Epicardial Mitral Touch System for Mitral Insufficiency
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorMitre Medical Corp.
About this trial
To evaluate the safety and performance of the Mitral Touch System to treat mitral insufficiency in patients who are to undergo cardiac surgery with either a sternotomy or thoracotomy who present with moderate to severe ischemic or functional mitral regurgitation.
Eligibility criteria
Qualifiers
Moderate or greater (2+) ischemic
Functional Mitral regurgitation by 2D echocardiography using an integrative method
Patient is scheduled for cardiac surgery (e.g. CABG including patients on the waiting list for Heart Transplantation)
Patient is 22 years of age or older
Disqualifiers
Any evidence of structural (chordal or leaflet) mitral valve disease
Inability to derive ERO, LVESVI or LVEDVI by TTE
Prior surgical or percutaneous mitral valve intervention
Contraindication to cardiopulmonary bypass (CPB)
Trial design
Treatments tested in this trial
- Implant an epicardial device to reshape the mitral valve annulus
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Mitre Medical Corp.
Lead sponsor
BSWRI Cardiac Imaging Core Lab (CICL)
Collaborator
Source ClinicalTrials.gov