EARLY FEASIBILITY STUDY OF THE CARDIOVALVE SYSTEM FOR TRICUSPID REGURGITATION (CARDIOVALVE)
Sponsor: |
Boston Biomedical Associates |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAS9217 |
U.S. Govt. ID: |
NCT04100720 |
Contact: |
Kate Dalton: 347-514-3366 / keb2114@cumc.columbia.edu |
This is a prospective, multi-center open label first in human clinical study aimed at demonstrating safety and technical performance of the Cardiovalve device to minimize tricuspid regurgitation. Tricuspid regurgitation is a disorder in which the valve does not close tight enough. This problem causes blood to flow backward into the right upper heart chamber (atrium) when the right lower heart chamber (ventricle) contracts. The purpose is to evaluate the safety and technical performance of the Cardiovalve System to successfully treat patients with severe tricuspid regurgitation. The tricuspid valve replacement device will treat patients with severe tricuspid regurgitation that would otherwise be referred for surgical tricuspid valve replacement. The product is designed to enter by way of the femoral artery, which is the large artery in the groan. The aim is to provide a functioning valve that is consistent with current surgical technology that can be placed in a minimally invasive manner for patients that are not currently ideal candidates for surgery.
This study is closed
Investigator
Susheel Kodali, MD
Are you between 18 and 84 years of age? |
Yes |
No |