EFS of the CardioMech MVRS
ConditionMitral Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCardioMech AS
About this trial
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
Eligibility criteria
Qualifiers
Eighteen (18) years of age or greater
Moderate to severe (≥3+) or severe (≥4+) mitral valve regurgitation (per American Society of Echocardiography (ASE) guidelines) due to mitral valve prolapse or flail
Intermediate or high surgical risk for mitral valve repair
Disqualifiers
History of rheumatic heart disease
History of prior endocarditis
History of prior repair or replacement of the mitral valve, or annuloplasty
Severely calcified mitral leaflet or has evidence of calcification in the grasping area of the leaflets that would prevent leaflet anchor positioning and deployment
Trial design
Treatments tested in this trial
- CardioMech MVRS
Treatment groups
25 Participants
are divided into 1 treatment groupLocations
12California
Cardiovascular Institute of Los Robles Health System91360, Thousand Oaks United States
Illinois
Northwestern University60208, Evanston United States
Kansas
Ascension St. Francis via Christi67226, Wichita United States
Minnesota
Mayo Clinic55902, Rochester United States
Sponsors and collaborators
CardioMech AS
Lead sponsor
Source ClinicalTrials.gov