HighLife™ Transcatheter Mitral Valve Replacement System Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-20

Study Completion Date

2024-01-16

Brief Summary

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Multicenter feasibility study of the HighLife™ TMVR system.

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Detailed Description

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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.

Conditions

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Mitral Valve Regurgitation Mitral Valve Insufficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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transcatheter mitral valve replacement

HighLife TMVR System is a novel and innovative approach developed as an alternative treatment for severe MR when medical treatment is maximal and surgical interventions not possible or at high risk. The HighLife TMVR system is composed of a Transcatheter Mitral Valve (TMV), a sub-annular implant (SAI), and their delivery systems and loading tools. The HighLife Valve is a 31 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).

Group Type EXPERIMENTAL

Transcatheter Mitral Valve Replacement

Intervention Type DEVICE

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

Interventions

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Transcatheter Mitral Valve Replacement

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

Intervention Type DEVICE

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No