Status:
RECRUITING
An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
Lead Sponsor:
HighLife SAS
Conditions:
Mitral Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
Protocol Title: An Early Feasibility Study of the HighLife 28mm Transcatheter Trans-Septal Mitral Valve Replacement System Protocol # HL-2019-01, ver. 5.0 Phase: United States Early Feasibility Stu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04029337
Start Date
July 14 2020
End Date
December 1 2030
Last Update
March 17 2025
Active Locations (10)
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1
Tucson Medical Center
Tucson, Arizona, United States, 85712
2
Los Robles Regional Medical Center
Los Angeles, California, United States, 91360
3
Piedmont Heart
Atlanta, Georgia, United States, 30309
4
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115