Clinical trial NCT04029337: An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
Official title: An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mitral Regurgitation
Lead sponsor: HighLife SAS
Sponsor class: INDUSTRY
First posted: 2019-07-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Freedom of major adverse events
timeFrame: at 30 days post procedure
measure: Continued intended performance of the HighLife™ bioprosthesis
timeFrame: at 30 days post procedure
Secondary outcomes:
measure: Technical success
timeFrame: immediately after procedure
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Tucson Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: Los Robles Regional Medical Center
state: California
city: Atlanta
country: United States
facility: Piedmont Heart
state: Georgia
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: Minneapolis Heart
state: Minnesota
city: New York
country: United States
facility: Montefiore Medical Center
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Richmond
country: United States
facility: Chippenham Hospital Richmond
state: Virginia
Study officials:
References: