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

By Trial Site News

June 29, 2021

The Condition

Mitral valve prolapse, also known as click-murmur syndrome, Barlow’s syndrome, balloon mitral valve, or floppy valve syndrome, manifests as bulging of one or both of the mitral valve flaps (leaflets) into the left atrium during the contraction of the heart. For more details, follow the link to the description at the American Heart Association. This condition prevents the valve from closing properly and thus triggers blood to leak backward into the lungs leading to shortness of breath.

The Study

This prospective, multicenter non-randomized study (NCT04375332) is designed to evaluate the safety and effectiveness of the HARPOON Beating Heart Mitral Repair System in patients with severe degenerative mitral regurgitation (DMR). Targeting 360 participants, the study is sponsored by Edwards Lifesciences, a medical devices company.

The study started at the end of 2020 and runs all the way through till December, 2027. The study’s primary endpoint centers on “Composite Safety Endpoints” that is during the time frame of discharge from the hospital or 30-days following the index procedure, whichever is longer. More specifically the composite safety endpoint is defined as “freedom-from all-cause mortality, stroke, acute kidney injury (AKI), major bleeding, new permanent pace-maker implantation, deep sternal wound infection (DSWI), or wound infection requiring surgical intervention, and prolonged mechanical ventilation.

The inclusion and exclusion criteria for this study can be reviewed here.

“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.”

The overall study is led by two principal investigators including Vinod H. Thourani, MD, Department of Cardiovascular Surgery at Piedmont Heart Institute and Konstantinos Koulogiannis, MD, Department of Cardiovascular Medicine at the Gagnon Cardiovascular Institute.

Hoag Point of View

TrialSite showcases Hoag Hospital, which initially was not included in the study, or not disclosed in Clinicaltrials.gov. Now the state-of-the-art hospital participates in this important effort. 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).

About Jeffrey M. Carlton Heart and Vascular Institute

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. In addition, the Society of Thoracic Surgeons placed Hoag in the highest category for quality cardiac surgery, a rating achieved by only 5% of hospitals nationwide. Hoag’s physicians perform more surgeries and procedures with better outcomes than any other hospital in the county.

About Hoag

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.

Call to Action: For more information about the RESTORE trial, call 949-764-8258.

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