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
541 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 Functional Class II, III, or ambulatory IV
- Receiving maximally tolerated guideline-directed medical therapy including cardiac resynchronization therapy for at least 3 months
- Considered inoperable or high-risk for surgical mitral valve repair or replacement by a multidisciplinary Heart Team
- Not suitable for other approved percutaneous mitral repair therapies as determined by a multidisciplinary Heart Team
- Meet anatomical criteria for HighLife valve sizing confirmed by CT and transesophageal echocardiogram
You will not qualify if you...
- Mitral stenosis
- Rheumatic valve disease
- Severe calcifications of the mitral annulus or mitral leaflets
- Prior surgical or interventional treatment of the mitral valve
- Unsuitable anatomy for transapical access
- Unsuitable anatomy of the aorta or ilio-femoral vessels for transfemoral access
- Untreated clinically significant coronary artery disease requiring revascularization
- Left ventricular ejection fraction below 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 the procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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