CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorCorvivo Cardiovascular, Inc.
About this trial
The goal of this pivotal study is to demonstrate the safety and performance of the Cor TRICUSPID ECM (extracellular matrix) Valve (or Cor PEDIATRIC Tricuspid ECM Valve) for the surgical management of tricuspid valve disease and dysfunction in adult and pediatric patients. The main question(s) it aims to answer are:
* whether the device may be implanted successfully and safely, and * whether the device effectively treats tricuspid valve disease and dysfunction through 12 months
Participants will undergo:
* preoperative evaluation * tricuspid valve replacement with the Cor TRICUSPID ECM Valve * postoperative evaluation, including at hospital discharge, 30 days, 6 months, and 12 months, and then annually thereafter through 5 years
Eligibility criteria
Qualifiers
Patient with a regurgitant or absent tricuspid valve requiring surgical treatment including those patients having concomitant cardiac procedures
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
Patients where the Cor TRICUSPID ECM Valve will be the physiological right-sided atrioventricular (AV) valve
Disqualifiers
Tricuspid annulus too small (< 10mm) to accommodate the Cor TRICUSPID ECM Valve
Left ventricular ejection fraction (LVEF) < 25%
Mean pulmonary pressure ≥ 50mmHg 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
- Tricuspid valve replacement with the Cor TRICUSPID ECM Valve
Treatment groups
92 Participants
are divided into 4 treatment groupsSponsors and collaborators
Corvivo Cardiovascular, Inc.
Lead sponsor
Yale University
Collaborator
Source ClinicalTrials.gov