Henry Ford Health to Lead First-of-its-Kind National Trial for Innovative Heart Device
Clinical trial will enroll more than 3,000 patients across 75 participating hospitals in U.S.
DETROIT, Dec. 6, 2022 /PRNewswire/ -- Henry Ford Health will be spearheading a multi-center, first-of-its-kind national clinical trial dubbed the "CORRAL-AF IDE" study for an innovative left atrial appendage occlusion device known as the LAmbre™ Plus Left Atrial Appendage Closure System.
Left atrial appendage occlusion (LAAO), also referred to as left atrial appendage closure, is a treatment strategy to reduce the risk of blood clots from the left atrial appendage entering the bloodstream and causing a stroke in patients with non-valvular atrial fibrillation.
LAAO devices are implanted in the heart and are intended to reduce the risk of thromboembolism from the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation. The device mechanically occludes the LAA to prevent LAA thrombus, a condition commonly associated with atrial fibrillation or AFib, from entering the systemic circulation, which carries oxygenated blood from the left ventricle through the arteries to the capillaries in the tissues of the body.
Brian O'Neill, M.D., a Henry Ford Health specialist in interventional cardiology, will be the lead investigator for the trial that will be facilitated at 75 hospitals across the United States.
Dr. O'Neill announced the FDA-approved clinical trial at the annual CSI-LAA Focus Conference held in Frankfurt, Germany last month to interventional cardiologists and electrophysiologists attending from around the world.
"Left atrial appendage occlusion has emerged as an important therapy to help reduce the risk of stroke in those patients with non-valvular atrial fibrillation," said Dr. O'Neill. "We hope this trial will offer yet another option to those patients who may be searching for an alternative to anti-coagulation."
The trial received the necessary approval from the Food & Drug Administration in March and from the Centers for Medicare & Medicaid Services in August. The approvals open the way for patients to enroll in the clinical trial and be fully covered by U.S. medical insurance providers.
This prospective, randomized controlled, multicenter clinical trial will provide important clinical data that will help investigators evaluate the safety and effectiveness of implanting the innovative device in Non-Valvular Atrial Fibrillation patients with large and/or irregularly shaped, multi-lobed appendages, as compared to oral anticoagulants used to prevent blood clots.
The trial plans to enroll more than 3,000 people across 75 participating hospitals with more than 1,500 implantations of the LAmbre™ Plus LAA device.
"This is a very important clinical trial with the potential to expand patients' options to a device therapy for irregular or multi-lobed complex LAA anatomies," said Dee Dee Wang, M.D., a Henry Ford specialist in structural heart imaging and a co-investigator for the trial.
The study obtained CMS reimbursement, which ensures that all patients participating in the clinical trial will be fully covered by medical insurance in the U.S.
If the CORRAL-AF IDE trial results reach the established clinical and safety evidence objectives, the trial results would be presented to the FDA for approval to make the new device available to the public.
To learn more about cardiology care and innovations at the Henry Ford Heart & Vascular Institute, visit henryford.com/services/cardiology.
ABOUT HENRY FORD HEALTH
Serving communities across Michigan and beyond, Henry Ford Health is committed to partnering with patients and members along their entire health journey. Henry Ford Health provides a full continuum of services – from primary and preventative care, to complex and specialty care, health insurance, a full suite of home health offerings, virtual care, pharmacy, eye care and other healthcare retail.
It is one of the nation's leading academic medical centers, recognized for clinical excellence in cancer care, cardiology and cardiovascular surgery, neurology and neurosurgery, orthopedics and sports medicine, and multi-organ transplants. Consistently ranked among the top five NIH-funded institutions in Michigan, Henry Ford Health engages in more than 2,000 research projects annually. Equally committed to educating the next generation of health professionals, Henry Ford Health trains more than 4,000 medical students, residents and fellows every year across 50+ accredited programs.
With more than 33,000 valued team members, Henry Ford Health is also among Michigan's largest and most diverse employers, including nearly 6,000 physicians and researchers from the Henry Ford Medical Group, Henry Ford Physician Network and Jackson Health Network.
The health system is led by President and CEO Robert G. Riney and serves a growing number of customers across 250+ locations throughout Michigan including five acute care hospitals, two destination facilities for complex cancer and orthopedics and sports medicine care, three behavioral health facilities, primary care and urgent care centers.
SOURCE Henry Ford Health
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