ACURATE IDE | AGENT IDE | ALLEVIATE-HF | EMPOWER | ENCIRCLE | FACT-CRT | OMNY-AF | PROTECT IV | REACT-AF | REAL-AF | REALIZE K | RESPONDER-HF | SMART | SOS-AMI | STEMI-DTU | TRILUMINATE | TAVR UNLOAD | Victorian-PLAQUE |
ACURATE IDE: Transcatheter Replacement of Stenotic Aortic Valve through Implantation of ACURATE in Subjects InDicatEd for TAVR
Aims: To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.
Diagnosis: Severe Aortic Stenosis
Principal Investigator/s: Justin Levisay, MD
IRB Approval Number: EH21-126
Sponsor: Boston Scientific Corporation
Contact: Interested patients may contact John Daseke at 847.570.2253 or email mdaseke@Northshore.org
Open to Enrollment: Yes
AGENT IDE: A Prospective, Randomized (2:1), Multicenter Trial to Assess the Safety and Effectiveness of the Agent™ Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects with In-Stent Restenosis (ISR)
Aims: This is a prospective, randomized, trial to assess the safety and effectiveness of the Agent™ Paclitaxel Coated PTCA Balloon Catheter compared to balloon angioplasty (POBA) in patients with in-stent restenosis.
Diagnosis: In-Stent Restenosis
Principal Investigator/s: Justin Levisay, MD
IRB Approval Number: EH21-265
Sponsor: Boston Scientific
Contact: Interested patients may contact Laurene Sherman at 847.570.3083 or email lsherman2@northshore.org
Open to Enrollment: Yes
ALLEVIATE-HF: Algorithm using LINQ Sensors for Evaluation And Treatment of Heart Failure
Aims: This is a randomized, interventional and investigational device exempt clinical study. All enrolled subjects will be implanted with a Reveal LINQ Insertable Cardiac Monitor (ICM) with an investigational ALLEVIATE-HF RAMware download. Subjects in the intervention arm will undergo a PRN medication intervention for acute volume. Observation arm subjects will start with an observational period of 13 months during which they will be treated per standard of care for heart failure management, and will then automatically transition to the intervention arm for the remainder of their participation in the study.
Diagnosis: Symptomatic Heart Failure
Principal Investigator/s: Mark Metzl, MD
IRB Approval Number: EH22-025
Sponsor: Medtronic, Inc.
Contact: Interested patients may contact Marisa Durante at 847.503.6454 or email mdurante@northshore.org
Open to Enrollment: Yes
EMPOWER: 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 heart failure with at least mild functional mitral regurgitation (FMR) , compared to a randomized control group, which is medically managed according to heart failure guidelines.
Diagnosis: Symptomatic heart failure patients with functional mitral regurgitation
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
ENCIRCLE: SAPIEN M3 System TransCatheter MItral Valve ReplaCement via TransseptaL AccEss
Aims: To establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation for whom commercially available surgical or transcatheter treatment options are inappropriate due to clinical, anatomic or technical considerations.
Diagnosis: Mitral Regurgitation
Principal Investigator/s: Mark Ricciardi, MD
IRB Approval Number: EH21-251
Sponsor: Edwards Lifesciences
Contact: Interested patients may contact Laurene Sherman at 847.503.6399 or email lsherman2@northshore.org
Open to Enrollment: Yes
FACT-CRT: Factors Associated with Response to Cardiac Resynchronization Therapy in Heart Failure Patients with Non-Left Bundle Branch Block (LBBB) ECG Pattern
Aims: We aim to prospectively validate previously identified predictors of echocardiography response to CRT-D in HF patients with non-LBBB, and identify novel ECG variables and echocardiography variables to predict response. We will investigate whether these variables predict clinical outcomes in this cohort. We will perform machine learning analyses to predict echocardiography response to CRT-D in HF patients with non-LBBB
Diagnosis: Heart Failure with Left Ventricular Dysfunction
Principal Investigator/s: Mark Metzl, MD
IRB Approval Number: EH22-350
Sponsor: University of Rochester Medical Center
Contact: Interested patients may contact Marisa Durante at 847.503.6454 or email mdurante@northshore.org
Open to Enrollment: Yes
OMNY-AF: Assessment of Safety & effectiveness in Treatment Management of Paroxysmal Atrial Fibrillation with the BWI Pulsed Field Ablation System with OMNYPULSETM Catheter
Aims: Prospective, single-arm, multi-center, clinical evaluation of the Biosense Webster (BWI) OMNYPULSE™ Pulsed Field Ablation (PFA) Platform to demonstrate safety and long-term effectiveness of the system for the treatment of Paroxysmal Atrial Fibrillation (PAF) comparing to corresponding performance goals.
