Transcatheter Mitral Valve Replacement for Severe Mitral Regurgitation
An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
This study is testing a new heart valve replacement method to see if it can help people with severe mitral regurgitation who are at high risk for surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | HighLife SAS Industry-sponsored |
| Locations | 10 sites (Tucson, Arizona and 9 other locations) |
| Trial ID | NCT04029337 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility, safety, and performance of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System in patients with moderate-severe and severe mitral regurgitation who are at high risk for surgical treatment. It is a single-arm, prospective, multicenter, non-randomized, and open-label study. The investigational device includes a self-expanding mitral bioprosthesis and a sub-annular implant designed to stabilize the valve position. Patients will be assessed for eligibility based on specific anatomical and medical criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with severe mitral regurgitation who are considered inoperable or at high risk for surgical intervention.
Not a fit: Patients with mitral stenosis, rheumatic valve disease, or unsuitable anatomy for the procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive treatment option for patients with severe mitral regurgitation who are not candidates for traditional surgery.
How similar studies have performed: Other studies have explored transcatheter approaches for mitral valve replacement, showing promising results, but this specific device and methodology are relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tucson, Arizona and 9 other locations
- Tucson Medical Center — Tucson, Arizona, United States (Recruiting)
- Los Robles Regional Medical Center — Los Angeles, California, United States (Recruiting)
- Piedmont Heart — Atlanta, Georgia, United States (Recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Minneapolis Heart — Minneapolis, Minnesota, United States (Recruiting)
- Montefiore Medical Center — New York, New York, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Terminated)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- Houston Methodist Hospital — Houston, Texas, United States (Recruiting)
- Chippenham Hospital Richmond — Richmond, Virginia, United States (Terminated)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.