Aurora St. Luke’s Medical Center in Milwaukee is the first site in Wisconsin to join a clinical trial studying a new potential alternative treatment device for people with mitral regurgitation.
The pivotal, randomized clinical trial will evaluate the safety and effectiveness of a transcatheter mitral valve repair (TMVr) procedure using the Edwards PASCAL Transcatheter Valve Repair System compared to a competing device, which is already approved by the U.S. Food and Drug Administration. TMVr is designed to treat people with degenerative mitral regurgitation (DMR) who are determined to be at too high of risk for open heart surgery or people with functional mitral regurgitation (FMR) who currently receive the standard medical treatment.
“There are different types of mitral regurgitation, but, in general, it occurs when the heart’s mitral valve does not close properly, allowing blood to flow back into the lungs,” said interventional cardiologist Suhail Allaqaband, MD, Advocate Aurora Research Institute’s principal investigator for the study. “This forces the heart to have to work harder and, left unchecked, can lead to heart failure.”
DMR, which is sometimes called primary mitral regurgitation, occurs because of a problem or injury to the valve or the valve’s leaflets. FMR, which is sometimes called secondary mitral regurgitation, occurs when the valve is working correctly but problems with the heart muscles prevent the valve leaflets from fully closing.
TMVr is a minimally invasive procedure in which a team of cardiologists and cardiac surgeons insert the device via a small tube called a catheter through a small incision in the femoral vein in the leg. The doctors then carefully thread the catheter, guided by imaging technology, through the body’s chain of blood vessels until it reaches the placement point in the heart, at which point the device is implanted and the catheter is removed.
“The investigational PASCAL device implant is designed to clip to the mitral valve leaflets, pinching them together in the center of the mitral valve orifice,” Dr. Allaqaband said. “This creates two smaller openings that can properly open and close as the heart pumps blood.”
Despite the significant health risks associated with mitral regurgitation, prior studies show that as many as 70% of patients with the disease do not receive surgical mitral valve repair or replacement because surgery is considered too risky.
“The currently approved mitral valve repair system is an option for some of these patients, but, for others, the anatomy of their faulty mitral valve makes them ineligible to receive that particular device,” said Laura Wrona, MSN, director of cardiovascular clinical trials research. “As a leader in transcatheter valve replacement and repair for nearly a decade, Advocate Aurora Health is proud to help search for alternative minimally invasive options for our patients.”
Researchers across the country plan to enroll up to 1,347 participants in the clinical trial, “Edwards PASCAL CLASP IID/IIF pivotal clinical trial (CLASP IID/IIF),” which is sponsored by Edwards Lifesciences, manufacturer of the study device.
To learn more about Advocate Aurora’s research, visit aurora.org/research.