RecruitingNot ApplicableNCT04029337
An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
Sponsor
HighLife SAS
Enrollment
30 participants
Start Date
Jul 14, 2020
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria7
- 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
Exclusion Criteria12
- 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
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Interventions
DEVICETranscatheter Mitral Valve Replacement
Minimally invasive transcatheter mitral valve implantation using the HighLife™ TMVR system
Locations(10)
View Full Details on ClinicalTrials.gov
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NCT04029337
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