TAILOR-PCI | Parachute IV | COAPT | REPRISE | STRENGTHANCHOR | ACCELERATE | TAVR | PARTNER II | Mitral | Tendyne | Silver AMI

Tailored Antiplatelet Initiation to Lessen Outcomes due to Decreased Clopidogrel Response after Percutaneous Coronary Intervention (TAILOR-PCI)
Aims: This study is looking for participants who underwent a Percutaneous coronary intervention (PCI) procedure initially presenting with either acute coronary syndrome or stable coronary artery disease. The patients will be randomized to one of two groups (with 50:50 chance): the conventional therapy group in which the patients will receive clopidogrel (Plavix) once daily with retrospective genotype analysis performed at the end of one year of treatment; and the prospective genotyping group, in which the patients will have prospective genotyping performed (via a buccal swab) to guide anti-platelet therapy.  Patients in this group who are identified to have reduced function CYP2C19 allele will receive ticagrelor (Brilinta) twice daily and patients with wild type CYP2C19 allele will receive clopidogrel (Plavix) once daily. The participants from both groups will have their genotype tested after one year from a stored blood sample drawn while at the hospital.
The purpose of this study is by using pharmacogenomics (perspective and retrospective genotyping) to determine whether choosing medication (antiplatelet therapy) based on an individual genotype will lead to better outcomes defined as a decrease in major cardiac events in patients undergoing PCI.
Participation in the study will last for 12 months with 3 follow up phone visits. The study is expected to be completed in 2016.
Diagnosis: Percutaneous coronary intervention (PCI) procedure
Principal Investigator/s: Jorge Saucedo, MD (NorthShore University HealthSytem); Naveen Pereira, MD (Mayo Clinic)
IRB Approval Number: EH13-405
Sponsor: Mayo Clinic; Spartan Bioscience, Inc. is providing lab equipment for use in this study
Contact: Dana Melgar at 847.251.4821
Open to Enrollment: Yes 

Parachute IV - PercutAneous Ventricular RestorAtion in Chronic Heart FailUre due to Ischemic HearT DiseasE
Aims: This study is looking for participants who have developed heart failure after a heart attack. The purpose of this study is to evaluate the safety and effectiveness of the Parachute device for the treatment of heart failure due to a previous heart attack. This is a randomized study (50:50) between receiving the device and medical therapy. The Parachute device is implanted in the left  ventricle excluding the non-functional heart segment from the healthy functional segment. This is intended to restore the shape and function of the heart allowing the healthy heart tissue to work more efficiently during each heart beat.
Diagnosis: Heart failure which develops following a heart attack
Principal Investigators: Ted Feldman, MD, and Steven Smart, MD
IRB Approval Number: EH14-046
Sponsor: CardioKinetix, Inc
Contact: Lisa Smalley, RN, at 847.570.2366 or lsmalley@northshore.org
Open to Enrollment: Yes

COAPT - Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation
Aims: This study is looking for participants with leakage of the mitral heart valve due to abnormal valve closure (FMR). The purpose of the study is to compare the performance of the Mitra Clip system plus optimal medical therapy with optimal medical therapy alone. This study is a randomized study (50:50) between receiving the device plus medical therapy and medical therapy.
Diagnosis: Functional Mitral regurgitation with symptomatic Heart failure
Principal Investigator: Ted Feldman, MD
IRB Approval Number: EH12-228
Sponsor: Evalve, Inc, a subsidiary of Abbott Vascular, Inc.
Contact: Lisa Smalley, RN, at 847.570.2366 or lsmalley@northshore.org
Open to Enrollment: Yes

REPRISE III: Repositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of LotusValve System – Randomized Clinical Evaluation
Aims: Patients that are at high to extreme high risk for standard surgical aortic valve replacement have this opportunity for a less invasive delivery of a new research valve. This is called a TAVR procedure – transcatheter aortic valve replacement. These valves are placed through the femoral artery using conventional catheter techniques.There are commercial TAVR procedures using FDA approved valves. However, with this study we are introducing a new research valve, the Lotus™ Valve. We aim to evaluate the safety and effectiveness of the Lotus™ Valve System compared to the commercially availableCoreValve®. This is a randomized study 2:3 ratio.
Diagnosis: Symptomatic Severe, Calcific Aortic Valve Stenosis
Principal Site and National Co-Principal Investigator: Ted Feldman, MD
IRB Approval Number: EH14-322
Sponsor: Boston Scientific Corporation
Contact: Dale Seifert, RN, at 847.570.2368 or dseifert@northshore.org
Open to Enrollment: Yes

STRENGTH: A Long-Term Outcomes Study to Assess Statin Residual Risk Reduction with EpaNova in High Cardiovascular Risk Patients with Hypertriglyceridemia
Aims: The STRENGTH Trial is a Phase III, multicenter, randomized, placebo-controlled (corn-oil), double-blind study to evaluate the effectiveness of adding omega-3 carboxylic acids (Epanova®) to statin therapy (with or without ezetimibe) for reducing major adverse CV events (MACE)* in adults with persistent hypertriglyceridemia. The time to first occurrence of MACE is the primary outcome measure for the STRENGTH Trial and the time to reach the required number of MACE events will determine the length of the study, which is anticipated to be 3–5 years.
Diagnosis:  Persistent hypertriglyceridemia on maximum tolerated statin dose
Principal Investigator/s: Jorge Saucedo, MD; David J. Davidson, MD
IRB Approval Number: EH14-141
Sponsor: AstraZeneca
Contact: Dana Melgar, RN at 847.570.2069, Evanston Hospital;  224.251.4821, Skokie Hospital or dmelgar@northshore.org
Open to Enrollment: Yes 

ANCHOR - Aneurysm Treatment using the HeliFX Aortic Securement System Global Registry
Aims: Endografts are often employed in the treatment of Abdmoinal Aortic Aneurysms. The Aptus HeliFX Aortic Securement System allow the surgeon to use EndoAnchors, similar to small screws, to secure the endograft to the wall of the aorta, providing additional fixation and sealing of the endograft in place. The system can be used in either: 

  • Patients who already have an endograft (previously placed) that the surgeon thinks will benefit from additional securing
  • Patients who are undergoing placement of an initial endogrqaft repair, particularly those whose anatomy may make securing the graft without the use of EndoAnchors difficult (the surgeon believes the endograft may be at risk of not “fixing” to the wall of the aorta, or not sealing well).

This Global Registry will allow for collection of clinical data on patients who have had the EndoAnchors placed in their endograft and to expand the knowledge of how well the system is working over a broad spectrum of geographies and a variety of practicing clinicians.

Diagnosis: Abdominal aortic aneurysm (AA); Endoleak
Principal Investigator: NavYash Gupta, MD
IRB Approval Number: EH12-461
Sponsor: Aptus Endosystems, Inc.
Contact: Karen Hynes at 847.663.8017 or khynes@northshore.org
Open to Enrollment: Yes

The ACCELERATE Study: Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition with Evacetrapib in Patients at a High Risk for Vascular Outcomes
Aims: The purpose of this study is to see how safe the investigational drug (evacetrapib, not FDA-approved) is and how well it will work to help people who have been diagnosed with high risk vascular disease. A small sample of participant’s blood is collected for future genomic research regarding high risk vascular disease.
Diagnosis:  Patients with high risk vascular disease (blockages in the blood vessels to their heart, brain, or legs who are at high risk for having a heart attack, stroke or may even die from the disease).
Principal Investigator: Brian Shortal, MD
IRB Approval Number: EH12-419
Sponsor: Eli Lilly and Company
Contact: Elena Genova, Ph.D., CCRP, at 847.444.5314 or egenova-peeva@northshore.org
Open to Enrollment: No

Transcaval Access for transcatheter aortic valve replacement in patients with no good options for aortic access.  
Aims: Patients who require the TAVR (transcatheter aortic valve replacement) procedure but whose doctors believe they cannot be treated by other anatomical approaches (through the leg, side of the chest or front of the chest), will have the opportunity to participate in this research study. This study is a registry which means patients who meet eligibility criteria are enrolled. They will receive the valve with the transcaval approach (through their femoral vein, accessing their inferior vena cava (IVC)  and their abdominal aorta).  An occluder (Amplatzer manufactured by St. Jude) will be used to close off the access sites in the IVC and aorta. The purpose of this study is to evaluate the safety and effectiveness of the IVC/aortic access and use of the occluder in patients who are not good candidates for conventional approaches for the TAVR procedure. Follow up will take place at 30 days, 6 and 12 months.
Diagnosis: Severe Aortic Valve Stenosis
Principal Investigator: Ted E. Feldman, MD
IRB Approval Number: EH 15-005
Sponsor:  Dr. Robert J. Lederman at the National Heart Lung and Blood Institute, National Institutes of Health.
Contact: Lisa Smalley, RN at 847.570.2366
Open to Enrollment: Yes

