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Cardiology Clinical Trials

TAILOR-PCI | dal-GenE | ASAP-TOO | REDUCELAP –HF II | BeAT-HF | COAPT CAS | CLASP | Partner 3 | Early TAVR | Partner 3 AVinV | SAPIEN M3 | TENDYNE | STOP

TAILOR-PCI: Tailored Antiplatelet Initiation to Lessen Outcomes due to Decreased Clopidogrel Response after Percutaneous Coronary Intervention)

Aims:  This study focuses on the use of 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.

Diagnosis: Percutaneous coronary intervention (PCI) procedure
Principal Investigator/s: Justin Levisay, MD  
IRB Approval Number: EH13-405
Sponsor: Mayo Clinic; Spartan Bioscience, Inc. is providing lab equipment for use in this study
Contact: Interested patients may contact Linda Pierchala, RN at 847.570.1997 or lpierchala@northshore.org
Open to Enrollment: Yes 


dal-GenE: Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population With a Recent ACS

Aims:  A placebo-controlled, randomized, double-blind, parallel group, phase III multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. Subject enrollment may begin in the hospital and will continue following release from the hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (4-12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.

Diagnosis: Subjects with the appropriate genetic background and recently hospitalized for ACS
Principal Investigator/s: David Davidson, MD    
IRB Approval Number: EH16-085
Contact: Interested patients may contact Linda Pierchala Ph-847 570-1997 LPierchala@Northshore.org
Open to Enrollment: Yes


ASAP-TOO: Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation

Aims:  The purpose of this study is to establish the safety and effectiveness of the WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device, including the post-implant medication regimen, for subjects with non-valvular atrial fibrillation who are deemed not to be eligible for anti-coagulation therapy to reduce the risk of stroke.

Diagnosis: paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular atrial fibrillation (i.e., the subject has not been diagnosed with rheumatic mitral valvular heart disease).
Principal Investigator/s:  Ted Feldman MD 
IRB Approval Number: EH17-125
Sponsor: Boston Scientific
Contact:  Interested patients may contact Jordan Keller Ph-847 570- 3861 JKeller@northshore.org
Open to Enrollment:  Yes


REDUCELAP–HF II Trial

Aims: 
Primary Outcome Measures [Time Frame: 6 months]:

  • Cardiovascular mortality or non-fatal, ischemic stroke through 6 months; Change in baseline KCCQ at 6 months. Treatment groups will be compared over time through 6 months at a two-sided 0.05 level of significance across the composite primary endpoint using the Finkelstein-Schoenfeld approach

Secondary Outcome Measures [Time Frame: 12 months]

  • Composite of Cardiovascular mortality through 12 months and Rate of total HF admissions/healthcare facility visits for IV or intensification of oral diuresis for HF through 12 months; 3. Change in KCCQ score between baseline and 12 months.

Diagnosis: Chronic symptomatic Heart Failure (HF)
Principal Investigator/s: Robert Gordon MD    
IRB Approval Number: EH17-176
Sponsor: Corvia Medical
Contact: Interested patients may contact Jordan Keller Ph-847 570-3861 JKeller@Northshore.org
Open to Enrollment: Yes


BeAT-HF (Barostim Therapy for Heart Failure)

Aims:  The purpose of this research study is to show whether the BAROSTIM NEO® System implantable device safely and effectively works in people with heart failure. An experimental procedure and therapy, the NEO System is an investigational device designed to stimulate the body’s natural cardiovascular regulators called “baroreceptors,” which are found in the large blood vessels (carotid arteries) in the neck. Patients participating in this study will be randomized to receive the device or standard of care.

Diagnosis: Heart failure
Principal Investigator: Robert Gordon, MD
IRB Approval Number: EH16-347
Sponsor:  CVRx, Inc.
Contact:  Interested patients may contact Saritha Theegala at 847.570.2912  or stheegala@northshore.org
Open to Enrollment:  Yes


COAPT CAS Trial: Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) – Continued Access

Aims:  The COAPT CAS study is designed as a prospective, multicenter, single arm, continued access registry study. A maximum of 800 subjects (anticipated) will be registered from up to 75 sites in the United States. The enrollment will end once pre-market approval (PMA) of the proposed expanded indication of MitraClip System is obtained. Active follow-up of patients will be performed through 12 months with scheduled visits at 30 days and 12 months. The national Trans catheter Valve Therapy Registry (TVT Registry) will be used for data collection through 12 months. Annual follow-up data from 2 years through year 5 post-implant will be obtained by linkage to the Centers for Medicare and Medicaid Services (CMS) Claims database.

