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Scripps Clinic Cardiologists Enroll First San Diego County Patient in Trial of Experimental Heart Failure Device Minimally invasive procedure part of interatrial shunt device clinical trial LA JOLLA, Calif. – Scripps Clinic cardiologists this week enrolled the first San Diego County patient in an international clinical trial of an experimental interatrial shunt device designed to relieve symptoms from heart failure. The female patient was enrolled in the randomized study by interventional cardiologist Matthew Price, M.D., in the cardiac catheterization laboratory at the John R. Anderson V Medical Pavilion on the campus of Scripps Memorial Hospital La Jolla. The interatrial shunt device is implanted within the atrial septum, the wall of tissue separating the heart’s upper chambers – the right and left atria. In heart failure, blood pressure builds up in the left atrium, which leads to breathlessness and fatigue, particularly during exercise, as well as water retention. The device, a small scaffold of metal wire, holds open a small hole within this wall. As a result, blood flows from the left atrium to right atrium, which in turn lowers the blood pressure in the left atrium and lungs. This helps to improve heart failure symptoms. The device and procedure specifically target heart failure patients with preserved (or normal) ejection fraction, which relates to the amount of blood that leaves the heart with each beat. More conventional treatments such as beta blockers and other medications are largely ineffective in heart failure patients with preserved ejection fraction. “When a patient can’t be helped with medications, or still has symptoms despite medications, this simple procedure and device can potentially improve the quality of their life in a safe and long-lasting way,” Dr. Price said. “This trial represents an interdisciplinary approach to heart care which has become more common in recent years,” said Scripps Clinic heart failure specialist Rajeev Mohan, M.D., who is the principal investigator for the La Jolla study site. “It is also the first of its kind to help treat patients with normal ejection fraction heart failure where treatment options are lacking.” The Scripps cardiologists are looking to enroll more patients over the next year in this prospective, randomized controlled, blinded clinical trial, which is seeking to test the device in 380 patients in the United States and 11 other countries. If results from the trial are positive, the device manufacturer will seek permission from the Food and Drug Administration to make the device commercially available in the United States. In an earlier study of the device, participants who were examined a month after implant had lower blood pressure in their lungs, and no safety issues were reported in association with the device. Heart failure is the third leading cause of death attributable to cardiovascular disease in the United States, according to the American Heart Association. About 6.5 million Americans currently are living with heart failure. The inter-atrial shunt device is the latest example of Scripps’ leadership and innovation in cardiology. Ranked No. 1 for heart care in San Diego County by U.S. News and World Report, Scripps Health is the largest provider of heart care in the region, caring for more than 76,000 cardiovascular patients every year. Its Prebys Cardiovascular Institute in La Jolla brings together leading researchers, physicians, staff and technologies in the most advanced center dedicated to heart care on the West Coast. ABOUT SCRIPPS HEALTH Founded in 1924 by philanthropist Ellen Browning Scripps, Scripps Health is a nonprofit integrated health care delivery system based in San Diego, Calif. Scripps treats more than 700,000 patients annually through the dedication of 3,000 affiliated physicians and more than 15,000 employees among its five acute-care hospital campuses, home health care services, 27 outpatient centers and clinics, and hundreds of affiliated physician offices throughout the region. Recognized as a leader in disease and injury prevention, diagnosis and treatment, Scripps is also at the forefront of clinical research. With three highly respected graduate medical education programs, Scripps is a longstanding member of the Association of American Medical Colleges. Scripps has been ranked five times as one of the nation’s best health care systems by Truven Health Analytics. Its hospitals are ranked No. 1 in San Diego County and among the best in the nation by U.S. News & World Report. Scripps also is recognized by Advisory Board, Fortune and Working Mother magazine as one of the best places in the nation to work. More information can be found at www.scripps.org.