Current Studies

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ADAPT
Title: ADAPT-A Patient Registry of the Real-world Use of Orenitram®
Primary Objective: To observe and assess the real-world use and tolerability of Orenitram in new starts and rostacyclin transition patients.
Sponsor: United Therapeutics Corporation
Primary Investigator: Ronald Zolty, MD, PhD
Clinical Trials Website: NCT03045029

 

ALL IN
Title:
Targeting Inflammation and Alloimmunity in Heart Transplant Recipients with Tocilizumab
Primary Objective:
 To see if a study drug called Tocilizumab will, when given with standard anti-rejection medicines, lead to better heart transplantation outcomes at 1 year after the transplant. Specifically, the investigators will evaluate whether taking tocilizumab leads to less rejection, less development of unwanted antibodies, and better heart function.
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID) and Pharmaceutical Product Development, LLC (PPD)
Primary Investigator:
Brian Lowes, MD, PhD
Clinical Trials Website:
NCT03644667

 

AMPLATZER PFO
Title:
OSB Lead-AMPLATZER PFO Occluder New Enrollment PAS
Primary Objective:
To confirm the safety and effectiveness of the AMPLATZER™ PFO Occluder in the post Approval Setting.
Sponsor:
Abbott Medical Devices
Primary Investigator:
Jeffrey W. Delaney, MD
Clinical Trials Website:
NCT03309332

 

APPRAISE
Title:
Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP (APPRAISE ATP)
Primary Objective:
To understand the role of antitachycardia pacing (ATP) in primary prevention patients indicated for ICD therapy and programmed according to current guidance of higher rate cut-offs and therapy delays. The time to first all-cause shock will be tested in subjects with standard therapy (ATP and shocks) compared to subjects programmed to shock only to assess equivalency.
Sponsor:
Boston Scientific Corporation
Primary Investigator:
Shane Tsai, MD
Clinical Trials Website:
NCT02923726

 

ASAP-TOO
Title: Assessment of the Watchman™ Device in Patients Unsuitable for Oral Anticoagulation
Primary Objective: 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.
Sponsor: Boston Scientific Corporation
Primary Investigator: Andrew Goldsweig, MD
Clinical Trials Website: NCT02928497

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BEST CLI 
Title: Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia
Primary Objective: To evaluate the safety and effectiveness of best endovascular (EVT) versus best open surgery (OPEN) therapy in subjects with critical limb ischemia (CLI). Best revascularization, whether EVT or OPEN, is defined as the technique thought most appropriate for the patient by the operator with respect to the index limb.
Sponsor: HealthCore-NERI
Primary Investigator: G. Matthew Longo, MD, FACS
Clinical Trials Website: NCT02060630

 

BEST CLI Registry
Title: BEST Critical Limb Ischemia (vCLI) Registry
Primary Objective: To be a prospective multicenter registry evaluating the real world therapeutic strategies, clinical outcomes, and costs associated with patients presenting with critical limb ischemia.
Sponsor: Duke University and National Heart, Lung, and Blood Institute (NHLBI)
Primary Investigator: G. Matthew Longo, MD, FACS
Clinical Trials Website: NCT04191746

 

BEST TIDE
Title: The Impact of Diabetes on REvascularization
Primary Objective: To learn about the factors, like diabetes, that may cause each therapy, open bypass surgery and endovascular treatment, to succeed or fail.  This may provide information regarding how to select the right treatment and which factors may need treatment to get the most benefit of both types of treatment.
Sponsor: Vanderbilt University Medical Center
Primary Investigator: G. Matthew Longo, MD, FACS
Clinical Trials Website: NCT03085524

 

BIOBANK
Title: Nebraska Cardiovascular BioBank and Registry (NCBR)
Primary Objective: To store biological samples and associated clinical information to be used in future un-specified research studies on cardiovascular disease.
Primary Investigator: Daniel Anderson, MD, PhD

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COMBOWIRE - IMPELLA
Title: Coronary hemodynamic changes observed during Impella CP supported high risk Percutaneous Coronary Intervention
Primary Objective: To identify the effects the Impella (abiomed) percutaneous left ventricular assist device has on coronary flow and resistance during high risk percutaneous coronary intervention (HRPCI).
Sponsor: Abiomed
Primary Investigator: David E. Barton, MD

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DCM Research Project
Title: The Dilated Cardiomyopathy Research Project
Primary Objective: To advance the understanding of the genetics of dilated cardiomyopathy (DCM) by combining clinical and genetic information from a large number of families.
Sponsor: The Ohio State University
Primary Investigator: Brian Lowes, MD, PhD
Clinical Trials Website: NCT03037632 

