Newswise — Hackensack Meridian Hackensack University Medical Center is currently enrolling participants in two cardiovascular clinical trials and is now utilizing a new surgical system to improve accuracy and safety during a variety of interventional cardiology procedures.
These leading-edge therapeutic options have been implemented under the leadership of interventional cardiologist Ryan K. Kaple, M.D., FACC, FSCAI, who joined the Hackensack University Medical Center team as director of the Structural and Congenital Heart Program in May 2022.
Dr. Kaple is an internationally recognized expert in transcatheter aortic valve replacement and minimally invasive mitral and tricuspid valve therapies. He joins Structural and Congenital Heart Program colleagues Tilak K.R. Pasala, M.D., FACC, FSCAI, associate director, Structural and Congenital Heart Program and principal investigator on both clinical trials, and Lucy Safi, D.O., FACC, FASE, director of Interventional Echocardiography, in offering advanced, minimally invasive structural heart care.
As a leading provider of cardiovascular care, ranked #43 in the nation, the highest ranked medical center in New Jersey for Cardiology & Heart Surgery by U.S. News & World Report in 2022, Hackensack University Medical Center is frequently able to provide patients with leading-edge clinical trials like these.
Cardiac Implants Percutaneous Ring Annuloplasty System Clinical Trial
Hackensack University Medical Center is the only center in New Jersey — and one of only four in the U.S. — to participate in a clinical trial titled, “Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System.” The study will determine the effectiveness of a minimally invasive device to treat functional tricuspid regurgitation (FTR). FTR occurs when the tricuspid valve doesn’t close properly, leading to a backflow of blood through the valve.
Using a thin tube called a catheter that is inserted into a vein, the device is implanted into the tricuspid annulus, which is the ring-shaped support structure of the tricuspid valve. Approximately three months after implantation, a second procedure is performed to adjust the device and tighten the annulus, resolving the backflow of blood.
“This is one of the few transcatheter tricuspid valve devices in the U.S., and we are proud to be the only site in New Jersey to offer this innovative clinical trial,” said Dr. Pasala.
AccuCinch® Ventricular Restoration System for Heart Failure (CORCINCH-HF Study)
The CORCINCH-HF Study is designed to evaluate the effectiveness of the AccuCinch Ventricular Restoration System in patients who have heart failure with reduced ejection fraction, which limits the heart’s ability to efficiently squeeze and pump blood to the rest of the body. The AccuCinch device is implanted using a catheter and helps tighten the muscles of the heart’s enlarged left ventricle, improving the heart’s ability to squeeze.
“The goal of this device is to reduce the size of the left ventricle, which will reduce heart failure symptoms and prevent progression of the disease,” said Dr. Kaple.
SafeCross™ Transseptal Radiofrequency Puncture and Steerable Balloon Introducer System
Hackensack University Medical Center now uses the SafeCross septal puncture and access system, which allows interventional cardiologists to access the left chamber of the heart more safely and accurately during procedures.
“In order to access the left atrial chamber of the heart, we have to send a catheter through a vein in the patient’s leg into the right atrial chamber and create a small surgical pathway through the atrial septum, which separates the upper chambers of the heart,” said Dr. Kaple. “The SafeCross system allows us to ‘steer’ the device for improved accuracy, and the radiofrequency energy enables us to safely create a small hole without the use of a needle.”
Dr. Kaple said SafeCross can be used in any interventional cardiology procedure that requires access to the left atria, including electrophysiology ablation procedures, left atrial appendage closure procedures, Watchman procedures, MitraClip procedures and any other catheter-based mitral valve procedure.
“I’m proud to join a team of experts who are committed to offering the latest clinical trials and are early adopters of advanced technology that can improve patient safety and outcomes,” said Dr. Kaple.
