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

Mitral Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04029337
• Other study ID #: HL-2019-01
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

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