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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
CardioMech MVRS
DeviceCardioMech MVRS
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: CardioMech Mitral Valve Repair System (MVRS)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure
Time frame
30 days2
Change in MR grade
Time frame
30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov