Research Trials in the Center for Heart Valve Disease

4D Magnetic Resonance Imaging (MRI) Cardiovascular Flow Imaging 

This study is looking for patients with known heart disease. The purpose of this study is to use new MRI technology, known as 4D MRI, to help researchers develop clearer and more accurate pictures of the heart.  MRI is a widely used non-invasive clinical test that uses magnetic fields and radio waves rather than x-rays to provide detailed pictures of internal organs, including the heart.  When a doctor looks at these images, he/she can gather information that can be used to diagnose certain diseases of the body.

Approximately 500 subjects will be enrolled in the study at Northwestern.

The PARTNER II Trial: Placement of AoRtic TraNscathetER Valves Trial

The PARTNER II study is recruiting participants with severe aortic stenosis (narrowing of the aortic valve resulting in obstructed blood flow) who are considered high-risk candidates for conventional (standard) open-heart surgery. 

The purpose of the PARTNER II study is to assess the safety and effectiveness of transcatheter (delivered through the blood vessels) implantation of bioprosthetic (composed of biological and man-made materials) aortic valves (THV).  These are investigational devices intended to treat patients who are at high risk for the traditional operation for aortic valve replacement (AVR) surgery. 

The study devices are the Edwards SAPIEN™ and SAPIEN XT™ prosthetic heart valves.  They are artificial devices made to replace your diseased aortic heart valve.  Each valve consists of a stent (mesh tube made of metal) to hold the study device in its intended position and valve leaflets (made of biological material derived from cows) to direct the flow of blood in your heart.  The THV is delivered by means of a catheter (small tube) that is placed in an artery (blood vessel) in your leg leading to your aortic heart valve.

Transfemoral (through a blood vessel in the leg) implantation of the study device does not require open heart surgery and is performed in a catheterization laboratory or operating room.

Participation in this study will last for a minimum of 5 years with at least 7 follow-up visits, which will occur at Northwestern Memorial Hospital (NMH).

Magna Mitral 23: Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX

The purpose of this research study is to collect information on the safety and effectiveness of a new device, the size 23 mm Carpentier-Edwards® PERIMOUNT® Magna Mitral Bioprosthesis, model 7000/7000TFX.  This device is investigational, meaning that it is not yet approved by the U.S. Food and Drug Administration (FDA). 

Patients may qualify to participate in this research study if their doctor has determined that their mitral valve needs to be replaced.  The study device will be used to replace diseased mitral valve or a previously implanted prosthesis.  Subjects will be followed for 5 years after they receive the study device.  The overall duration of this study will be from the time the first subject is enrolled until the time that the last subject enrolled completes their 5-year follow up visit.  Between 15 and 20 patients will participate in this study at up to 2 to 5 hospitals.  We hope to enroll up to 10 subjects at Northwestern University.

Post-Approval Study Protocol Study # 2006-05: Carpentier-Edwards® Perimount Magna® Mitral Pericardial Bioprostheses Models 7000/7000TFX and Carpentier-Edwards® Perimount Magna® Mitral Ease™ Pericardial Bioprosthesis Model 7200TFX

The purpose of this study is to evaluate the Carpentier-Edwards® PERIMOUNT Magna® Mitral Bioprosthesis (also referred to as Magna Mitral Valve), which has been approved by the U.S. Food and Drug Administration (FDA).  The purpose of this research study is to learn about the safety of the Magna Mitral Valve and how well it works.

Patients may qualify to participate in this research study if their doctor has determined that their mitral valve needs to be replaced.  The Magna Mitral valve will be used to replace a diseased mitral valve or a previously implanted prosthesis.  This valve replacement surgery is not part of the study.  Patients will be asked to sign a separate consent for the valve replacement during their visit for valve replacement surgery.

Participation in the study will involve a baseline visit at the time of surgery, a follow-up visit three to six months after the surgery, and an annual visit for eight years.

Serial Assessment of Left Ventricular Volumes and Mass by Three Dimensional Echocardiography in Patients with Valvular Heart Disease