ bioprosthesis

defined as the reduction of mitral regurgitation (MR) to either optimal (0+ to trace) or acceptable (reduced by at least 1 grade from baseline with no more than 2+ MR) without significant mitral stenosis (post-procedure EOA ≥ 1.5 cm2 with a transmitral gradient \< 5mmHg) and with no greater than mild (1+) paravalvular MR (and without associated hemolysis)

Time frame: at 30 days post procedure

Technical success

defined as alive patient at exit from procedure room, with all of the following: * Successful access, delivery and retrieval of the HighLife delivery systems * Deployment and correct positioning of the HighLife bioprosthesis * Freedom of additional emergency surgery or re-intervention related to the device or access procedure

Time frame: immediately after procedure

Secondary Outcomes

Device Success (per MVARC definitions)

per MVARC definition

Time frame: At 30 days, 6 months and 12 months post procedure

Procedure Success

per MVARC definition

Data from ClinicalTrials.gov

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