CorMatrix Cor TRICUSPID ECM Valve Replacement Study
ConditionTricuspid Valve Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-85
SponsorCorvivo Cardiovascular, Inc.
About this trial
The Pivotal Study of the Cor TRICUSPID ECM Valve (or Cor PEDIATRIC Tricuspid ECM Valve). This study follows the EFS and is now to determine the safety and efficacy of the Cormatrix Cor TRICUSPID Valve for any patients requiring surgical replacement of the tricuspid valve.
Eligibility criteria
Qualifiers
Patient with a regurgitant or absent tricuspid valve requiring surgical treatment including those patients having concomitant cardiac procedures
Male or female
Patient/authorized legal guardian understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provides written informed consent and the pediatric patient (if applicable) provides written assent (if able) prior to procedure
Patient/patient's authorized legal guardian is geographically stable (or willing to return for required study follow-up) and understands and is willing to fulfill all of the expected requirements of this clinical protocol
Disqualifiers
Tricuspid annulus too small (< 10mm) to accommodate the Cor Tricuspid ECM Valve
Left ventricular ejection fraction (LVEF) < 25%
Mean pulmonary pressure > 50mm Hg or pulmonary vascular resistance greater than 6 Woods Units
Emergency cardiac procedure. An example would be a person requiring resuscitation and in cardiogenic shock. An unscheduled or unplanned emergency surgery
Trial design
Treatments tested in this trial
- CorMatrix Cor TRICUSPID ECM Valve
Treatment groups
78 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov