To find the appropriate clinical trial, select a diagnosis from the list:
Mitral Regurgitation
Acute Myocardial Infarction
Aortic Stenosis
Atrial Fibrillation
Carotid Artery Disease
Coronary Artery Disease
Stroke or TIA of Unknow Origin and PFO 


Diagnosis: Mitral Regurgitation (MR)

Eligibility criteria: 

  1. Non-High Risk:
    • Moderate to Severe MR (3) or Severe MR (4)
    • Ejection Fracture greater than or equal to 25%
    • Age 18 or older
    • Candidate for mitral repair or replacement surgery
    • Echo qualifying cardiac anatomy
  2. High Risk
    • Moderate to Severe MR (3) or Severe MR (4)
    • High risk surgical candidate based on STS score ≥ 12% or cardiac surgeon ‘s judgment
    • Echo qualifying cardiac anatomy

Study Name and Description: 
Everest II  Real World ExpAnded MuLtIcenter Study of the MitraClip® System (REALISM)
This study is looking for participants who have mitral regurgitation classified as moderate to severe (3) or severe (4) MR. Mitral regurgitation is the result of mitral valve degeneration due to age or disease. There are a number of treatment options, however, mitral valve repair has consistently demonstrated improved short and long-term outcomes.    REALISM, this registry trial, will collect safety and effectiveness information about the “real world” implantation of the MitraClip® System. The MitraClip® system repairs mitral regurgitation using a percutaneous approach. The clip is attached to a delivery system that advances the clip via the femoral vein across the septum between the right and left atrial heart chambers to position the clip to repair the leaking mitral valve. This procedure is done in a cardiac catheterization laboratory.

There are 2 arms of the study one for high risk surgical patients, people who are told they would not survive the surgical procedure, and one for non-high risk patients who qualify for mitral repair or replacement surgery. The study  has baseline, procedure and discharge visits  and then follow-up visits post-procedure at 30 days, 6 months, 12 months, and thereafter yearly for 5 years. Echocardiograms and brief physicals are the common procedures performed at the visits. There is also a functional capacity sub-study for qualified non-high risk patients where a 6 minute walk is performed.

Articles:Feldman T, Leon M. Prospects for percutaneous valve therapies. Circulation 2007; 116: 2866-2877
Feldman T. Percutaneous mitral valve repair. Interventional Cardiology 2007; 20-6: 488-494
Investigator: Ted Feldman, MD
Sponsor: Evalve Inc.
Contact:  Claudia Focks, RN, MS, CCRC. 847.570.2366 or email CFocks@northshore.org;


 Diagnosis: Acute Myocardial Infarction

Eligibility Criteria:
You may be eligible for participation in a study if you:

  • Are hospitalized with Acute Myocardial Infarction
  • Are age 18 -55
  • Have EKG changes indicative of new ischemia and a positive troponin lab result 

Study Name and Description:
VIRGO – Variation in Recovery:  Role of Gender on Outcomes of Young Acute Myocardial Infarction Patients This study is being offered to patients with Acute Myocardial Infraction.
The purpose of this study is to determine:

  • Sex differences in outcomes following Acute Myocardial Infarction
  • Sex differences in the prevalence and prognostic importance of demo graph, clinical and psychosocial risk factors
  • Sex differences in quality of care
  • Sex differences in the prevalence and prognostic importance of selected biochemical biomarkers following Acute Myocardial Infarction

The investigator will be working closely with the American Heart Association to disseminate study findings through various channels including the American Heart Association,  American College of Cardiology, National Heart Lung and Blood Institute, and Yale University School of Medicine.

Investigators:  Eileen Kelly, MD 
Sponsors:
National Institute of Health
Contact:  Jean Skelskey, RN  847.570.1810 , jskelskey@northshore.org  


 Diagnosis: AORTIC STENOSIS

Study Name and Description:
The PARTNER (US) Trial: Placement of AoRtic TraNscathetER Valves 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).
Participation in this study will last for a minimum of 5 years with at least 7 follow-up visits which will occur at NorthShore University HealthSystem.

Articles: 

Investigators: Ted Feldman, MD
Sponsors: Edwards Lifesciences
Contact: For more information, interested participants and clinicians may contact the NorthShore University HealthSystem research nurse, Dale Seifert, RN at (847) 570-2368 or e-mail DSeifert@northshore.org.


 Diagnosis: CAROTID ARTERY DISEASE

Eligibility Criteria: 

  • Patients with neurological symptoms and ≥ 50% stenosis of the common or internal carotid artery by ultrasound or angiogram,

                                                             OR 

  • Patients without neurological symptoms and ≥ 80% stenosis of the common or internal carotid artery by ultrasound or angiogram

Study Name and Description:
Carotid Stenting For High Surgical-Risk Patients; Evaluating Outcomes Through The Collection Of Clinical Evidence ("CHOICE") 

This study is being offered to patients who are scheduled to undergo a carotid stent procedure because they are too high risk for surgery of their carotid artery. Safety and health outcome information will be collected from patients who enroll in the study and receive the FDA approved devices. This study length is approximately 30 days.