PARTNER II Trial for SAPIEN 3 Intermediate Continued Access. The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve with Associated Delivery Systems in Intermediate Patients with Severe Symptomatic Aortic Stenosis
Aims: Patients who are deemed to be intermediate risk for standard surgical aortic valve replacement have the opportunity to  participate in this research trial which involves insertion of the aortic valve with the THV (Transcatheter Heart Valve) procedure. This study is a registry which means patients who meet eligibility criteria are enrolled and will receive the valve through one of three approaches; transfemoral (through the leg) transapical (through the side of the chest) or transaortic (through the front of the chest). The main purpose of this study is to evaluate the safety and effectiveness of the Edwards SAPIEN 3Transcatheter Heart Valve Model 9600TFX and associated delivery systems. Follow up is at 30 days and one year post procedure. Telephone contact may continue yearly through year five.
Diagnosis: Severe Aortic Valve Stenosis
Principal Investigator: Ted E. Feldman, MD
IRB Approval Number: EH 12-182
Sponsor:  Edwards Lifesciences, LLC
Contact: Lisa Smalley, RN, at 847.570.2366 or lsmalley@northshore.org
Open to Enrollment:  Yes

The MITRAL Trial: Mitral Implantation of Transcatheter vaLves
Aims:The purpose of this research study is to evaluate if it is safe to treat patients with severe narrowing of the mitral valve or malfunction of a surgical ring previously placed in the mitral valve with the Edwards SAPIEN XT™ Transcatheter Heart Valve (THV) Model 9300 TFX and associated delivery systems: NovaFlex (transfemoral access-through the leg) and Ascendra (transapical access-through the side of the chest) or SAPIEN 3 TMModel 9600 TFX with Commander delivery system. The Edwards SAPIEN XT™ and SAPIEN 3TMstudy devices are devices designed to replace a defective aortic heart valve. They are artificial devices made to replace the aortic valve using catheters instead of standard open heart surgery.
Diagnosis:  Symptomatic severe calcific mitral valve disease with severe mitral annular calcification who are not candidates for mitral valve
Principal Investigator: Ted Feldman, MD
IRB Approval Number: EH15-136
Sponsor: Mayra Guerrero, MD
Contact: Interested patients should contact research nurse Mary Gegenhuber, RN at 847.570.1050
Open to Enrollment: Yes

Early Feasibility Study of Tendyne Bioprosthetic Mitral Valve System
Aims: The purpose of this research study is to provide early information on an investigational device called the Tendyne Bioprosthetic Mitral Valve System. The device that is being tested is considered investigational (not approved for general use) by the Food and Drug Administration (FDA). This study will collect information on how safe and effective this device is in humans to treat a leaking mitral valve in a small number of patients.  This study will also provide information that may help make this device more widely available to other people with mitral valve disease.
Diagnosis: Mitral Regurgitation
Principal Investigator: Mayra Guerrero, MD
IRB Approval Number: EH15-274
Sponsor: Tendyne Holdings, Inc.
Contact: Interested patients should contact research nurse Mary Gegenhuber, RN at 847.570.1050
Open to Enrollment:  Yes

SILVER AMI: Risk Stratification in Older Persons with AMI Multi-center, observational study
Aims:

  1. 1. To identify risk factors for all-cause hospital readmission, mortality and decline in health status following hospitalization for AMI among older persons
  2. 2. To develop and validate risk stratification tools for hospital readmission, mortality and decline in health status following hospitalization for AMI among older persons

Diagnosis: Myocardial Infarction (Heart attack)
Principal Investigator: Eileen Kelly
IRB Approval Number: EH 13-103
Sponsor: Yale University
Contact: Jean Skelskey, RN at 847.570.1810 or jskelskey@northshore.org
Open to enrollment: Yes