SANTA MONICA – Continuing its tradition of championing minimally invasive, leading-edge techniques, Providence Saint John’s Health Center was one of two institutions worldwide to enroll patients in a new clinical trial for a novel device designed to reduce the risk of stroke in patients with atrial fibrillation (A-fib), an irregular heartbeat that can cause blood clots in the heart.
This week at Providence Saint John’s, Shephal Doshi, M.D., FACC, implanted Conformal Medical, Inc.’s CLAAS® device, making him one of the first cardiologists in the world to enroll patients in the new international clinical trial. The novel CLAAS technology uses a unique foam-based design to conform to each patient’s left atrial appendage – the area of the heart where blood clots can form during A-fib. The device then closes the area to reduce the risk of blood clots and to prevent the need for long-term blood thinning medications, which carry a risk of bleeding.
Wednesday’s landmark procedure comes a little more than seven years after Dr. Doshi became the first in the U.S. to complete a commercial implant of the WATCHMAN— the first approved device to protect patients from stroke related to A-fib.
“We are proud to continue our pioneering work in this field and to be among the first to enroll patients in this worldwide study of the CLAAS device, which can provide an alternative to the current commercial devices and the potential benefits of lowering the risk of blood clots and strokes, and better sealing and closing the appendage of the heart,” said Dr. Doshi, executive director of the Heart and Vascular Institute at Providence Saint John’s and director of cardiac electrophysiology at the Pacific Heart Institute. He is a co-principal investigator of the clinical trial.
In addition to being the first in the world to enroll patients in the clinical trial, Providence Saint John’s is the only hospital in the Los Angeles Area and one of a handful of centers worldwide to take part in the study. Another patient also was treated today by co-principal investigator Dr. William Gray at the Lankenau Heart Institute at Main Line Health in Wynnewood, Pa.
Like other minimally invasive treatments and devices in the industry, such as the WATCHMAN, the CLAAS System uses a small incision in the groin to insert the tiny device into the heart’s left atrial appendage — a small ear-shaped sac in the muscle wall of the top left chamber that can form blood clots during A-fib. Once in place, the CLAAS device seals off the appendage to prevent the formation of blood clots that can lead to stroke.
However, unlike other devices, this novel technology uses foam instead of metal as the basis of its design. The change allows the device to mold and fit to each patient’s anatomy, which can reduce the potential for complications and could simplify the procedure.
“I’m excited about the additional safety benefits this device’s design may offer patients,” Dr. Doshi said. “The foam from the device is able to take the shape of the appendage and conform to accommodate different anatomies, which can more effectively prevent blood clots and further reduce a patient’s need for blood thinners.”
Conformal Medical expects to enroll approximately 1,600 patients from the United States, Canada and Japan in its Pivotal Clinical Trial. Throughout the multi-center, randomized study, participants will evaluate the safety and efficacy of the CLAAS System compared to other commercial devices to possibly support a pre-market approval from the U.S. Food and Drug Administration (FDA).