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Cardiology Clinical Trials

REPRISE IV | Carillon | Early TAVR | Partner 3 AVinV | Partner 3 Mitral VinV | TAVR UNLOAD  | ASAP-TOO | REDUCELAP –HF II | BeAT-HF | EMBRACE_HF | PRESERVED_HF  | VISITAG SURPOINT  | PREEMPT HF | GUIDE-HF | IVAS NUPULSE | ECG Belt |


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

Aims:To evaluate 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: 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 Aortic Valve in Valve 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 the 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: Justin Levisay, MD 
IRB Approval Number: EH17-095
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 Valve in Valve Trial: 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:  The purpose of this study is 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; who are at intermediate risk for standard mitral valve in valve replacement.
Principal Investigator/s: Justin Levisay, 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: ranscatheter 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 anticoagulation 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:  Jose Nazari,  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 Randomized Trial II: A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure

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 Linda Pierchala at 847.570.1997 or email lpierchala@northshore.org;
Open to Enrollment: Yes


BeAT-HF: BAROSTIM NEO - Baroreflex Activation 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 email stheegala@northshore.org
Open to Enrollment:  Yes


EMBRACE-HF: Empagliflozin Impact on Hemodynamics in Patients with Heart Failure (EMBRACE-HF).

Aims: The primary purpose of this trial is to evaluate the impact of empagliflozin, as compared with placebo, on hemodynamic parameters (pulmonary artery diastolic pressure) in patients with heart failure (reduced or preserved ejection fraction, ischemic or non-ischemic etiology) who already have a CardioMEMs device implanted for non-study related clinical reasons.
Diagnosis: Heart failure
Principal Investigator: Robert Gordon, MD
IRB Approval Number: EH18-171
Sponsor:  Saint Luke's Health System
Contact:  Interested patients may contact Saritha Theegala at 847.570.2912 or email stheegala@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: 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


VISITAG: Evaluation of the VISITAG SURPOINT™ Module With External Processing Unit (EPU) When Used With the THERMOCOOL SMARTTOUCH® SF and the THERMOCOOL SMARTTOUCH® Catheters for Pulmonary Vein Isolation (PVI) (SURPOINT COA)

Aims: Prospective, non-randomized, post-market clinical evaluation of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with STSF catheter and ST catheter compared to a historical control performance goal.
Diagnosis: Paroxysmal Atrial Fibrillation
Principal Investigator: Mark Metzl, MD
IRB Approval Number: EH19-052
Sponsor:  Biosense Webster, Inc.
Contact:  Interested patients may contact Linda Pierchala at 847.570.1997 or email lpierchala@Northshore.org
Open to Enrollment: Yes


PREEMPT-HF: Precision Event Monitoring for Patients With Heart Failure Using HeartLogic™

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, Defibrillators, CRT
Principal Investigator: Mark Metzl, MD
IRB Approval Number: EH19-118
Sponsor: Boston Scientific
Contact: Interested patients may contact Anat Sharon at 847.570.3861 or email: asharon@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: Robert Gordon, MD
IRB Approval Number: EH19-157
Sponsor: Abbott Medical Devices
Contact: Interested patients may contact Laurene Sherman at 847.570.3083 or email: lsherman2@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, NYHA III and IV
Principal Investigator: Robert Gordon, MD; 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: 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