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Researchers in Northwestern Memorial Hospital's Center for Atrial Fibrillation at the Bluhm Cardiovascular Institute are conducting clinical research trials to learn more about treating atrial fibrillation. The following clinical research trial(s), specific to atrial fibrillation, 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: | A Randomized Controlled Trial of Radiofrequency Ablation for the Treatment of Paroxysmal Atrial Fibrillation Using the Bard High Density Mesh Ablation System |
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| Principal Investigator: | Alan H. Kadish, MD |
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| IRB Project Number: | STU00003303 |
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| Description of Research Trial: | This study seeks individuals with Paroxysmal Atrial Fibrillation (PAF); a condition characterized by an irregular heart beat. The goal of this study is to determine the safety and effectiveness of a new, investigational (not yet approved by the FDA) ablation device for treating PAF. Ablation is a procedure where your doctor inserts a catheter (a small, flexible tube) into your heart and uses a special machine to direct energy to tiny areas of the heart muscle that cause abnormal rhythms. The energy destroys (burns) these tiny areas of heart muscle, interrupting the pathway of the abnormal rhythm. Ablation is a common procedure to treat abnormal heart rhythms. As a subject in this study, you will either receive the ablation procedure using the device being researched or an anti-arrhythmic drug treatment. Participation in this study will last approximately one year. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Heather Kleinschmit, RN at (312) 926-9413 or e-mail h-kleinschmit@northwestern.edu |
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| Name of Research Trial: | An Evaluation of the Cardioblate® Closure™ Device in Occlusion of the Left Atrial Appendage (LAA) |
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| Principal Investigator: | Richard Lee, MD |
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| IRB Project Number: | STU00006915 |
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| Description of Research Trial: | This investigational study will evaluate whether the Cardioblate® Closure™ Device can be used to occlude the Left Atrial Appendage (LAA) and to further understand the study device performance. Patients may be able to participate in this study if they are already scheduled to have cardiac surgery and their surgeon believes they may be an appropriate candidate for LAA occlusion. The LAA is a part of the heart that serves as a reservoir (container) for blood flowing in and out of the left ventricle. As the blood flows in and out of the LAA, sometimes the blood becomes trapped in the area and forms a blood clot (blood that has been converted from a liquid to a solid state), and could potentially increase the chances of having a stroke. A stroke occurs when a blood clot blocks an artery (a blood vessel that carries blood from the heart to the body) or a blood vessel (a tube through which the blood moves through the body) breaks, interrupting blood flow to an area of the brain. The sponsor of this study has developed a device (Cardioblate® Closure™ Device) which will occlude (close off) the LAA with a small band, much like a rubber band. This small band will be placed around the LAA to stop blood from moving in and out of the appendage, thus potentially reducing the formation of blood clots. Participation in this study will last for three months and will involve a total of four visits. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Heather Kleinschmit, RN at (312) 926-9413 or e-mail h-kleinschmit@northwestern.edu |
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| Name of Research Trial: | Development and Validation of Methods for Evaluation of Atrial Radiofrequency Ablation Lesions using a 3 Tesla MRI System |
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| Principal Investigator: | Jason Jacobson, MD |
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| IRB Project Number: | STU00003669 |
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| Description of Research Trial: | This study is looking for patients with atrial fibrillation that are scheduled to have an ablation procedure for treatment. With atrial fibrillation, electrical impluses don't follow a normal pathway through the heart causing the upper chambers of the heart (atria) to beat too fast in a disorganized, irregular way. Medicine often helps treat AF. In some cases, however, the most effective treatment is to destroy the tissue that causes the irregular impulses using radiofrequency energy (RF ablation). RF ablation uses radio waves to create small scars on the heart's surface that interrupt the abnormal electrical signals and restore a normal heart rhythm. This procedure is often called cardiac ablation. The purpose of this study is to use Magnetic Resonance Imaging (MRI) to view lesions after the RF ablation procedure. MRI is a widely used clinical test that uses magnetic fields and radio waves to provide detailed pictures of the body. The results of the cardiac MRI may provide doctors with information that can be used to help determine the most effective ablation technique for treatment of atrial fibrillation. Participation in this study will last for about 3 months and will involve two follow-up visits. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact the principal investigator, Dr Jacobson at 312-695-0054 or e-mail jasonjacobson@nmff.org |
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Name of Research Trial:
| Medtronic Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF) Study |
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| Principal Investigator: | Richard Lee, MD |
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| IRB Project Number: | STU00001185 |
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| Description of Research Trial: | This investigational study is looking for patients who have permanent atrial fibrillation (AF) and are scheduled for open heart surgery.AF is an abnormal heart rhythm. During AF the upper chambers of the heart (atria) beat too fast in a disorganized, irregular way. Signals traveling from the atria cause the lower heart chambers (ventricles) to beat. AF can cause the ventricles to beat irregularly and fast, which can cause symptoms like pounding or fluttering in the chest, dizziness, fatigue, chest pain or discomfort, and/or shortness of breath. Since AF affects blood flow, there is a chance that clots can form increasing the risk for stroke. The purpose of this investigational study is to evaluate the safety and effectiveness of the Cardioblate® Surgical Ablation System for treatment of permanent AF. Studies have shown that taking drugs to stay out of AF does not decrease the chance of death. The sponsor of this study, Medtronic, Inc., is conducting this investigational study to measure if there are benefits to having surgery to treat AF with the Medtronic Cardioblate® Surgical Ablation System. No surgical device has been proven safe and effective for treating AF in a clinical research study. Participants in this study will undergo their scheduled open heart surgery plus the Medtronic Cardioblate® Surgical Ablation System (investigational device) to treat permanent AF, during the same procedure. Participation in the study will last up to 5 years after open heart surgery. Subjects will need to return to Northwestern Memorial Hospital (NMH) for 3 follow-up visits and will be contacted after that by telephone yearly for follow-up information. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Amy Miller, RN, Clinical Research Associate at (312) 926-1365 or e-mail
amiller@northwestern.edu or Heather Kleinschmit, RN at (312) 926-9413 or e-mail h-kleinschmit@northwestern.edu |
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| Name of Research Trial: | Techniques for QT Measurement During Atrial Fibrillation |
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| Principal Investigator: | Alan H. Kadish, MD |
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| IRB Project Number: | 278-025 |
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Description of Research Trial:
| This research study is looking for patients who have been diagnosed with atrial fibrillation and currently have a permanent pacemaker or implanted cardioverter defibrillator in place and have been prescribed to receive the medication called Tikosyn to treat atrial fibrillation. The purpose of this study is to determine the most accurate way to measure an ECG (electrocardiogram) during Tikosyn therapy in atrial fibrillation. Participation in this study will involve being admitted to Northwestern Memorial Hospital for 3 days and possibly one six hour outpatient visit. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Amy Miller, RN, Clinical Research Associate at (312) 926-1365 or e-mail
amiller@northwestern.edu |
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