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Cardiology Clinical Trials

Dare 19 Trial |  TRILUMINATE |  REPRISE IV |  CARILLON |  Early TAVR Trial |  Partner 3 Mitral ViV |  TAVR UNLOAD |  ASAP-TOO |  REDUCELAP –HF II Trial |  PRESERVED-HF |  Amyloid TTR |  GUIDE-HF |  iVAS NUPULSE |  ECG Belt for CRT Response |  PREEMPT-HF |  LIB003 |  PRECISE | 


Dare 19 Trial

Aims:The objective of this international, multicenter, randomized, double-blind, placebo-controlled, phase III study is to evaluate the efficacy and safety of dapagliflozin in respiratory failure in patients with COVID-19.
Diagnosis: Patients hospitalized with COVID-19
Principal Investigator/s: Robert Gordon, MD
IRB Approval Number: EH20-186
Sponsor: Boston Scientific Corporation
Contact: 
Interested patients may contact Linda Pierchala at 847.570.1997 or email lpierchala@northshore.org 
Open to Enrollment: 
Yes


TRILUMINATE

Aims:This clinical trial is a prospective, randomized, controlled, multicenter study of the TriClipTM device in symptomatic patients with severe tricuspid regurgitation who have been determined by the site’s local heart team to be at intermediate or greater estimated risk for mortality with tricuspid valve surgery.
Diagnosis: Symptomatic with severe tricuspid regurgitation
Principal Investigator/s: Mark Ricciardi, MD
IRB Approval Number: EH20-107
Sponsor: Abbott Medial Devices
Contact: 
Interested patients may contact Lisa Smalley at 847.570.2366 or email lsmalley@northshore.org 
Open to Enrollment: 
Yes


REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects

Aims:This study evaluates the safety and effectiveness of the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Sets for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe aortic stenosis who are considered at intermediate risk for surgical valve replacement including those who have a bicuspid native valve.
Diagnosis: Severe aortic valve stenosis
Principal Investigator/s: Justin Levisay, MD
IRB Approval Number: EH19-038
Sponsor: Boston Scientific Corporation
Contact: 
Interested patients may contact Dale Seifert at 847.570.2368 or email dseifert@northshore.org
Open to Enrollment: 
Yes


CARILLON: Mitral Contour System® for Reducing Functional Mitral Regurgitation

Aims:The objective of this prospective, multi-center, randomized, double-blind trial is to assess the safety and efficacy of the CARILLON Mitral Contour System® in treating functional mitral regurgitation (FMR) associated with heart failure, compared to a randomized control group, which is medically managed according to heart failure guidelines.
Diagnosis: Moderate to severe functional mitral regurge
Principal Investigator/s: Justin Levisay, MD
IRB Approval Number: EH18-251
Sponsor: Cardiac Dimensions
Contact: 
Interested patients may contact Laurene Sherman at 847.570.3083 or email lsherman2@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/s: Justin Levisay, MD
IRB Approval Number: EH17-149
Sponsor: Edwards Lifesciences
Contact: 
Interested patients may contact Lisa Smalley at 847.570.2366 or email lsmalley@northshore.org
Open to Enrollment: 
Yes


Partner 3 Mitral ViV: Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients with a Failing Mitral Bioprosthetic Valve

Aims:To assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients with a failing mitral bioprosthetic valve.
Diagnosis: Failing bioprosthetic valve in the mitral position
Principal Investigator/s: Ted Feldman, MD
IRB Approval Number: EH18-121
Sponsor: Edwards Lifesciences
Contact: 
Interested patients may contact Laurene Sherman at 847.570.3083 or email lsherman2@northshore.org
Open to Enrollment: 
Yes


TAVR UNLOAD: Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients with ADvanced Heart Failure

Aims:The objective of this study is to determine the safety and efficacy of transcatheter aortic valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as compared with OHFT.
Diagnosis: Heart failure patients with moderate aortic valve stenosis
Principal Investigator/s: Justin Levisay, MD
IRB Approval Number: EH18-251
Sponsor: Cardiovascular Research Foundation, New York
Contact: 
Interested patients may contact Lisa Smalley at 847.570.2366 or email lsmalley@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 Dale Seifert at 847.570.2368 or email dseifert@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; 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 Linda Pierchala at 847.570.1997 or email lpierchala@northshore.org
Open to Enrollment: 
Yes


PRESERVED-HF: Dapagliflozin in Type 2 Diabetes or Pre-Diabetes, and PRESERVED Ejection Fraction Heart Failure (PRESERVED-HF)

