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Piedmont Performs Its First Procedure as Part of CLASP IID Trial Involving Transcatheter Mitral Valve Repair System

Atlanta (September 21, 2020) – Piedmont Healthcare announced that it performed its first transcatheter mitral valve repair (TMVR) procedure on Aug. 13 as part of the CLASP IID pivotal trial at Piedmont Atlanta Hospital by structural interventional cardiologists Pradeep Yadav, M.D. and Vivek Rajagopal, M.D and cardiac surgeon Vinod Thourani, M.D. The CLASP IID trial will evaluate the Pascal TMVR system, which is produced by Edwards Lifesciences for patients with degenerative mitral valve regurgitation.

Mitral Regurgitation (MR) is a condition that occurs when leaflets of the mitral valve in the heart do not close properly and blood flows backwards, making it difficult for the heart to move blood through the body efficiently. Estimates are that MR affects five in every 10,000 people.

For patients suffering from MR, the increased pressure in the heart, according to the American Heart Association, can increase pressure in the veins leading from the lungs to the heart (pulmonary veins). If regurgitation is severe, increased pressure may result in congestion, or fluid build-up, in the lungs – resulting in a serious and debilitating condition.

Dr. Yadav is the Principal Investigator at Piedmont Atlanta for the study.

“We are excited to make this innovative therapy available for our patients and continue to be a leader in research that advances minimally invasive options for the care of valvular disease,” Dr. Yadav said. “It is Piedmont’s goal through investments made in the Marcus Tower, the Marcus Heart Valve Center and the Samsky Invasive Cardiovascular Services Center to remain positioned at the cutting edge of clinical research involving the heart.”

Transcatheter mitral valve repair can treat the heart valve without open heart surgery. The procedure is done through a small incision in the leg, allowing the doctor to insert a small device through the vein up to the heart. The trial is designed for patients with symptomatic moderate to severe mitral regurgitation who may not be ideal candidates for mitral valve surgery and may be eligible for transcatheter mitral valve repair.

The trial is estimated to enroll 1,275 participants and its primary completion date is set for Dec. 31, 2023.