IRB Study Number 25-226
Status Recruiting
Institute Heart and Vascular Institute
Description
The purpose of the clinical study is to obtain clinical data on the CardioMech Mitral Valve Repair System (MVRS) in patients diagnosed with moderate to severe (≥3+) or severe (≥4+), symptomatic, degenerative mitral regurgitation with prolapse or flail of the P2 leaflet segment, and who are determined to be at intermediate or high surgical risk for mitral valve repair, as assessed by the site’s multidisciplinary heart team. The aim of the CardioMech MVRS technology is to provide percutaneous placement of an implantable chord to repair prolapsed or flail mitral valve leaflet in patients with severe DMR due to prolapse or flail of the mitral leaflet. This technology is an alternative to other surgical or transcatheter mitral valve repair methods.
Inclusion Criteria
Patient is ≥ eighteen (18) years of age.
Patient is willing and capable of participating in all testing, assessments and follow-up clinic visits required in this clinical study. CONFIDENTIAL 10228, Rev K CardioMech MVRS EFS Investigational Study Protocol Page 4 of 92
Femoral vein access and transseptal catheterization are feasible with the CardioMech MVRS guide catheter as determined by the investigator.
Exclusion Criteria
Women who are pregnant, lactating, or planning to become pregnant during the clinical study. Women of child-bearing potential must have a negative pregnancy test result within two weeks prior to the procedure.
Patients with comorbidities, illnesses or social conditions may compromise their ability to comply with any study requirement.
Patient is currently participating or planning to participate in a study that, in the investigator’s or Screening Eligibility Committee’s opinion, may clinically affect this protocol’s study endpoints.
