Adam Greenbaum, MD, co-director, Structural Heart and Valve Center, Emory University Hospital Midtown, Atlanta, explains details from the late-breaking CLASP TR trial at the American College of Cardiology (ACC) 2022 meeting. The pilot study evaluated the safety and performance of the Edwards Lifesciences Pascal transcatheter valve repair clip system in symptomatic severe tricuspid regurgitation (TR).
Patients with tricuspid regurgitation, a common and debilitating form of valvular heart disease, who received a Pascal investigational device that allows for a minimally invasive edge-to-edge repair (TEER) of the valve leaflets so they can seal better to prevent blood back flow, experienced significant improvements in blood flow and quality of life at one year. Outcomes were better than the current standard of care, optimal medical therapy (OMT), which Greenbaum said is not a great option because the patients need more support than what medication alone can offer.
“At one year of follow-up, the repair procedure appears to be safe and significantly reduced the severity of patients’ tricuspid regurgitation and improved their ability to function in daily life, maintaining gains that we previously saw at 30 days of follow-up,” Greenbaum, who is also an associate professor of medicine at Emory University School of Medicine, explained.
Tricuspid regurgitation affects an estimated 1.6 million people in the U.S. and increases as each generation ages. The study offers further validation for TEER, Greenbaum said. He said minimally invasive options are needed to treat tricuspid regurgitation, Greenbaum said, as most patients with the condition are older and may have other health problems that make them poor candidates for open-heart surgery.
The CLASP-TR study is a feasibility study of an investigational transcatheter repair system for tricuspid regurgitation. Greenbaum said they are already prepping for the CLASP II TR study, which will widen enrollment to 825 patients.
Related ACC 2022 News:
Links to all the ACC 2022 late-breaking clinical trials
Key Interventional Cardiology Takeaways at ACC 2022
Find more ACC news, video and photos
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: dfornell@innovatehealthcare.com