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 Drs. Robert Kipperman and Philippe Genereux, cardiac imaging specialists Drs. Konstantinos Koulogiannis and Leo Marcoff, and cardiovascular surgeon Dr. John Brown III have been instrumental in pioneering and evaluating this novel procedure.
Morristown Medical Center structural heart disease program co-director Dr Robert Kipperman said: “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.
“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.
Source: Company Press Release
