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Research Trials in the Center for Heart Valve Disease

Researchers in Northwestern Memorial Hospital's Center for Heart Valve Disease at the Bluhm Cardiovascular Institute are conducting clinical research trials to learn more about treating heart valve disease.

Clinical research trials search for new and better ways to understand and treat disease. Participating in a clinical research trial is an informative learning experience for the volunteer. Please consider volunteering in a clinical research trial as your participation will contribute to important advancements of medical knowledge.  The following clinical research trial(s), specific to heart valve disease, are currently recruiting volunteers:

Multi-CenTer Experience with the Rapid Deployment EDWARDS INTUITY Valve System FOR Aortic Valve ReplaceMent (TRANSFORMTM Trial)

Principal Investigators:
Patrick McCarthy, MD (profile opens in new window)
IRB Project Number:
STU00068982 
Description of Research Trial:

Patients may qualify to participate in the TRANSFORM research study if their doctor has determined that their aortic valve needs to be replaced.  The EDWARDS INTUITY Aortic Valve will be used to replace a diseased aortic valve.

The purpose of this research study is to collect information on the safety and effectiveness of a new device, EDWARDS INTUITY Aortic Valve, Model 8300ACA (“Study Device”) and the delivery system used to implant it (EDWARDS INTUITY Delivery System, Model 8300DCA). This device is investigational, meaning that it is not yet approved by the U.S. Food and Drug Administration (FDA).

The Study Device is a bioprosthetic heart valve. This means that it is composed of both biological materials (tissue derived from cows) and man-made materials that form the stent (mesh tube made of metal). The Study Device requires fewer sutures (3) than a traditional aortic valve (15-20) which makes it easier for the surgeon to use a smaller incision in the patient’s chest.  This smaller incision may lead to less blood loss and a reduced wound infection rate. The reduced number of sutures may lead to shorter surgery times.

Up to 650 subjects in up to 25 hospitals located throughout the United States and Canada will be enrolled in the trial.  Participation in the study will last 5 to 8 years with follow up visits at 3 months, 1 year, 2 years, 3 years, 4 years, 5 years and annually thereafter until all participants have completed 5 years of follow up. 

Research Trial Contact Information:
For more information, interested participants and clinicians may contact Susan Herman at (312)926-9769 or e-mail sherman2@nmh.org 

Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for High Surgical Risk Patients (The COAPT Trial)

Principal Investigators:
Mark Ricciardi, MD (profile opens in new window)
IRB Project Number:
STU00064006
Description of Research Trial:

The COAPT Trial is recruiting patients who have moderate-to-severe or severe functional mitral regurgitation (FMR) and have been determined to be at high risk for traditional mitral valve surgery.  FMR occurs when the two leaflets of the mitral valve do not close properly, causing blood to leak backward with each heartbeat.  Since some of the blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood forward.

The purpose of the study is to evaluate (study) the safety and effectiveness of the MitraClip System (“Study Device”) in patients with of mitral regurgitation (MR) that are at high risk for mitral valve surgery.  The Study Device consists of an implantable clip to repair the mitral valve and a delivery catheter (a thin, flexible tube through which the clip is passed into the body).  The Study Device has not been approved by the US Food and Drug Administration (FDA) for use outside of research trials, and is considered experimental in this study.

This is a randomized study which means that there is a 50/50 chance (like flipping a coin) of being assigned to receive the study device or not.  Subjects assigned to the Control (no Device group) may be eligible to receive the Study Device after their 2 year study visit. 

Up to 420 patients at 75 medical centers in North America will participate in this clinical study. We hope to enroll up to 20 participants here at Northwestern.

Participation in the study will last up to 5 years.
Research Trial Contact Information:
For more information, interested participants and clinicians may contact Kate Jordan at (312) 926-0840 or e-mail kjordan@nmh.org 

4D Magnetic Resonance Imaging (MRI) Cardiovascular Flow Imaging 

Principal Investigators:
Patrick McCarthy, MD (profile opens in new window)
IRB Project Number:
STU00057580
Description of Research Trial:

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.