Articles:  

  • Stenting versus Endarterectomy for Treatment of Carotid-Artery Stenosis: New England Journal of Medicine  published May 26, 2010 updated June 14, 2010 at NEJM.org: 10.1056/nejmoa0912321 nejm.org
  • Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomized controlled trial:  www.thelancet.com Published online February 26, 2010 DOI:10.1016/S0140-6736(10)60239-5

Investigators: Ted Feldman, MD; NavYesh Gupta, MD; Michael Salinger, MD; Tina Desai, MD; Justin Levisay, MD
Sponsor: Abbott Vascular
Contact: Claudia Focks, RN, MS, CCRC. 847.570.2366 or email CFocks@northshore.org 

 


 Diagnosis: ATRIAL FIBRILLATION 

Eligibility Criteria:
You may be eligible for participation in a study if you:

  • Have atrial fibrillation 
  • Are required to take a blood thinning drug (Coumadin®) because of atrial fibrillation 
  • Are able to take aspirin
  • Do not have an implanted mechanical heart valve

Study Name and Description: 

                   Prospective Randomized EVAluation of the WATCHMAN

                   LAA Closure Device In Patients with Atrial Fibrillation Versus Long Term

                   Warfarin Therapy (PREVAIL)

NorthShore University HealthSystem is the only site in Illinois to offer this study to patients who have atrial fibrillation and are taking the blood thinning medication Coumadin®. The purpose of this study is to offer an alternative treatment (WATCHMAN®  device) that may replace the need for long-term use of Coumadin®. The WATCHMAN® device is permanently inserted in the left upper appendage of the heart.  Patients have a 2 out of 3 chance of being randomly assigned to having the device placed. This study will compare medical information from two groups of patients; those who receive the device and those who remain on Coumadin®.

 

Articles:  

-Initial Worldwide Experience With the WATCHMAN Left Atrial Appendage System for Stroke Prevention in Atrial Fibrillation,  Sick, Peter B.MD,et al.  Journal of the American College of Cardiology, Vol.49, No 13, 2007

 

-Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomized non- Inferiority trial. , Holmes, David R. et al,  The Lancet, Vol 374, August 15, 2009

 

-Left Atrial Appendage Occlusion Eliminates the Need for Warfarin, Holmes, Jr.,  David R. et al, Circulation,  December 3, 2009

 

-Safety of Percutaneous Left Atrial Appendage Closure: Results from the Watchman Left Atrial Appendage System for Embolic Protection in Patients with AF (PROTECT AF) Clinical Trial and the Continued Access Registry., Reddy, Vivek Y., et al,  Circulation,  January 18, 2011

 

Investigators:  Ted Feldman, MD, Westby G. Fisher, MD, Jose Nazari, MD
Sponsors: Atritech, Inc.
Contact:  Kathleen Medica, RN, MS, CCRP   847-570-1997 or email kmedica@northshore.org 


 Diagnosis: CORONARY ARTERY DISEASE

Eligibility Criteria:
You may be eligible for participation in a study if you:

  • DIABETIC and have coronary blockages in at least two heart vessels in two different areas of the heart
  • Have never had heart bypass surgery
  • Have not had any previous heart stent placed within 6 months

Study Name and Description:
The FREEDOM Trial: Future revascularization evaluation in patients with diabetes mellitus: optimal management of multivessel disease
This study will help determine the best treatment for diabetic patients with coronary artery disease in more than one of the heart vessels. Patients will be randomly assigned to receive either surgery or stenting.

Articles: 

Sponsors: National Institute of Health, conducted through the Mt. Sinai School of Medicine
Contact:   Dale Seifert, RN   847.570.2368 or email DSeifert@northshore.org 


   Diagnosis: STROKE OR TIA OF UNKNOWN ORIGIN AND PFO

Eligibility Criteria: 

  • Stroke of unknown cause or image-confirmed Transient Ischemic Attack, with a confirmed PFO
  • Age between 18 and 60
  • No evidence of a blood clot or increased tendency to clot
  • Absence of an identifiable source of blood clot
  • No autoimmune disease
  • Not on warfarin therapy

Study Name:
GORE HELEX™ Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imagining Confirmed TIA in Patients with Patent Foramen Ovale (PFO) – The GORE REDUCE Study

Description of the Research Study:
This research study is being offered to patients with a diagnosis of cryptogenic stroke or TIA who also have a PFO. The study purpose is to demonstrate that antiplatelet medical management plus PFO closure with the GORE HELEX Septal Occluder reduces the risk of a recurrent stroke or image-confirmed TIA compared to antiplatelet medical management alone. This is a randomized study where eligible participants will be assigned either to 1) the treatment of percutaneous (through a vein in the groin) PFO closure with a GORE HELEX device using cardiac catheterization plus antiplatelet therapy, or to 2) antiplatelet therapy alone.

The use of the GORE HELLEX device for this indication has not been approved by the US Food and Drug Administration (FDA) and therefore it is considered investigational.

Participation in the trial will last 5 years and include a minimum of 7 visits at NorthShore University HealthSystem.
Investigator: Ted Feldman, MD, Richard Munson, MD
Sponsor: W.L. Gore &Associates, Inc.
Contact: Claudia Focks, RN, MS, CCRC 847-570-2366 or email cfocks@northshore.org 


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