CorMatrix Cor TRICUSPID ECM Valve Replacement Study
Corvivo Cardiovascular, Inc.
Summary
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.
Description
CorMatrix Cardiovascular, Inc. has developed a device for heart valve replacement, the CorMatrix® Cor ECM® Tricuspid Valve, which can be implanted to replace dysfunctional tricuspid heart valves. This Pivotal Study is being performed to verify the ability to successfully implant the Tricuspid Valve, the clinical safety of the device, and whether the device performs its intended use. The study is a multi-center, prospective, single-arm, Pivotal Study of subjects receiving the Cor TRICUSPID ECM Valve or Cor PEDIATRIC Tricuspid ECM Valve. The study will be conducted at up to 15 sites. Up to 60 s…
Eligibility
- Age range
- 1–85 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Patient with a regurgitant or absent tricuspid valve requiring surgical treatment including those patients having concomitant cardiac procedures 2. Male or female 3. 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 4. Patient/patient's authorized legal guardian is geographically stable (or willing to return for required study follow-up) and understands an…
Interventions
- DeviceCorMatrix Cor TRICUSPID ECM Valve
CorMatrix Cor TRICUSPID ECM Valve to replace a diseased tricuspid valve, including tricuspid valve disease secondary to congenital heart disease.
Locations (4)
- Springhill Memorial HospitalMobile, Alabama
- St Francis HospitalIndianapolis, Indiana
- MedstarBaltimore, Maryland
- Cincinnati Children's HospitalCincinnati, Ohio