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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. The following clinical research trials, specific to heart valve disease, are currently recruiting volunteers. 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. |
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| Name of Research Trial: | The PARTNER Trial: Placement of AoRtic TraNscathetER Valves Trial |
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| Principal Investigator: | Patrick McCarthy, MD
Charles Davidson, MD |
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| IRB Project Number: | STU00001119 |
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| Description of Research Trial: | This study is looking for participants with severe aortic stenosis (narrowing of the aortic valve resulting in the obstructed passage of blood) who are considered high risk candidates for conventional (standard) open-heart surgery. The purpose of this study is to evaluate the safety and effectiveness of the Edwards SAPIEN™ Transcatheter Heart Valve (THV). The THV is intended to treat patients who are at high operative risk for traditional aortic valve replacement (AVR) surgery. The standard medical treatments generally available to non-surgical patients with aortic stenosis may temporarily alleviate symptoms, but will not cure aortic stenosis permanently. The THV is an investigational device, which means the valve is being studied and not for sale commercially. Data is being collected on the valve for approval by the Food and Drug Administration (FDA). The Edwards SAPIEN™ THV is a prosthetic heart valve, meaning that it is an artificial device, made to replace diseased aortic heart valves. The valve consists of a stent (made of stainless steel) to hold the device in its intended position and valve leaflets (made of biological material derived from cows) to direct the flow of blood in the heart. The implantation of the valve does not require open-heart surgery and can be done in a catheterization laboratory (as used for balloon angioplasty procedures) by a transfemoral approach (through the leg) or transapical approach (through an incision in 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 occur at Northwestern Memorial Hospital (NMH). |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Nancy Schoenecker, RN at (312) 695-1806 or e-mail n-schoenecker@northwestern.edu |
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| Name of Research Trial: | RESTOR-MV: Randomized Evaluation of a Surgical Treatment for Off-pump Repair of the Mitral Valve (RESTOR-MV) |
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| Principal Investigator: | Edwin McGee, MD |
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| IRB Project Number: | 1654-001 |
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| Description of Research Trial: | This study is looking for participants, 18 to 80 years, who are scheduled for coronary artery bypass grafting (also known as CABG) and have mitral valve regurgitation (a leaky heart valve). The purpose of this study is to compare the safety and effectiveness of an investigational device (Coapsys®) to standard therapy for treatment of patients with moderate to severe mitral regurgitation. The Coapsys device is implanted in the operating room while you are under general anesthesia for your CABG surgery. The implant procedure involves the placement of 2 pads that sit on the outside of the heart. These pads are connected by a flexible chord which passes through your heart. The pads are pulled towards one another, decreasing the distance between the pads. Pulling these pads together is intended to change the shape of your valve and reduce the leak. This study has been reviewed by the Food and Drug Administration (FDA); however, the Coapsys device is considered experimental and has not been approved by the FDA. Participation in this study will involve 5 postoperative study visits to the clinic and will last approximately 3 years, or until study closure. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Nancy Schoenecker, RN at (312) 695-1806 or e-mail n-schoenecker@northwestern.edu |
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| Name of Research Trial: | Serial Assessment of Left Ventricular Volumes and Mass by Three Dimensional Echocardiography in Patients with Valvular Heart Disease |
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| Principal Investigator: | Vera H. Rigolin, MD |
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| IRB Project Number: | 414-010 |
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| 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. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Dr. Vera Rigolin at (312) 926-6314 |
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