Hoag remains safe and ready to care for you. View COVID-19 information and updates.

Hoag Begins Enrolling Patients with Degenerative Mitral Valve Disease in Clinical Trial Using a Less Invasive Surgical Treatment

Categories: Press Room

NEWPORT BEACH, Calif., June 29, 2021 --- Hoag is now enrolling patients in a clinical trial to study an innovative surgical procedure that would allow surgeons to repair a patient’s mitral valve without open-heart surgery.

The RESTORE clinical trial, in collaboration with Edwards Lifesciences, will evaluate the safety and effectiveness of the investigational HARPOON™ Beating Heart Mitral Valve Repair System for patients with severe degenerative mitral valve regurgitation, a condition commonly caused by mitral valve prolapse, which prevents the valve from closing properly and causes blood to leak backwards into the lungs causing shortness of breath.

“If successful, the new system will provide another minimally invasive approach to help surgeons repair patients’ mitral valves, while the heart is still beating. Clinical trials like these continue to push surgical innovation to expand surgical options to more people, ultimately improving patient outcomes and quality of life.” said Anthony D. Caffarelli, M.D., director of the Elaine & Robert Matranga Aortic Center, director of Hoag Cardiovascular Surgery, the Newkirk Family Endowed Chair in Aortic Care, and principal investigator for the trial. “This device, and other minimally invasive technologies that are being developed, provide exciting new options to appropriate patients that could lower their risk of heart disease. For these select patients, the results are promising.”

Hoag offers a variety of options to treat mitral valve disease including traditional heart surgery, minimally invasive surgery, minimally invasive robotic repair and catheter based technology for those who are too frail for surgery.

“Our goal is to match patients to the right procedure for them, to ensure the best possible outcomes.” said Dr. Caffarelli.

Hoag was among 40 hospitals chosen to participate in the trial, a testament to the Jeffrey M. Carlton Heart & Vascular Institute’s commitment to advancing treatment options for patients with heart valve disease.

The Society of Thoracic Surgeons ranked Hoag’s Cardiovascular Surgery Program in the highest category for quality and successful outcomes, achieved by only 1.8% of hospitals nationwide, and U.S. News & World Report consistently ranks Hoag as high performing in Abdominal Aortic Aneurysm Repair, Aortic Valve Surgery, Heart Bypass Surgery, Heart Failure and Transcatheter Aortic Valve Replacement (TAVR)​.

For more information about the RESTORE trial, call 949-764-8258.


Hoag’s Jeffrey M. Carlton Heart and Vascular Institute (JMCHVI) is one of the preeminent cardiovascular centers on the West Coast, and is well respected for delivering quality care and exceptional patient outcomes in the areas of valve disease, vascular disease and cardiac arrhythmia. The JMCHVI has achieved international and national accreditation for many of its programs, including being named one of the 50 Top Cardiovascular Hospitals in the nation by IBM Watson Health™ and the American Heart Association's Get with the Guidelines® Heart Failure Gold Plus Quality Achievement Award. U.S. News & World Report ranked Hoag high performing in the following specialties: Abdominal Aortic Aneurysm Repair, Aortic Valve Surgery, Heart Bypass Surgery, Heart Failure & Transcatheter Valve Replacement. The Society of Thoracic Surgeons placed Hoag in the highest category for quality cardiac surgery, a rating achieved by only 5 percent of hospitals nationwide. Hoag's physicians perform more surgeries and procedures with better outcomes than any other hospital in the county.


Hoag is a nonprofit, regional health care delivery network in Orange County, California, that treats more than 30,000 inpatients and 480,000 outpatients annually. Hoag consists of two acute-care hospitals – Hoag Hospital Newport Beach, which opened in 1952, and Hoag Hospital Irvine, which opened in 2010 – in addition to nine health centers and 14 urgent care centers. Hoag has invested $261 million in programs and services to support the underserved community within the past five years, including areas like mental health, homelessness, transportation for seniors, education, and support for single mothers. Hoag is a designated Magnet® hospital by the American Nurses Credentialing Center (ANCC). Hoag offers a comprehensive blend of health care services that includes five institutes providing specialized services in the following areas: cancer, heart and vascular, neurosciences, women’s health, and orthopedics through Hoag’s affiliate, Hoag Orthopedic Institute, which consists of an orthopedic hospital and two ambulatory surgical centers. In the 2020 - 2021 U.S. News & World Report Best Hospitals Rankings, Hoag is the highest ranked hospital in Orange County and the only OC hospital ranked in the Top 10 in California. For an unprecedented 23 years, residents of Orange County have chosen Hoag as one of the county’s best hospitals in a local newspaper survey. Visit www.hoag.org for more information.