ABOUT HACKENSACK MERIDIAN HEALTH HACKENSACK UNIVERSITY MEDICAL CENTER
Hackensack University Medical Center, a 781-bed nonprofit teaching and research hospital, was Bergen County’s first hospital founded in 1888. It was also the first hospital in New Jersey and second in the nation to become a Magnet®-recognized hospital for nursing excellence, receiving its sixth consecutive designation from the American Nurses Credentialing Center. The academic flagship of the Hackensack Meridian Health network, Hackensack University Medical Center is Nationally-Ranked by U.S. News & World Report 2022-2023 in four specialties, more than any other hospital in New Jersey. The hospital is home to the state's only nationally-ranked Urology and Neurology & Neurosurgery programs, as well as the best Cardiology & Heart Surgery program. It also offers patients nationally-ranked Orthopedic care and one of the state’s premier Cancer Centers (John Theurer Cancer Center at Hackensack University Medical Center). Hackensack University Medical Center also ranked as High-Performing in conditions such as Acute Kidney Failure, Heart Attack (AMI), Heart Failure, Pneumonia, chronic obstructive pulmonary disease (COPD), Diabetes and Stroke. As well as High Performing in procedures like Aortic Valve Surgery, Heart Bypass Surgery (CABG), Colon Cancer Surgery, Lung Cancer Surgery, Prostate Cancer Surgery, Hip Replacement and Knee Replacement. This award-winning care is provided on a campus that is home to facilities such as the Heart & Vascular Hospital; and the Sarkis and Siran Gabrellian Women’s and Children’s Pavilion, which houses the Donna A. Sanzari Women’s Hospital and the Joseph M. Sanzari Children’s Hospital, ranked #1 in the state and top 20 in the Mid-Atlantic Region in the U.S. News & World Report’s 2022-23 Best Children’s Hospital Report. Additionally, the children’s nephrology program ranks in the top 50 in the United States. Hackensack University Medical Center is also home to the Deirdre Imus Environmental Health Center and is listed on the Green Guide’s list of Top 10 Green Hospitals in the U.S. Our comprehensive clinical research portfolio includes studies focused on precision medicine, translational medicine, immunotherapy, cell therapy, and vaccine development. The hospital has embarked on the largest healthcare expansion project ever approved by the state: Construction of the Helena Theurer Pavilion, a 530,000-sq.-ft., nine-story building, which began in 2019. A $714.2 million endeavor, the pavilion is one the largest healthcare capital projects in New Jersey and will house 24 state-of-the-art operating rooms with intraoperative MRI capability, 50 ICU beds, and 175 medical/surgical beds including a 50 room Musculoskeletal Institute.
ABOUT HACKENSACK MERIDIAN HEALTH
Hackensack Meridian Health is a leading not-for-profit health care organization that is the largest, most comprehensive and truly integrated health care network in New Jersey, offering a complete range of medical services, innovative research and life-enhancing care. The network has 18 hospitals and more than 500 patient care locations, which include ambulatory care centers, surgery centers, home health services, long-term care and assisted living communities, ambulance services, lifesaving air medical transportation, rehabilitation centers, urgent care centers, physician practice locations, and a fitness and wellness center. With more than 35,000 team members and 7,000 physicians, Hackensack Meridian Health is a distinguished leader in health care philanthropy and committed to the health and well-being of communities throughout New Jersey.
The network’s notable distinctions include having more U.S. News-ranked hospitals than any other health system in New Jersey, as ranked by U.S. News & World Report, 2022-23. Hackensack University Medical Center is nationally-ranked by U.S. News & World Report in four specialties, more than any other hospital in New Jersey. Joseph M. Sanzari Children’s Hospital at Hackensack University Medical Center, and K. Hovnanian Children’s Hospital at Jersey Shore University Medical Center, are ranked #1 in the state and top 20 in the Mid-Atlantic Region by U.S. News & World Report’s 2022-23 Best Children’s Hospital Report. Additionally, their combined nephrology program ranks in the top 50 in the United States. To learn more, visit www.hackensackmeridianhealth.org.
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