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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04029337
Other study ID # HL-2019-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 14, 2020
Est. completion date December 2027

Study information

Verified date January 2024
Source HighLife SAS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 2027
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Transcatheter Mitral Valve Replacement
Minimally invasive transcatheter mitral valve implantation using the HighLife™ TMVR system

Locations

Country Name City State
United States Piedmont Heart Atlanta Georgia
United States Brigham and Women's Hospital Boston Massachusetts
United States Medical University of South Carolina Charleston South Carolina
United States Houston Methodist Hospital Houston Texas
United States Los Robles Regional Medical Center Los Angeles California
United States Minneapolis Heart Minneapolis Minnesota
United States Montefiore Medical Center New York New York
United States University of Pennsylvania Philadelphia Pennsylvania
United States Chippenham Hospital Richmond Richmond Virginia
United States Tucson Medical Center Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
HighLife SAS

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
at 30 days post procedure
Primary 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) at 30 days post procedure
Secondary 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
immediately after procedure
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