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

Last updated: March 12, 2025
Sponsor: HighLife SAS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mitral Valve Regurgitation

Congestive Heart Failure

Treatment

HighLife Transcatheter Mitral Valve Replacment

Transcatheter Mitral Valve Replacement

Clinical Study ID

NCT04029337
HL-2019-01
  • Ages > 18
  • All Genders

Study Summary

Study to evaluate the feasibility, safety and performance of the HighLife trans-septal Transcatheter Mitral Valve in patients with moderate-severe and severe mitral regurgitation who are at high risk for surgical treatment.

Eligibility Criteria

Inclusion

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 athigh-risk for surgical repair/replacement due to significant co-morbid conditions

  • Multidisciplinary Heart Team consensus that the patient is not a suitable candidatefor other approved percutaneous repair therapy due to anatomical or medicalconditions

  • Patient meets the anatomical criteria for HighLife valve sizing as determined by CTand TEE

Exclusion

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 daysprior to procedure

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: HighLife Transcatheter Mitral Valve Replacment
Phase:
Study Start date:
July 14, 2020
Estimated Completion Date:
December 31, 2030

Study Description

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.

Connect with a study center

  • Tucson Medical Center

    Tucson, Arizona 85712
    United States

    Active - Recruiting

  • Los Robles Regional Medical Center

    Los Angeles, California 91360
    United States

    Active - Recruiting

  • Piedmont Heart

    Atlanta, Georgia 30309
    United States

    Active - Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Minneapolis Heart

    Minneapolis, Minnesota 55407
    United States

    Active - Recruiting

  • Montefiore Medical Center

    New York, New York 10467
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Terminated

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Chippenham Hospital Richmond

    Richmond, Virginia 23225
    United States

    Terminated

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