UC Irvine Health System
12/05/2023 | Press release | Distributed by Public on 12/05/2023 22:00
UCI Health launches clinical trial of minimally invasive treatment to repair tricuspid regurgitation
UCI Health launches clinical trial of minimally invasive treatment to repair tricuspid regurgitation
The treatment may offer a way to repair the valve without the need for open-heart surgery
December 05, 2023
Illustration of a heart with tricuspid regurgitation (top) and one that
has been repaired with the PASCAL system. Credit:
Edwards Lifesciences.
Orange, Calif. - The multidisciplinary UCI Health Cardiology Services team at UCI Medical Center is launching a pivotal trial to evaluate an innovative, minimally invasive treatment for patients with tricuspid regurgitation.
In patients with tricuspid regurgitation (TR), the tricuspid valve does not close completely, causing blood to flow backward through the heart valve. TR can cause shortness of breath, fatigue and swelling in the extremities. If left untreated, TR can lead to heart failure.
Antonio Halais Frangieh, MD, a UCI Health cardiologist and medical director of the UCI Health Structural Heart Program, is the trial's principal investigator.
The CLASPTM II TR trial is evaluating the safety and effectiveness of the Edwards PASCAL repair system in patients with symptomatic severe TR. The PASCAL repair system is designed to repair the "flaps" or leaflets of the tricuspid valve, using a catheter inserted via a major vein of the leg.
Many patients with TR are not eligible for open-heart surgery because of their age or other pre-existing medical conditions. Open-heart surgery is also associated with longer recovery time than less invasive approaches. As a result, there is an unmet need for alternative, minimally invasive therapies such as the PASCAL repair system.
UCI Health chosen for expertise
Patients participating in this randomized controlled trial will be treated with either the PASCAL repair system in conjunction with optimal medical therapy (OMT) or OMT alone.
Patients will go through a rigorous screening process and if enrolled will be evaluated at discharge, 30 days, three months, six months and annually through five years after the procedure.
"Our heart team was chosen for this trial because of its expertise with minimally invasive transcatheter valve repair," said Frangieh. "With this trial, our goal is to provide a device that may allow more patients the opportunity to be treated for TR via a less invasive option than open-heart surgery."
There are risks associated with taking part in a clinical trial. There may be unpleasant, serious or even life-threatening effects of experimental treatment. Ask your research coordinator or doctor to learn more about the potential risk specific to this trial before signing the trial's informed consent.
About Dr. Antonio Halais Frangieh
Frangieh is a UCI Health cardiologist who specializes in interventional cardiology and structural heart disease.
He is an internationally regarded expert in structural heart disease therapies, including transcatheter aortic valve replacement (TAVR), mitral and tricuspid valve repair and replacement, left atrial appendage closure, paravalvular leak closure, closure of atrial septal defects and patent foramen ovales, and complex percutaneous coronary intervention (PCI).
He is the author of more than 50 peer-reviewed articles and editorials published in prestigious medical journals, particularly on transcatheter valve therapy and percutaneous coronary interventions. Frangieh is an associate editor for the journal BMC Cardiovascular Disorders and Cardiology Journal. He is also an international consultant and clinical proctor for transcatheter aortic, mitral and tricuspid valve therapies. Working with Irvine-based Edwards Lifesciences, he recently served as a physician advisor and proctor for multiple first-in-human and early feasibility trials of new structural heart treatment systems.
About UCI Health
UCI Health is the clinical enterprise of the University of California, Irvine, and the only academic health system in Orange County. Patients can access UCI Health at primary and specialty care offices across Orange County and at its main campus, UCI Medical Center in Orange, Calif. The 459-bed, acute care hospital, listed among America's Best Hospitals by U.S. News & World Report for 23 consecutive years, provides tertiary and quaternary care, ambulatory and specialty medical clinics, behavioral health and rehabilitation services. UCI Medical Center is home to Orange County's only National Cancer Institute-designated comprehensive cancer center, high-risk perinatal/neonatal program and American College of Surgeons-verified Level I adult and Level II pediatric trauma center and regional burn center. UCI Health serves a region of nearly 4 million people in Orange County, western Riverside County and southeast Los Angeles County. Follow us on Facebook, Instagram, LinkedIn and Twitter.