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

NCT04029337 | Recruiting DMC FDA Device

• 1 other identifier: HL-2019-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 10

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.

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Technical success

  immediately after procedure

Study Arms (1)

Transcatheter Mitral Valve Replacement

EXPERIMENTAL

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.

Device: Transcatheter Mitral Valve Replacement

Interventions

Transcatheter Mitral Valve Replacement DEVICE

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

Transcatheter Mitral Valve Replacement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HighLife SAS: lead

Study Sites (10)

Tucson Medical Center

Tucson, Arizona, 85712, United States

RECRUITING

Los Robles Regional Medical Center

Los Angeles, California, 91360, United States

RECRUITING

Piedmont Heart

Atlanta, Georgia, 30309, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Minneapolis Heart

Minneapolis, Minnesota, 55407, United States

RECRUITING

Montefiore Medical Center

New York, New York, 10467, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

TERMINATED

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

Chippenham Hospital Richmond

Richmond, Virginia, 23225, United States

TERMINATED

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2019
• First Posted: July 23, 2019
• Study Start: July 14, 2020
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)