Tampa General Hospital (TGH) and USF Health have achieved a milestone by performing Florida’s first TricValve procedure under the FDA Early Feasibility Study.
The minimally invasive treatment targets severe tricuspid regurgitation, offering hope to cardiac patients with this life-threatening condition.
The procedure was conducted in April 2025 as part of the TRICAV 1 clinical study.
Interventional structural cardiologists at TGH and USF Health, including Dr. Hiram Bezerra and Dr. Fadi Matar, led the procedure.
The TricValve System was implanted using a transcatheter approach, reducing the risks associated with open surgery and improving symptoms by addressing backward blood flow.
Bezerra said: “Cardiac disease remains the leading cause of death in America, with severe tricuspid regurgitation representing a significant, unmet medical need.
“Tampa General is committed to constant innovation and assessment of therapeutic options that may provide a benefit over current standard of care treatments for our patients.
“Our role as a leading cardiac institute and academic medical centre positions us at the forefront of research for groundbreaking interventions.
“We are excited to be the first in Florida to help advance this technology towards FDA review and, if approved, broader patient use.”
The TRICAV 1 study, sponsored by P&F Products and Features, aims to evaluate the safety and effectiveness of the TricValve System.
The multicenter trial aims to improve outcomes for patients with severe tricuspid regurgitation who are unsuitable for surgery.
USF Health’s Department of Internal Medicine leads the TRICAV 1 trial, showcasing its commitment to innovative research in cardiovascular sciences.
Its robust infrastructure supports a diverse portfolio of studies, enhancing clinical care and medical knowledge in areas such as heart failure and interventional cardiology.
Matar said: “Tampa General’s Heart and Vascular Institute provides world-class cardiac care, from simple procedures to groundbreaking interventions, to the Tampa community and beyond.
“We are grateful for the support of donors who allow us to pursue this work, and proud of our talented team members and world-class facilities, who work to bring these concepts from the lab to the operating room.”
