NewYork-Presbyterian. The University Hospital of Columbia and Cornell.

Find A Physician

Return to Investigational Studies: Percutaneous Valve Replacement Overview

Hospital News

Return to Investigational Studies: Percutaneous Valve Replacement Overview

Research and Clinical Trials

Return to Investigational Studies: Percutaneous Valve Replacement Overview

Health Library

Return to Investigational Studies: Percutaneous Valve Replacement Overview

Clinical Services

Return to Investigational Studies: Percutaneous Valve Replacement Overview

Cardiology

Investigational Studies: Percutaneous Valve Replacement

Everest II

NewYork-Presbyterian Hospital/Weill Cornell Medical Center and NewYork-Presbyterian Hospital/Columbia University Medicl Center are conducting investigational studies – through the Everest II Clinical Trial – of a new device for repair of mitral valve regurgitation (leakage). This device helps to prevent backflow of blood from the left ventricle to the left atrium of the heart by holding together parts of the mitral valve leaflets that form an abnormally large opening. Placement of the investigational device does not require surgery; a catheter is inserted into a blood vessel in the leg through a small incision, and is guided to the heart where the device is positioned. After ensuring that the correct placement has been achieved, the catheter is removed. The patient remains under general anesthesia throughout the procedure and may be discharged within 48 hours. There is no surgical wound – just a small adhesive strip where the catheter was placed.

Partner Trial

The Partner Trial is a multi-center, randomized study to determine the safety and efficacy of the Edwards SAPIEN Transcatheter Heart Valve in high risk, symptomatic patients with severe aortic stenosis. Following evaluation by a cardiologist and a cardiac surgeon patients are determined to be either surgical or non-surgical candidates. Surgical candidates are randomized to undergo either transcatheter aortic valve implantation or surgical aortic valve replacement. Non-surgical candidates are randomized to undergo either transcatheter aortic valve implantation or medical management, which may include balloon valvuloplasty. The randomization which determines study assignment is performed by a computer (like flipping a coin).

The study device is a catheter-delivered heart valve combining a balloon expandable stent and bioprosthetic valve leaflets made of bovine pericardium. Patients enrolled in the Partner Trial have clinical follow-up at 1, 6, and 12 months post- procedure and annually for 5 years.