Aims:The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared with placebo, on heart failure, disease-specific biomarkers, symptoms, health status and quality of life in patients with type 2 diabetes or prediabetes and chronic heart failure with preserved systolic function.
Diagnosis: Heart failure with preserved ejection fraction
Principal Investigator/s: Robert Gordon, MD
IRB Approval Number: EH18-172
Sponsor: Saint Luke's Health System
Contact: 
Interested patients may contact Kamila Lepkowska at 847.570.2906 or email klepkowska@northshore.org
Open to Enrollment: 
Yes


Amyloid TTR

Aims:To study the efficacy and safety of AG10 in Subjects with Transthyretin Amyloid Cardiomyopathy (ATTRIBUTE-CM)
Diagnosis: ATTR-CM with either wild-type TTR or a variant TTR genotype
Principal Investigator/s: Robert Gordon, MD
IRB Approval Number: EH19-197
Sponsor: Eidos Therapeutics
Contact: 
Interested patients may contact Linda Pierchala at 847.570.1997 or email lpierchala@northshore.org
Open to Enrollment: 
Yes


GUIDE-HF: Hemodynamic-GUIDEd Management of Heart Failure

Aims:The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for future HF events or mortality.
Diagnosis: Heart failure and NYHA III and IV
Principal Investigator/s: Robert Gordon, MD
IRB Approval Number: EH19-157
Sponsor: Abbott Medical Devices
Contact: 
Interested patients may contact Saritha Theegala at 847.570.2912 or email stheegala@northshore.org
Open to Enrollment: 
Yes


iVAS NUPULSE: Feasibility Study of the Intravascular Ventricular Assist System

Aims:The purpose of this feasibility study is to assess the preliminary safety and clinical performance of the intravascular ventricular assist system (iVAS).
Diagnosis: Heart failure and NYHA III and IV
Principal Investigator/s: Robert Gordon, MD and Hyde Russell, MD
IRB Approval Number: EH19-173
Sponsor: NuPulseCV
Contact: 
Interested patients may contact Lisa Smalley at 847.570.2366 or email lsmalley@northshore.org
Open to Enrollment: 
Yes


ECG Belt for CRT Response

Aims:The purpose of this clinical study is to compare ECG Belt Research System managed cardiac resynchronization therapy (CRT) patients and a control CRT group with respect to left ventricular (LV) remodeling.
Diagnosis: Heart failure, defibrillators, CRT
Principal Investigator/s: Mark Metzl, MD
IRB Approval Number: EH19-140
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Contact: 
Interested patients may contact Laurene Sherman at 847.570.3083 or email lsherman2@northshore.org
Open to Enrollment: 
Yes


PREEMPT-HF

Aims:The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate extended applications of the HeartLogicTM Heart Failure Diagnostic (HeartLogic) in a broad spectrum of heart failure (HF) patients with an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
Diagnosis: Heart failure
Principal Investigator/s: Mark Metzl, MD
IRB Approval Number: EH19-118
Sponsor: Boston Scientific
Contact: I
nterested patients may contact Anat Sharon at 847.570.3861 or email asharon@northshore.org
Open to Enrollment: 
Yes


LIB003

Aims:The goal of this randomized, open-label, cross-over, phase 3 study is to evaluate the efficacy and safety of LIB003 with evolocumab in homozygous familial hypercholesterolemia patients on stable lipid-lowering therapy.
Diagnosis: Homozygous familial hypercholesterolemia (HoFH)
Principal Investigator/s: David Davidson, MD
IRB Approval Number: EH19-356
Sponsor: LIB Therapeutics
Contact: 
Interested patients may contact Kamila Lepkowska at 847.570.2906 or email klepkowska@northshore.org
Open to Enrollment: Yes


PRECISE

Aims:Study 1 is a prospective, randomized trial that will compare two diagnostic evaluation and management strategies for stable, symptomatic patients with suspected coronary artery disease (CAD), assessing approximately 2,100 subjects for up to two years after enrollment for clinical outcomes, quality of life and healthcare-related utilization and costs.
Diagnosis: No diagnoses required but patient has stable symptoms that suspects coronary artery disease (CAD)
Principal Investigator/s: Amit Pursnani, MD
IRB Approval Number: EH18-346
Sponsor: HeartFlow
Contact: 
Interested patients may contact Kamila Lepkowska at 847.570.2906 or email klepkowska@northshore.org
Open to Enrollment: 
Yes