Diagnosis: Functional Mitral Regurgitation in Symptomatic Heart Failure Subjects
Principal Investigator/s: Ted Feldman, MD
IRB Approval Number: EH17-270
Sponsor: Evalve
Contact: Interested patients may contact Jordan Keller Ph-847 570-3861 JKeller@Northshore.org
Open to Enrollment: Yes


CLASP Trial: The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study

Aims:  The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System.

Diagnosis: Clinically significant mitral regurgitation
Principal Investigator/s: Ted Feldman, MD
IRB Approval Number: EH17-334
Sponsor: Edwards LifeSciences
Contact: Interested patients may contact Dale Seifert, dseifert@northshore.org PH: 847 570 2368
Open to Enrollment: Yes


The Partner 3 Trial: The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis.

Aims:  The Partner 3 trial is a randomized multicenter study to establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement (AVR).

Diagnosis: Severe, calcified aortic stenosis
Principal Investigator: Ted Feldman, MD and Paul Pearson, MD
IRB Approval Number: EH16-190
Sponsor:  Edwards Lifesciences
Contact:  Interested patients may contact Lisa Smalley at 847.570.2366 or lsmalley@northshore.org
Open to Enrollment:  Yes


Early TAVR Trial: Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis.

Aims:  This clinical trial is a prospective, randomized, controlled, multicenter study. Patients will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 THV or clinical surveillance. Patients will be stratified by whether or not they are able to perform a treadmill stress test. Patients who have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable.

Diagnosis: Asymptomatic, severe aortic stenosis
Principal Investigator: Ted Feldman, MD
IRB Approval Number: EH17-149
Sponsor:  Edwards Lifesciences
Contact:  Interested patients may contact Lisa Smalley at 847.570.2366 or lsmalley@northshore.org
Open to Enrollment:  Yes


Partner 3 AVinV Trial: a Prospective, Single-arm, Multicenter Clinical Trial That Will Establish the Safety and Efficacy of SAPIEN 3 THV in Patients with a Failing Aortic Bioprosthetic Valve.

Aims:  The is study of Sapien #THV implantation in patients with a failing surgical or transcatheter bioprosthetic aortic valve demonstrating stenosis or insufficiency.

Diagnosis: Failing surgical or transcatheter bioprosthetic valve in the aortic position
Principal Investigator/s: Ted Feldman MD 
IRB Approval Number:  EH17-095
Sponsor:  Edwards LifeSciences
Contact:  Interested patients may contact Lisa Smalley Ph-847 570 2366 lsmalley@northshore.org
Open to Enrollment: Yes


SAPIEN M3- Confidential

Aims:  Confidential

Diagnosis: Confidential
Principal Investigator/s: Ted Feldman, MD
IRB Approval Number: EH17-329
Sponsor: Edwards LifeSciences
Contact: Interested patients may contact Lisa Smalley 847 570 -2366 LSmalley@Northshore.org
Open to Enrollment: Yes


TENDYNE- Expanded Clinical Study of the Tendyne 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 may contact Laurene Sherman at 847.570.3083 or lsherman2@northshore.org
Open to Enrollment:  Yes (Till 6/1/2018)


STOP Persistent AF (Atrial Fibrillation)

Aims: The goal of this study is to demonstrate the safety and effectiveness of the Arctic Front Advance™ and Freezor MAX® Cardiac CryoAblation Catheters for the treatment of drug refractory recurrent symptomatic persistent atrial fibrillation.

Diagnosis: Symptomatic persistent atrial fibrillation
Principal Investigator: Jose Nazari, MD
IRB Approval Number: EH17-328
Sponsor:  Medtronic Atrial Fibrillation Solutions
Contact:  Interested patients may contact Saritha Theegala at 847.570.2912 or stheegala@northshore.org
Open to Enrollment:  Yes