CorMatrix® Cor™ TRICUSPID ECM® Valve Replacement Study
Corvivo Cardiovascular, Inc.
Summary
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
Description
CorMatrix Cardiovascular, Inc. has developed a device for heart valve replacement, the Cor TRICUSPID ECM Valve for adults and the Cor PEDIATRIC Tricuspid ECM Valve for pediatrics (collectively these devices will be referred to as the Cor TRICUSPID ECM Valve(s)), which can be implanted to replace dysfunctional tricuspid heart valves. The objective of this Pivotal Study is to collect safety and effectiveness data on surgical tricuspid valve replacement procedures using the Cor TRICUSPID ECM valve to support a Humanitarian Device Exemption (HDE) marketing application. Because the majority of tri…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patient with a regurgitant or absent tricuspid valve requiring surgical treatment including those patients having concomitant cardiac procedures 2. 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 3. Patient/patient's authorized legal guardian is geographically stable (or willing to return for required study follow-up) and understands and is willing to fu…
Interventions
- DeviceTricuspid valve replacement with the Cor TRICUSPID ECM Valve
Tricuspid valve replacement with the Cor TRICUSPID ECM Valve for the surgical management of tricuspid valve disease or dysfunction.
Locations (2)
- St Francis HospitalIndianapolis, Indiana
- Columbia University Irving Medical Center/New York PresbyterianNew York, New York