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 site activated in the state of Florida in the Edwards Lifesciences PASCAL CLASP II TR Pivotal Clinical Trial. This clinical trial will evaluate the PASCAL transcatheter device for the management of patients with tricuspid regurgitation who have been determined to be at intermediate or greater risk for tricuspid valve surgery by the Structural Heart Team.

Tricuspid valve regurgitation is a condition in which the valve between the two right chambers of the heart does not close completely, causing blood to leak back into the right atrium of the heart. This increases the workload on the heart and if left untreated, can increase the risk of right-sided heart failure. While there are several treatment options including open heart surgery for patients with tricuspid valve regurgitation, not everyone is a candidate for surgery. Transcatheter Tricuspid Valve Repair (TTVR) delivers a minimally invasive, catheter-based treatment option for those with tricuspid 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 Tricuspid Valve Repair technology to North Central Florida.

“Tricuspid valve disease in isolation has long plagued both patients and treating physicians because of the devastating consequences and lack of good therapeutic options,” says Charles Klodell, M.D., co-principle investigator in the clinical trial. “This trial and device will offer new hope to patients that previously may have suffered with lack of options.  We are fortunate to have a robust structural heart team and program that facilitated bringing this trial to our region and providing this option to the patients of Florida.”

“For a long time, tricuspid regurgitation (TR) was not fully appreciated and was never a therapeutic priority. The tricuspid valve has been known as the forgotten valve. The edge-to-edge repair of the tricuspid valve with this device is feasible and data is very promising,” says Ilie Barb, M.D., co-principle investigator in the clinical trial. “Following TAVR and TMVR, both minimally invasive options for aortic and mitral valve disease, we are now extremely honored to be able to offer our patients this cutting edge therapy for tricuspid valve disease.”