Hackensack Meridian Hackensack University Medical Center Now Enrolling Participants in Interventional Cardiology Clinical Trials Under New Structural Heart Program Leadership

Dr. Ryan Kaple joins structural heart colleagues Dr. Tilak Pasala and Dr. Lucy Safi to offer advanced clinical trials and surgical systems that enhance patient outcomes

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.