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EARLY FEASIBILITY STUDY OF THE CARDIOVALVE SYSTEM FOR TRICUSPID REGURGITATION (CARDIOVALVE)
Cardiovalve System for Tricuspid Regurgitation
Sponsor:Boston Biomedical Associates
Enrolling:Male and Female Patients
Age Range:Between 18 and 84 years old
IRB Number:AAAS9217
U.S. Government ID:NCT04100720
Contact: Kate Dalton: 347-514-3366 / keb2114@cumc.columbia.edu
Additional Study Information:

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.

Do You Qualify?
Are you between 18 and 84 years of age?YesNo
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Investigator
Susheel Kodali, MD
You may be eligible for this study

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Who Can I Contact?
For more information, please contact:
Kate Dalton
Email: keb2114@cumc.columbia.edu
Phone: 347-514-3366