Actively Recruiting
An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
Led by HighLife SAS · Updated on 2025-03-17
30
Participants Needed
10
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement (TSMVR) system in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgery. This early feasibility study focuses on assessing the device's feasibility, safety, and performance, especially in patients with symptomatic mitral valve abnormalities who cannot undergo conventional surgery. The study is open-label, prospective, and conducted across multiple centers in the United States. The study uses the HighLife TSMVR system, which includes a 28 mm self-expanding mitral bioprosthesis with bovine pericardium leaflets and a sub-annular implant to stabilize the valve position. The device is delivered through a minimally invasive trans-septal approach. Patients receive this single-arm investigational treatment, designed as an alternative when medical therapy is maximized, and surgery is high-risk or unsuitable. The study evaluates the device mainly at 30 days post-procedure, with longer-term safety and performance also monitored. Participants will undergo assessments including imaging tests like CT and transesophageal echocardiography to confirm valve sizing and anatomy before treatment. After the procedure, researchers will monitor for major adverse events and the device's ongoing performance. The primary outcomes focus on safety and function at 30 days, while technical success is assessed immediately after implantation. The study's total duration extends through long-term follow-up to observe sustained outcomes and safety, with careful monitoring throughout the process.
CONDITIONS
Brief Title
An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Severe mitral regurgitation
- New York Heart Association (NYHA) Functional Class II, III, or ambulatory IV
- Patient has been under maximally tolerated guideline-directed medical therapy including cardiac resynchronization therapy for at least 3 months
- Multidisciplinary Heart Team consensus that the patient is inoperable or at high risk for surgical repair or replacement due to significant co-morbid conditions
- Multidisciplinary Heart Team consensus that the patient is not suitable for other approved percutaneous repair therapy due to anatomical or medical conditions
- Patient meets anatomical criteria for HighLife valve sizing as determined by CT and transesophageal echocardiography
You will not qualify if you...
- 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 transapical access
- Unsuitable anatomy of the aorta and ilio-femoral vessels for transfemoral access
- Untreated clinically significant coronary artery disease requiring revascularization
- Left ventricular ejection fraction less than 30%
- Left ventricular end-diastolic diameter greater than 70 mm
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
- Hypertrophic obstructive cardiomyopathy
- Any surgical or interventional procedure including percutaneous coronary intervention within 30 days prior to procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a minimally invasive transcatheter mitral valve replacement using the HighLife 28mm Trans-Septal Mitral Valve Replacement System.
1 procedure visit (in-person)
Duration - 30 days
Participants are monitored for safety and performance of the valve replacement after the procedure.
Multiple visits during 30 days post procedure
Trial Site Locations
Total: 10 locations
1
Tucson Medical Center
Tucson, Arizona, United States, 85712
Actively Recruiting
2
Los Robles Regional Medical Center
Los Angeles, California, United States, 91360
Actively Recruiting
3
Piedmont Heart
Atlanta, Georgia, United States, 30309
Actively Recruiting
4
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
5
Minneapolis Heart
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
6
Montefiore Medical Center
New York, New York, United States, 10467
Actively Recruiting
7
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Terminated
8
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
9
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
10
Chippenham Hospital Richmond
Richmond, Virginia, United States, 23225
Terminated
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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