Research Trial Contact Information:
For more information, interested participants and clinicians may contact Berenice Hernandez at (312) 695-1991 or e-mail bhernan1@nmh.org

The PARTNER II Trial: Placement of AoRtic TraNscathetER Valves Trial

Principal Investigators:
S Chris Malaisrie, MD (profile opens in new window)
Charles Davidson, MD (profile opens in new window)
IRB Project Number:
STU44856
Description of Research 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 or are inoperable (risk is too high for surgery). 

The purpose of this research study is to evaluate the safety and effectiveness of the Edwards SAPIEN 3™ Transcatheter Heart Valve (THV), Model 9600TFX and associated delivery systems: Commander (transfemoral access – through the leg) and Certitude (transapical access – through the side of the chest) or transaortic (through the front of the chest).  A transcatheter heart valve is one that is delivered through the blood vessels and placed into the heart, rather than being placed in the heart through conventional (standard) open-chest surgery. 

The study device is a bioprosthetic heart valve. This means it is composed of both biological materials (tissue derived from cows) that form the valve leaflets to direct the flow of blood in your heart and man-made materials that form the stent (mesh tube made of metal) that holds the device in its intended position in your heart. 

The study device is designed to be implanted through three (3) different routes depending on each person’s anatomy to ensure safety:

1)      Transfemorally- the device is delivered by means of a catheter (small tube) that is placed in an artery (blood vessel) in your groin and then maneuvered through other arteries to your heart where it is expanded to replace your diseased aortic heart valve.

2)      Transaortically- the device is placed through an incision (thoracotomy) on the front of the chest and delivered by a catheter through your aorta directly to your stenotic aortic valve

3)      Transapically- the device is delivered through an incision (thoracotomy) between the ribs, on the left side of the chest to access the heart directly.

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). 

Research Trial Contact Information:
For more information, interested participants and clinicians may contact Bosede Agbaje-Williams, RN, BSN at (312) 695-1806 or e-mail bagbajew@nmh.org or Maryan DeAngelis, RN, BSN, CCRP at (312) 694-7645 or e-mail mdeangel@nmh.org.

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

Principal Investigator:
S Chris Malaisrie, MD (profile opens in new window)
IRB Project Number:
STU00035943
Description of Research Trial:

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.

Research Trial Contact Information:
For more information, interested participants and clinicians may contact Carmen Diaz at (312) 926-4801 or e-mail cadiaz@nmh.org

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

Principal Investigator:
S Chris Malaisrie, MD (profile opens in new window)
IRB Project Number:
STU00014302
Description of Research Trial:

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.

Research Trial Contact Information:
For more information, interested participants and clinicians may contact Carmen Diaz at (312) 926-4801 or e-mail cadiaz@nmh.org

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

Principal Investigator:
Vera H. Rigolin, MD (profile opens in new window)
IRB Project Number:
414-010
Description of Research Trial:

This research study is looking for patients with heart valve disease. The purpose of this study is to evaluate the heart chambers by using a new echocardiography technique (3D echocardiography). Echocardiography (echo for short) is a safe and painless way of evaluating heart function that cardiologists have been using for many years. Images generated from the new 3D echo technique contain more information about the structure of the heart, which will help us better understand the changes that occur in the heart as a result of leaking heart valves. Eligible participants for this study include those with moderate or severe leaking of the heart valves. Participation in this study will include outpatient visits for echocardiograms every 6-12 months. Outpatient echocardiograms will be performed more frequently if participants require surgery to correct the valve problem.

Research Trial Contact Information:
For more information, interested participants and clinicians may contact Dr. Vera Rigolin at (312) 926-6314

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This page last updated 

February 11, 2014
Feinberg School of Medicine home page

Bluhm Cardiovascular Institute - Clinical Trials Unit (CTU)
Feinberg School of Medicine
676 North Saint Clair Street, Suite 1700
Chicago, IL 60611-2969
Phone: (312) 926-4000
Email: heartresearch@northwestern.edu

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