An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
Recruiting now · Not applicable
Conditions studied: Mitral Regurgitation
In brief
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.
Key facts
- Study ID
- NCT04029337
- Run by
- HighLife SAS
- People needed
- 30
- Starts
- 2020-07-14
- Expected to finish
- 2030-12-01
- Last updated by the study team
- 2025-03-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
- 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 it is running
- Tucson Medical Center — Tucson, Arizona, United States (enrolling)
- Los Robles Regional Medical Center — Los Angeles, California, United States (enrolling)
- Piedmont Heart — Atlanta, Georgia, United States (enrolling)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
- Minneapolis Heart — Minneapolis, Minnesota, United States (enrolling)
- Montefiore Medical Center — New York, New York, United States (enrolling)
- Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
- Houston Methodist Hospital — Houston, Texas, United States (enrolling)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Chippenham Hospital Richmond — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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