 

DCD - NRP
Title: Heart Transplantation Using Thoraco-abdominal Normothermic Regional Perfusion (TANRP) Donation After Circulatory Death (DCD)
Primary Objective: To evaluate the feasibility of heart transplantation using thoraco-abdominal normothermic regional perfusion (TANRP) donation after circulatory death (DCD).
Grant: Great Plains IDeA CTR Pilot Program 
Primary Investigator: Marian Urban MD, PhD
Clinical Trials Website: NCT04626284

 

DT PAS
Title: Destination Therapy Post Approval Study
Primary Objective: Medtronic is sponsoring the HeartWare™ HVAD™ Destination Therapy (DT) Post Approval Study (PAS) to further confirm safety and effectiveness of the HeartWare Ventricular Assist Device System (HVAD System) when used as intended, in "real-world" clinical practice.
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Primary Investigator: Adam F. Burdorf, DO
Clinical Trials Website: NCT03681210

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EMPULSE
Title: A Multicentre, Randomised, Double-blind, 90-day Superiority Trial to Evaluate the Effect on Clinical Benefit, Safety and Tolerability of Once Daily Oral EMPagliflozin 10 mg Compared to Placebo, Initiated in Patients Hospitalised for acUte Heart faiLure (de Novo or Decompensated Chronic HF) Who Have Been StabilisEd.
Primary Objective: To find out whether starting to take a medicine called empagliflozin soon after first being treated in hospital helps people with acute heart failure.
Sponsor: Boehringer Ingelheim and Eli Lilly and Company
Primary Investigator: Ronald Zolty, MD, PhD
Clinical Trials Website: NCT04157751

 

EXPEDITE
Title: A 16-Week, Multicenter, Open-label Study of Remodulin Induction Followed by Orenitram Optimization in Subjects With Pulmonary Arterial Hypertension
Primary Objective: To evaluate the dose of Orenitram® (treprostinil) Extended Release Tablets achieved at 16 weeks after a short-term course of Remodulin® (treprostinil) Injection in subjects with pulmonary arterial hypertension (PAH).
Sponsor: United Therapeutics
Primary Investigator: Ronald Zolty, MD, PhD
Clinical Trials Website: NCT03497689

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GALACTIC
Title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects with Chronic Heart Failure with Reduced Ejection Fraction
Primary Objective: To evaluate the effect of treatment with omecamtiv mecarbil compared with
placebo, on the time to cardiovascular death or first heart failure event,whichever occurs first, in subjects with chronic heart failure with reduced ejection fraction receiving standard of care therapy.
Sponsor: Amgen, Inc.
Primary Investigator: Ronald Zolty, MD, PhD
Clinical Trials Website: NCT02929329

 

GREAT
Title: 'GREAT' Global Registry for Endovascular Aortic Treatment - Outcomes Evaluation
Primary Objective: To create a prospective observational cohort Registry designed to obtain data on device performance and clinical outcomes of patients treated with Gore Endovascular Aortic products.
Sponsor: W.L.Gore & Associates
Primary Investigator: G. Matthew Longo, MD, FACS
Clinical Trials Website: NCT01658787

 

GUIDE - HF
Title: Hemodynamic-GUIDEd Management of Heart Failure
Primary Objective: 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.
Sponsor: Abbott Medical Devices
Primary Investigator: Adam Burdorf, DO
Clinical Trials Website:
 NCT03387813

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HEARTBiT
Title: HEARTBiT: A Multi-Marker Blood Test for Acute Cardiac Transplant Rejection
Primary Objective: To develop a new blood test to monitor heart transplant rejection.
Sponsor: Canadian Institute of Health Research
Primary Investigator: Marshall Hyden, MD
Clinical Trials Website:
NCT03575910

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INTELLECT 2
Title: Investigation to Optimize Hemodynamic Management of HeartMate II™ Left Ventricular Assist Device Patients Using the CardioMEMS™ Pulmonary Artery Pressure Sensor in Advanced Heart Failure
Primary Objective: To characterize hemodynamic-guided management of patients with an existing left ventricular assist device (LVAD) to protocol specified target ranges and its impact on functional status, quality of life, and readmissions.
Sponsor: Abbott Medical Devices
Primary Investigator: Adam Burdorf, DO
Clinical Trials Website: NCT03247829

