Cor TRICUSPID ECM Valve Replacement for Tricuspid Valve Disease
This study is testing a new heart valve called the Cor TRICUSPID ECM Valve. This valve is designed to replace a faulty tricuspid valve (one of the heart's four valves) in both adults and children. The main goals are to see if the valve can be safely and successfully put in place, and if it effectively treats tricuspid valve disease for up to 12 months. You could be eligible if you have a tricuspid valve that isn't working right and needs surgery, even if you're having other heart procedures at the same time. The study is currently enrolling 92 participants.
- Study design
- This is an interventional study planning to enroll 92 participants. It is designed to evaluate the safety and effectiveness of the Cor TRICUSPID ECM Valve.
- What's involved
- You would have a preoperative evaluation, tricuspid valve replacement surgery, and then follow-up evaluations at hospital discharge, 30 days, 6 months, and 12 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed annually after the first year, through 5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study
At a glance
Conditions
NCT05742906
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Columbia University Irving Medical Center/New York Presbyterian
New York, New Yorkstudy coordinator listed
Recruiting
St Francis Hospital
Indianapolis, Indianastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Robert Matheny, MD · STUDY_DIRECTOR · Corvivo Cardiovascular, Inc.
- Brad Solberg, MBA · STUDY_DIRECTOR · Veranex
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Safety Outcome - Procedural Success30 days
Device Success and no tricuspid valve device-related Serious Adverse Events (SAEs)
- Effectiveness Outcome - Individual Patient Success6 months
* 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)
- Effectiveness Outcome - Individual Patient Success12 months
* 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)