Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • CorMatrix Cor TRICUSPID ECM Valve

    Device

    CorMatrix Cor TRICUSPID ECM Valve to replace a diseased tricuspid valve, including tricuspid valve disease secondary to congenital heart disease.

Treatment groups

78 Participants
are divided into 1 treatment group
Group A: CorMatrix Cor TRICUSPID ECM ValveExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Procedural Success

Device Success and No TV device- or TV procedure-related SAE's

Time frame
30 days postop

Secondary outcomes

1

Device Success

Patient alive with original intended CorMatrix ECM TV in place, No additional surgical or interventional procedures related to the TV, and Intended performance of the TV

Time frame
30 day and all follow up time points
2

Technical Success

Exit OR Alive, Successful implant of the single intended CorMatrix ECM TV, No need for additional emergency surgery or re-intervention related to the TV device, Final post-op TTE shows TR \< moderate

Time frame
within 24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Corvivo Cardiovascular, Inc.

Lead sponsor

Source ClinicalTrials.gov
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