CLASP IID Trial Will Evaluate Edwards PASCAL Transcatheter Mitral Valve Repair System
December 3, 2018, Morristown, NJ – Atlantic Health System’s Morristown Medical Center today announced that its internationally recognized cardiac team performed the world’s first transcatheter mitral valve repair (TMVr; a minimally invasive, catheter-based procedure to repair the heart’s mitral valve) in the CLASP IID Pivotal Trial.
The CLASP IID Trial led by national Principal Investigators Drs. Linda Gillam (Morristown Medical Center), Scott Lim (University of Virginia), and Rob Smith (The Heart Hospital Baylor Plano), will evaluate Edwards novel PASCAL Transcatheter Mitral Valve Repair (System for patients with degenerative mitral valve regurgitation.
Currently, the standard of care for this condition is open-heart surgery, which is associated with a longer recovery time than non-surgical approaches and is not always possible in sick patients. TMVr, a procedure involving heart valve repair via a catheter inserted through the major vein of the leg, offers a safe and less invasive alternative compared to open heart surgery.
Morristown Medical Center’s Structural Heart Team, led by interventional cardiologists Robert Kipperman, MD and Philippe Genereux, MD, cardiac imaging specialists Konstantinos Koulogiannis, MD, and Leo Marcoff, MD, and cardiovascular surgeon John Brown III, MD, have been instrumental in pioneering and evaluating this novel procedure.
“As a nationally ranked heart hospital, Morristown Medical Center is proud to be the first hospital in the world to implant this device as part of this pivotal trial,” said Dr. Robert Kipperman, Co-Director, Structural Heart Disease Program, Morristown Medical Center, and an investigator on the trial. “Our cardiac team was chosen for this prestigious opportunity based on our expertise, excellent outcomes, best-in-class imaging, and extensive experience with transcatheter valve replacement or repair procedures.”
“We are extremely honored to implant the first device in this trial and to make this therapy available for those we care for,” said Dr. Linda D. Gillam, MPH, FACC, the Dorothy and Lloyd Huck Chair of the Department of Cardiovascular Medicine, Morristown Medical Center, Medical Director of the Cardiovascular Service Line for Atlantic Health System, and one of the Principal (lead) Investigators of the CLASP IID pivotal trial.
Mitral valve regurgitation occurs when blood flows backward through the mitral valve and into the atrium each time the left ventricle contracts, increasing blood volume and pressure in the left atrium. It can cause shortness of breath and reduce the amount of blood that moves forward out of the heart to the body. If left untreated, severe mitral regurgitation can lead to declining heart function and heart failure.
Because of its infrastructure to support research through the Atlantic Center for Research, volume, and earned credibility with the sponsors of trials—pharmaceutical, biotech, or medical device companies—Morristown Medical Center is able to offer cutting edge and novel clinical trials for the treatment of heart valve disease.
Clinical trials offer patients access to the latest treatment advancements—like this minimally invasive, catheter-based treatment approach to repair the mitral valve. Though participation in a clinical trial may involve risks, research patients are monitored closely and at regular intervals in accordance with rigorous scientific criteria. The cardiac research team works in conjunction with strict United States Food and Drug Administration guidelines to ensure the safety of patients who participate in clinical trials.
To learn more about the CLASP IID Trial and current trials for patients with aortic stenosis, mitral regurgitation, heart failure, or cardiomyopathy, call the Valve Center at 973-971-7001.
About Heart Care at Atlantic Health System
The Gagnon Cardiovascular Institute at Morristown and Overlook Medical Centers, part of Atlantic Health System, is home to New Jersey’s largest cardiac surgery program, providing patients with world-class medical experts and award-winning cardiovascular diagnostic and treatment services. Specializing in open-heart, minimally invasive and non-invasive procedures, Gagnon offers its patients individualized care at a hospital that was named one of America’s 20 Best Hospitals for Cardiology and Cardiac Surgery by US News and World Reports and one of America’s 100 Best Hospitals for Cardiac Care by Healthgrades. Nationally ranked in cardiology since 2012, the heart care team at Atlantic Health System includes cardiologists with expertise in multiple disciplines, cardiac surgeons, vascular specialists and allied health professionals.
About Atlantic Health System
Atlantic Health System, headquartered in Morristown, N.J., is an integrated health care delivery system powered by a workforce of over 16,500 team members and 4,800 affiliated physicians dedicated to building healthier communities. The system serves a population of five million, with over 400 sites of care, including six hospitals: Morristown Medical Center, Overlook Medical Center, Newton Medical Center, Chilton Medical Center, Hackettstown Medical Center and Goryeb Children’s Hospital.
Atlantic Health System provides care for the full continuum of health care needs including 11 urgent care centers, Atlantic Rehabilitation and Atlantic Home Care and Hospice. Facilitating the connection between these services on both land and air is the transportation fleet of Atlantic Mobile Health.
In addition to the employed workforce, Atlantic Alliance, a Clinically Integrated Network, represents more than 2,500 health care providers throughout northern and central NJ. Atlantic Health System leads the Healthcare Transformation Consortium, a partnership of six regional hospitals and health systems dedicated to improving access and affordability, and is a founding member of both the PIER Consortium – Partners in Innovation, Education, and Research – a streamlined clinical trial system that will expand access to groundbreaking research across six health systems in New Jersey and Pennsylvania and AllSpire Health Partners, a consortium of five leading health care organizations dedicated to serving patients, families and communities in New Jersey, New York, Maryland and Pennsylvania.