Condition: Tricuspid Valve Disease · Tricuspid Valve Insufficiency · Sponsor: Corvivo Cardiovascular, Inc.
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
This description comes directly from the study's public registry record.
Robert G Matheny, MD · 404-276-7777 · Rmatheny@Cormatrix.com
Brad Solberg, MBA · 4084644001 · brad@experiengroup.com
Always discuss trial participation with your own doctor first.
| St Francis Hospital | Indianapolis, Indiana, United States | Recruiting |
| Columbia University Irving Medical Center/New York Presbyterian | New York, New York, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05742906