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LEVOSIMENDAN 05
Title: Open-Label Rollover Study of Levosimendan in Patients With Pulmonary Hypertension With Heart Failure and Preserved Left Ventricular Ejection Fraction (PH-HFpEF)
Primary Objective: To continue treatment levosimendan in patients who were participating in a Tenax sponsored study after completion of the parent study.
Sponsor: Tenax Therapeutics, Inc.
Primary Investigator: Ronald Zolty, MD, PhD
Clinical Trials Website: NCT03624010

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METEORIC - HF
Title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Effect of Omecamtiv Mecarbil on Exercise Capacity in Subjects With Heart Failure With Reduced Ejection Fraction and Decreased Exercise Tolerance
Primary Objective: To Assess the Effect of Omecamtiv Mecarbil on Exercise Capacity in Subjects With Heart Failure With Reduced Ejection Fraction and Decreased Exercise Tolerance.
Sponsor: Amgen, Cytokinetics and Servier
Primary Investigator: Ronald Zolty, MD, PhD
Clinical Trials Website: NCT03759392

 

MINT
Title: Myocardial Ischemia and Transfusion (MINT)
Primary Objective: To compare two red blood cell transfusion strategies (liberal and restrictive) for patients who have had an acute myocardial infarction and are anemic. 
Sponsor: Rutgers, The State University of New Jersey 
Primary Investigator: Andrew Goldsweig, MD
Clinical Trials Website: NCT02981407

 

MOMENTUM CAP
Title: MOMENTUM 3 CAP Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ Continued Access Protocol
Primary Objective: To evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.
Sponsor: Abbott Medical Devices in Collaboration with Thoratec, LLC
Primary Investigator: John Um, MD
Clinical Trials Website: NCT02892955

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NCSI
Title: National Cardiogenic Shock Initiative
Primary Objective: To evaluate the use of early mechanical circulatory support in patients presenting with acute myocardial infarction and cardiogenic shock. Patients are treated according to the National Cardiogenic Shock Initiative protocol, which emphasizes early identification of cardiogenic shock and rapid delivery of mechanical circulatory support based on invasive hemodynamics.
Sponsor: Henry Ford Health System in collaboration with Abiomed Inc. and Chiesi Farmaceutici S.PA
Primary Investigator: Andrew Goldsweig, MD
Clinical Trials Website: NCT03677180

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OCS DCD Heart CAP
Title: The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts from Donors after Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)
Primary Objective: To enable continued clinical access to DCD heart transplantation in the U.S. and to continue to collect additional data on the performance of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.
Sponsor: TransMedics
Primary Investigator: John Um, MD
Clinical Trials Website: NCT04615182

 

OCS TOP Registry
Title: The Organ Care System (OCS™) Lung Thoracic Organ Perfusion (TOP) Registry for Donor Lungs for Transplantation
Primary Objective: To evaluate short and long-term safety and effectiveness of the OCS™ Lung System for lung transplantation in a real-world environment and will provide the data for two post-approval studies.
Sponsor: TransMedics
Primary Investigator: Aleem Siddique, MBBS, FACS
Clinical Trials Website: NCT03639025

 

OPTIMIZE PRO
Title: Optimize PRO Transcatheter Aortic Valve Replacement Post Market Study
Primary Objective: To collect clinical evidence on valve performance and procedural outcomes associated with an "optimized" TAVR care pathway and using the Evolut™ PRO and Evolut™ PRO+ device.
Sponsor: Medtronic Cardiovascular
Primary Investigator: Andrew Goldsweig, MD
Clinical Trials Website: NCT04091048

 

ONYX
Title: A post-approval study of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
(RESOLUTE ONYX Post-Approval Study)
Primary Objective: To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population.
Sponsor: Medtronic
Primary Investigator: Yiannis S. Chatzizisis, MD, PhD
Clinical Trials Website: NCT03063749

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PARAGLIDE
Title: A Multicenter, Randomized, Double-blind, Double-dummy, Parallel Group, Active Controlled Study to Evaluate the Effect of Sacubitril/Valsartan (LCZ696) Versus Valsartan on Changes in NT-proBNP and Outcomes, Safety, and Tolerability in HFpEF Patients With Acute Decompensated Heart Failure (ADHF) Who Have Been Stabilized During Hospitalization and Initiated In-hospital or Within 30 Days Post-discharge
Primary Objective: To assess the effect of sacubitril/valsartan (LCZ696) vs. valsartan on changes in NT-proBNP and outcomes, safety and tolerability in patients with HFpEF (left ventricular ejection fraction (LVEF) > 40%) who have been stabilized during hospitalization for acute decompensated heart failure and initiated in-hospital or within 30 days post discharge.
Sponsor: Novartis Pharmaceuticals
Primary Investigator: Ronald Zolty, MD, PhD
Clinical Trials Website: NCT03988634

