PRESS RELEASE: The Cardiac & Vascular Institute Research Foundation First in Florida in Pivotal Clinical Trial


July 20, 2020

First In Florida – The Florida Structural Heart Disease Center Together With The Cardiac & Vascular Institute Research Foundation Implant Pascal Transcatheter Mitral Valve Repair Device In The Pascal Clasp Iid Pivotal Trial

 

The Florida Structural Heart Disease Center at North Florida Regional Medical Center together with The Cardiac & Vascular Institute Research Foundation today announced they are first in Florida to successfully implant the Edwards Lifesciences PASCAL CLASP IID/IIF device as a part of the Edwards Lifesciences PASCAL CLASP IID/IIF Pivotal Clinical Trial. The PASCAL CLASP IID trial will evaluate the Edwards PASCAL transcatheter device for the management of patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Structural Heart Team, and the PASCAL CLASP IIF trial will evaluate the Edwards PASCAL transcatheter device for the management of patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT). The first case at North Florida Regional Medical Center was a part of the PASCAL CLASP IID cohort.

Read the entire news release here: PASCAL IRB Approved Release