Diagnosis: Paroxysmal Atrial Fibrillation
Principal Investigator/s: Mark Metzl, MD
IRB Approval Number: EH23-408
Sponsor: Biosense Webster, Inc.
Contact: Interested patients may contact Marisa Durante at 847.503.6454 or email mdurante@northshore.org
Open to Enrollment: Yes
PROTECT IV: Impella®-Supported PCI in High-Risk Patients with Complex Coronary Artery Disease and Reduced Left Ventricular Function
Aims: This is a prospective, multicenter, randomized two arm trial. The purpose of this Study is to assess if using the Impella® device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health after a heart procedure compared to the current standard of care.
Diagnosis: Complex Coronary Artery Disease and reduced left ventricular function
Principal Investigator/s: Mark Ricciardi, MD
IRB Approval Number: EH21-182
Sponsor: Abiomed
Contact: Interested patients may contact Laurene Sherman at 847.503.6399 or email lsherman2@northshore.org as well as Samantha Klause at 847.503.6398 or SKrause@northshore.org
Open to Enrollment: Yes
REACT-AF: The Rhythm Evaluation for AntiCoagulaTion with Continuous Monitoring of Atrial Fibrillation
Aims: To assess whether Atrial Fibrillation Sensing SmartWatch (AFSW)-guided, time-delimited DOAC therapy is non-inferior to continuous DOAC therapy for a composite endpoint that includes: (1) Ischemic stroke; (2) Systemic embolism; (3) All-cause mortality. Alongside this, to also assess whether AFSW-guided, time-delimited DOAC therapy significantly reduces major bleeding events compared to continuous DOAC therapy.
Diagnosis: Atrial Fibrillation
Principal Investigator/s: Jeremiah Wasserlauf, MD
IRB Approval Number: EH23-210
Sponsor: John Hopkins University
Contact: Interested patients may contact Marisa Durante at 847.503.6454 or email mdurante@northshore.org
Open to Enrollment: Yes
REAL-AF: Real-world Experience of Catheter Ablation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation
Aims: The primary purpose of this registry is to obtain real-world clinical experience of Paroxysmal (PAF) and Persistent (PsAF) Atrial Fibrillation ablation radiofrequency (RF) technologies. Data from the registry will be used to assess clinical outcomes, including procedural efficiency, safety, and long-term, effectiveness of catheter ablation with novel RF technologies in PAF and PsAF patients.
Diagnosis: Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation.
Principal Investigator/s: Mark Metzl, MD
IRB Approval Number: EH20-030
Sponsor: Heart Rhythm Clinical and Research Solutions, LLC
Contact: Interested patients may contact Marisa Durante at 847.503.6454 or email mdurante@northshore.org
Open to Enrollment: Yes
REALIZE K: Phase IV, Double-Blind, Placebo-Controlled, Randomized Withdrawal Trial Evaluating Sodium Zirconium Cyclosilicate (SZC) for the Management of Hyperkalaemia in Patients with Symptomatic Heart Failure with Reduced Ejection Fraction and Receiving Spironolactone
Aims: The purpose of this trial is to evaluate Sodium Zirconium Cyclosilicate (SZC) as prophylaxis for hyperkalemia in heart failure patients with reduced ejection fraction and receiving spironolactone.
