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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Tricuspid valve replacement with the Cor TRICUSPID ECM Valve
DeviceTricuspid valve replacement with the Cor TRICUSPID ECM Valve for the surgical management of tricuspid valve disease or dysfunction.
Treatment groups
92 Participants
are divided into 4 treatment groupsGroup A: Group A: Adults treated with SIS 1.0 Cor TRICUSPID ECM ValveOther 1 intervention
Group B: Group B: Pediatrics treated with SIS 1.0 Cor TRICUSPID ECM ValveOther 1 intervention
Group C: Group C: Adults treated with SIS 2.0 Cor TRICUSPID ECM ValveOther 1 intervention
Group D: Group D: Pediatrics treated with SIS 2.0 Cor TRICUSPID ECM ValveOther 1 intervention
Trial outcomes
Primary outcomes
1
Safety Outcome - Procedural Success
Device Success and no tricuspid valve device-related Serious Adverse Events (SAEs)
Time frame
30 days2
Effectiveness Outcome - Individual Patient Success
* Device success and * no Cor TRICUSPID ECM Valve-related re-hospitalizations or re-interventions of the Cor TRICUSPID ECM Valve (clinically significant: new endocarditis of the tricuspid valve \[TV\], recurrence of tricuspid regurgitation \[TR\] \> moderate, or right sided heart failure \[HF\]) unless endocarditis is secondary to recurrent drug abuse. * Improvement vs. baseline in symptoms (improvement in New York Heart Association \[NYHA\] \[adult subjects\] and clinical improvement \[pediatric subjects\] Class \>/= 1 grade)
Time frame
6 months3
Effectiveness Outcome - Individual Patient Success
* Device success and * no Cor TRICUSPID ECM Valve-related re-hospitalizations or re-interventions of the Cor TRICUSPID ECM Valve (clinically significant: new endocarditis of the tricuspid valve \[TV\], recurrence of tricuspid regurgitation \[TR\] \> moderate, or right sided heart failure \[HF\]) unless endocarditis is secondary to recurrent drug abuse. * Improvement vs. baseline in symptoms (improvement in New York Heart Association \[NYHA\] \[adult subjects\] and clinical improvement \[pediatric subjects\] Class \>/= 1 grade)
Time frame
12 monthsOther outcomes
1
Technical Success
* Alive at exit from OR with: * Successful implant of the single intended Cor TRICUSPID ECM Valve * No need for additional emergency surgery or re-intervention related to the Cor TRICUSPID ECM Valve device * Final post-op transthoracic echocardiogram (TTE) (at 1 week or prior to discharge) shows tricuspid valve regurgitation \</= moderate
Time frame
One week or prior to hospital discharge2
Device Success
No device-related mortality, with * Original intended Cor TRICUSPID ECM Valve in place, and * No additional surgical or interventional procedures related to the Cor TRICUSPID ECM Valve, and * Intended performance of the Cor TRICUSPID ECM Valve: 1. No clinically significant dysfunction of the tricuspid valve: defined as TR \> moderate (except patients with recurrent drug abuse) • This includes clinically significant: detachment of the annular or papillary muscle fixation, hemolysis, para-device complications (effects on coronary circulation, paravalvular leaks) or new endocarditis, and 2. Expected hemodynamic performance: * Valve mean gradient \< 6mmHg \[with heart rate ≤70 bpm for age ≥ 14; no HR restrictions for those \<14 years\] and * Valve regurgitation ≤ moderate
Time frame
30 days3
Device Success
No device-related mortality, with * Original intended Cor TRICUSPID ECM Valve in place, and * No additional surgical or interventional procedures related to the Cor TRICUSPID ECM Valve, and * Intended performance of the Cor TRICUSPID ECM Valve: 1. No clinically significant dysfunction of the tricuspid valve: defined as TR \> moderate (except patients with recurrent drug abuse) • This includes clinically significant: detachment of the annular or papillary muscle fixation, hemolysis, para-device complications (effects on coronary circulation, paravalvular leaks) or new endocarditis, and 2. Expected hemodynamic performance: * Valve mean gradient \< 6mmHg \[with heart rate ≤70 bpm for age ≥ 14; no HR restrictions for those \<14 years\] and * Valve regurgitation ≤ moderate
Time frame
6 months4
Device Success
No device-related mortality, with * Original intended Cor TRICUSPID ECM Valve in place, and * No additional surgical or interventional procedures related to the Cor TRICUSPID ECM Valve, and * Intended performance of the Cor TRICUSPID ECM Valve: 1. No clinically significant dysfunction of the tricuspid valve: defined as TR \> moderate (except patients with recurrent drug abuse) • This includes clinically significant: detachment of the annular or papillary muscle fixation, hemolysis, para-device complications (effects on coronary circulation, paravalvular leaks) or new endocarditis, and 2. Expected hemodynamic performance: * Valve mean gradient \< 6mmHg \[with heart rate ≤70 bpm for age ≥ 14; no HR restrictions for those \<14 years\] and * Valve regurgitation ≤ moderate
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Corvivo Cardiovascular, Inc.
Lead sponsor
Yale University
Collaborator
Source ClinicalTrials.gov