August 25, 2020
Gainesville, FL - The Florida Structural Heart Disease Center at North Florida Regional Medical Center (NFRMC) together with The Florida Heart & Lung Institute (FHLI) and The Cardiac & Vascular Institute Research Foundation (TCAVIRF), have announced that they are the first in the state of Florida to implant the Edwards Lifesciences PASCAL CLASP IID/IIF device as a part of the Edwards Lifesciences PASCAL CLASP IID/IIF Pivotal Clinical Trial. This clinical trial will evaluate the Edwards PASCAL transcatheter valve repair system for the management of patients with mitral regurgitation who have been determined to be at prohibitive risk for mitral valve surgery by the Structural Heart Team; there is a separate cohort class (IIF) studying patients with functional mitral regurgitation (FMR).
Mitral valve regurgitation is a condition in which the mitral valve does not close completely, causing blood to leak back into the left atrium of the heart. This increases the workload on the heart and if left untreated, can increase the risk of heart failure. Open heart surgery is an effective treatment for patients with mitral valve regurgitation, however, not everyone is a candidate for surgery. Transcatheter Mitral Valve Repair (TMVR) provides a minimally invasive, catheter-based procedure treatment option for those with mitral problems unable to undergo surgery.
The Structural Heart Program, co-led by Florida Heart & Lung Institute's Cardiothoracic Surgeon Charles Klodell, M.D. and The Cardiac & Vascular Institute's Interventional Cardiologist Ilie Barb, M.D., has been instrumental in bringing this ground breaking Transcatheter Mitral Valve Repair technology to North Central Florida. "We are happy to offer the new PASCAL transcatheter mitral valve repair system as it is a promising tool that increases our arsenal to treat the mitral valve. On June 23rd , we treated our first patient in the trial and they were overwhelmingly excited to be the first patient enrolled and to receive the device in Florida," says Charles Klodell, M.D., co-principle investigator in the clinical trial. "We are proud of the top tier Structural Heart Program that we have collaboratively built here in Gainesville which positioned us to become a site for PASCAL CLASP IID/IIF clinical trial and the first site to implant the PASCAL CLASP IID/IIF device in the state of Florida," says Ilie Barb, M.D., co-principle investigator in the clinical trial.
This is just one of the many clinical trials that are offered to patients at the Florida Structural Heart Disease Center together with The Cardiac & Vascular Institute Research Foundation at North Florida Regional Medical Center. There are multiple clinical trials offered for structural heart disease in addition to various other cardiac and vascular clinical trials. To learn more, patients can contact The Cardiac & Vascular Institute Research Foundation, Florida Heart & Lung Institute and North Florida Regional Medical Center.