AMEND TS Early Feasibility Study (NCT06951672) | Clinical Trial Compass
RecruitingNot Applicable
AMEND TS Early Feasibility Study
United States15 participantsStarted 2025-09-11
Plain-language summary
Valcare Medical AMEND Trans-Septal System is a mitral valve repair annuloplasty ring implanted in a trans-catheter method intended for correction of mitral regurgitation. It is designed to be used as standalone therapy or in combination with other repair treatments.
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. Patient age \>21
✓. The patient will benefit from isolated mitral valve annuloplasty for mitral regurgitation without the need for concomitant cardiovascular surgical procedures such as coronary artery bypass or another valve reconstruction or replacement
✓. Symptomatic functional MR≥3+
✓. NYHA functional capacity ≥2
✓. LV Ejection Fraction \> 30%, LVEDD \< 68 mm
✓. The subject meets the anatomical eligibility criteria for available implant size(s)
✓. The subject is at high risk for mitral valve surgery as assessed by the center's heart team for mitral procedures.
✓. The subject has been stable and on a stable pharmacological regimen for heart failure for at least 1 month prior to inclusion
Exclusion criteria
✕. The patient has mitral incompetence where an annuloplasty ring will not contribute to its repair
✕. Cardiac or non-cardiac major or progressive disease, which in the investigator's discretion produces an unacceptable increased risk to the patient.
✕. Life expectancy of less than 12 months
✕. The subject is non-operable and is not eligible for TEER, to allow bailout
✕
What they're measuring
1
Safety Endpoint: Composite of death (all-cause), stroke, myocardial infarction (MI), or non-elective cardiovascular surgery for device related complications at 30 days.