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The clinical trial will enroll more than 3,000 patients at 75 participating US hospitals.
DETROIT, December 6, 2022 /PRNewswire/ — Henry Ford Health will lead a multi-center, first-of-its-kind national clinical trial called 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 stroke in patients with non -valvular atrial fibrillation.
Henry Ford Health interventional cardiologist Brian O’Neill, MD, is leading a first-of-its kind clinical trial that will enroll more than 3,000 patients at 75 participating US hospitals to study the an innovative left atrial appendage occlusion device. The trial will test the safety and effectiveness of the new heart device.
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 closes 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 body tissues.
Brian O’NeillMD, a Henry Ford Health specialist in interventional cardiology, will be the lead investigator for the trial that will be conducted at 75 hospitals nationwide The united state.
Dr. announced O’Neill’s FDA-approved clinical trial at the annual CSI-LAA Focus Conference held at 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 patients with non-valvular atrial fibrillation,” said Dr. O’Neill. “We hope this trial will offer another option to patients who may be looking for an alternative to anti-coagulation.”
The trial received the necessary approval from the Food and Drug Administration in March and from the Centers for Medicare & Medicaid Services in August. The approvals pave the way for patients to enroll in clinical trials and be fully covered by US medical insurance providers.
This prospective, randomized controlled, multicenter clinical trial will provide important clinical data that will help investigators evaluate the safety and efficacy of implanting the innovative device in Non-Valvular Atrial Fibrillation patients with large and /or irregularly shaped, multi-lobed appendages, compared to oral anticoagulants used to prevent blood clots.
The trial plans to enroll more than 3,000 people at 75 participating hospitals with more than 1,500 implantations of the LAmbre™ Plus LAA device.
“This is a very important clinical trial that has the potential to expand patients’ options in a device therapy for irregular or multi-lobed complex LAA anatomies,” said Dee Dee WangMD, 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 US medical insurance
If the CORRAL-AF IDE trial results meet the established clinical and safety evidence objectives, the trial results will 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 as a whole Michigan and more, Henry Ford Health is committed to partnering with patients and members throughout their health journey. Henry Ford Health provides a full continuum of services – from primary and preventive care, to complex and specialty care, health insurance, a full range of home health offerings, virtual care, pharmacy, health care eye and other retail health care.
It is one of the country’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. Dedicated to educating the next generation of health professionals, Henry Ford Health trains more than 4,000 medical students, residents and fellows each year in 50+ accredited programs.
With more than 33,000 valued team members, Henry Ford Health is also included in Michigan largest and most diverse employer, including nearly 6,000 physicians and researchers from Henry Ford Medical Group, Henry Ford Physician Network and Jackson Health Network.
The health system is led by the President and CEO Robert G. Riney and serves a growing number of customers at 250+ locations in total 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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