 

PATISIRAN
Title: A Phase 4 Multicenter Observational Study to Evaluate the Effectiveness of Patisiran in Patients With Polyneuropathy of Hereditary Transthyretin-Mediated (ATTRv) Amyloidosis With a V122I or T60A Mutation
Primary Objective: To evaluate the effectiveness of patisiran in patients with ATTRv amyloidosis with polyneuropathy who have a V122I or T60A mutation.
Sponsor: Alnylam Pharmaceuticals
Primary Investigator: Ronald Zolty, MD, PhD
Clinical Trials Website: NCT04201418

 

PROACT Xa
Title: A Prospective, Randomized, Active (Warfarin) Controlled, Parallel-arm Clinical Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely and Effectively on Apixaban
Primary Objective: To determine if participants with an On-X Prosthetic Heart Valve / On-X aortic valve can be maintained safely and effectively on apixaban.
Sponsor: CryoLife, Inc.
Primary Investigator: Aleem Siddique, MBBS, FACS
Clinical Trials Website: NCT04142658

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ROMA
Title: Randomized Comparison of the Clinical Outcome of Single Versus Multiple Arterial Grafts: the ROMA Trial
Primary Objective: To conduct a multicenter international randomized control trial to test the hypothesis that the use of a two or more AGs compared to a single arterial graft is associated with a reduction in the composite outcome of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization.
Sponsor: Weill Medical College of Cornell University, National Heart, Lung, and Blood Institute (NHLBI), and Canadian Institutes of Health Research (CIHR)
Primary Investigator: Aleem Siddique, MBBS, FACS
Clinical Trials Website: NCT03217006

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SAFE STEMI
Title: Study of Access Site for Enhancing PCI in STEMI for Seniors (SAFE STEMI for Seniors)
Primary Objective: To simultaneously address four potential advances in ST-Elevation Myocardial Infarction (STEMI) care for patients at least 65 years old. The investigators are looking to see if these advances can improve the outcome for these patients.

  1. Opening the arteries with a Medtronic stent
  2. Radial access (from wrist) success with a Medtronic stent
  3. Checking the percent of blockage in the diseased artery/arteries using Volcano guide wires.
  4. Reduced bleeding and vascular complications with radial arterial access for primary PCI in STEMI.

Sponsor: David Kong, MD 
Primary Investigator: Yiannis S. Chatzizisis, MD, PhD
Clinical Trials Website: NCT02939976

 

SFA Stent
Title: Optimal Stent Selection for the Femoropopliteal Artery
Primary Objective: To determine the effects of Peripheral Artery Disease (PAD) stenting on the femoropopliteal artery.
Sponsor: University of Nebraska
Primary Investigator: Jason MacTaggart, MD, FACS
Clinical Trials Website: NCT02602145

 

SHORE
Title: Surveillance HeartCare Outcomes Registry (SHORE)
Primary Objective: To assess the clinical utility of surveillance using HeartCare testing services, in association with clinical care of heart transplant recipients.
Sponsor: CareDx
Primary Investigator: Brian Lowes, MD, PhD
Clinical Trials Website: NCT03695601

 

SWIFT
Title: Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy
Primary Objective: To evaluate the implantation of the HM3 utilizing techniques other than full median sternotomy (e.g. thoracotomy) and impact on post-implant length of stay.
Sponsor: Abbott Medical Devices
Primary Investigator: John Um, MD
Clinical Trials Website: NCT04548128

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TAVR UNLOAD
Title: Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure: A Randomized Trial (TAVR UNLOAD)
Primary Objective: 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.
Sponsor: Cardiovascular Research Foundation in collaboration with Boston Biomedical Associates
Primary Investigator: Andrew Goldsweig, MD
Clinical Trials Website: NCT02661451

 

TRANSCEND
Title: The Randomized And Controlled Noninferiority Trial to Evaluate Safety and Clinical Efficacy of the SurVeil™ Drug-Coated Balloon iN the Treatment of Subjects with Stenotic Lesions of the Femoropopliteal Artery Compared to the Medtronic IN.PACT® Admiral® Drug-Coated Balloon
Primary Objective: To demonstrate the safety and efficacy of the SurVeil DCB for treatment of
subjects with symptomatic peripheral artery disease (PAD) due to stenosis of the femoral and/or popliteal arteries.
Sponsor: Surmodics, Inc.
Primary Investigator: Andrew Goldsweig, MD
Clinical Trials Website: NCT03241459

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