Diagnosis: Heart Failure with a History of Hyperkalemia
Principal Investigator/s: Robert Gordon, MD
IRB Approval Number: EH21-123
Sponsor: AstraZeneca
Contact: Interested patients may contact Linda Pierchala at 847.570.1997 or email lpierchala@northshore.org
Open to Enrollment: Yes
RESPONDER-HF: Re-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved EF Heart Failure
Aims: The primary objective of this clinical trial is to further evaluate the clinical efficacy of the Corvia Atrial Shunt in symptomatic heart failure patients with a left ventricular ejection fraction (LVEF) ≥ 40%, and elevated left sided filling pressures despite standard GuidelineDirected Medical Therapy (GDMT); and to confirm the treatment effect observed in the responder group of the REDUCE LAP-HF Randomized Trial II.
Diagnosis: Heart Failure
Principal Investigator/s: Robert Gordon, MD
IRB Approval Number: EH22-441
Sponsor: Corvia Medical, Inc.
Contact: Interested patients may contact Linda Pierchala at 847.503.6403 or email lpierchala@northshore.org
Open to Enrollment: Yes
SMART: SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial
Aims: The purpose of this trial is to generate clinical evidence on valve safety and performance of self-expanding versus balloon-expandable TAVR in subjects with a small aortic annulus and symptomatic severe native aortic stenosis.
Diagnosis: Patients with symptomatic heart disease due to severe native calcific aortic stenosis and a small annulus appropriate for transcatheter heart valve replacement therapy
Principal Investigator/s: Mark Ricciardi, MD
IRB Approval Number: EH21-238
Sponsor: Medtronic
Contact: Interested patients may contact Laurene Sherman at 847.570.3083 or email lsherman2@northshore.org
Open to Enrollment: Yes
SOS-AMI: Selatogrel Outcome Study in suspected Acute Myocardial Infarction
Aims: The aim of this research study is to test whether a new drug (selatogrel) can treat a heart attack.
Diagnosis: Recently hospitalized and discharged with a confirmed diagnosis of symptomatic type 1 AMI (STEMI/NSTEMI).
Principal Investigator/s: Arman Qamar, MD
IRB Approval Number: EH21-188
Sponsor: Idorsia
Contact: Interested patients may contact Caitlin Nagy at 847.503.6449 or email cnagy@northshore.org
Open to Enrollment: Yes
STEMI-DTU: Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction.
Aims: The purpose of this research study is to evaluate whether using the the IMPELLA® CP System temporary circulatory assist device for 30 minutes prior to a catheterization procedure has the potential to reduce the damage to the heart caused by a heart attack, compared to the current standard of care.
Diagnosis: Acute STEMI without cardiogenic shock
Principal Investigator/s: Justin Levisay, MD
IRB Approval Number: EH19-359
Sponsor: Abiomed
Contact: Interested patients may contact Linda Pierchala at 847.503.6403 or email lpierchala@northshore.org
Open to Enrollment: Yes
TRILUMINATE: Clinical TRIal to EvaLUate Cardiovascular OutcoMes IN PAtients Treated with the Tricuspid ValvE Repair System Pivotal
Aims: This clinical trial is a prospective, randomized, controlled, multicenter study of the TriClip™ 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 John Daseke at 847.570.2253 or email mdaseke@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 Laurene Sherman at 847.570.3083 or email lsherman2@northshore.org
Open to Enrollment: Yes
Victorian-PLAQUE: Phase IIIb study evaluating the effect of inclisiran on atherosclerotic plaque progression assessed by coronary computed tomography angiography (CCTA) in participants with a diagnosis of non-obstructive coronary artery disease without previous cardiovascular events
Aims: Demonstrate the superiority of inclisiran versus placebo, administered on top of maximally tolerated statin therapy, in reducing the total coronary atheroma volume assessed by Coronary Computed Tomography Angiography (CCTA) from baseline to Month 24.
Diagnosis: Non-Obstructive Coronary Artery Disease
Principal Investigator/s: Amit Pursnani, MD
IRB Approval Number: EH22-428
Sponsor: Novartis
Contact: Interested patients may contact Caitlin Nagy at 847.503.6449 or email cnagy@northshore.org
Open to Enrollment: Yes