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Clinical Trials

Study NamePISponsorDescriptionBegunStatus
ADC Andrew Sauer, MD Abbott A Sensor Based Monitoring System for Metabolic Signatures of Congestive Heart Failure Status, an Exploratory Study 5/28/2021 Enrolling
AHF Biorepository Nicholas Haglund, MD KUMC A comprehensive advanced heart failure registry and biorepository with patients who are seen at KUMC. The purpose of this research project is to collect, store, and dispense human samples with health information and to make them available to research investigators. The study team will provide samples to approved researchers at KUMC or to researchers outside of KUMC for future studies. 12/1/2018 Enrolling
Alt-Flow Mark Wiley, MD Edwards Lifesciences, LLC Early Feasibility Study of the Edwards Transcatheter Atrial Shunt System. A multi-center, prospective, early feasibility study. 4/29/2020 Enrolling
Amaze-CAP Madu Reddy, MD Sentre HEART To demonstrate that the adjunctive percutaneous LAA ligation procedure does not result in an unacceptable risk of serious adverse events (SAEs) in persistent or longstanding persistent AF subjects for whom a catheter ablation procedure is planned 11/13/2015 Enrolling
Amulet Matthew Earnest, MD St. Jude Medical
AMPLATZERTM AmuletTM Left Atrial Appendage (LAA) Occluder Randomized Controlled Trial - Watchman vs Amulet comparison
1/3/2017 In Follow-Up
Apollo Mark Wiley, MD Medtronic Multi-center, global, prospective, randomized, interventional, pre-market trial with two subject groups: the randomized group will be randomized on 1:1 basis to either the study device or to conventional mitral valve surgery. Subjects in the single-arm group will receive the study device. This trial is for patients with severe mitral regurgitation. 12/11/2017 Enrolling
Apollo-B Zubair Shah, MD Alnylam Pharmaceuticals A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Patisiran in Patients with Transthyretin Amyloidosis with Cardiomyopathy (ATTR Amyloidosis with Cardiomyopathy) 1/6/2020 In Follow-up
ARIES Travis Abicht, MD Abbott Antiplatelet Removal and HemocompatIbility Events with the HeartMate 3 Pump 7/19/2021 Enrolling
Beat HF Andrew Sauer, MD CVRx, Inc.
Baroreflex Activation Therapy in HFrEF
9/26/2017 In Follow-Up
BlueSync Martin Emert, MD Medtronic The purpose of this field evaluation is to collect and evaluate information related to CareLink transmission compliance as well as patient perceived benefit of BlueSync™ and the health care provider perception of the value of BlueSync™ and satisfaction with BlueSync™. 11/1/2017 Closed
CardioMEMS Registry Kamal Gupta, MD KUMC (IIT) A study of diurnal pattern of ambulatory pulmonary artery pressures in heart failure patients 3/31/2020 In Follow-Up
CHAMPION Madhu Reddy, MD Boston Scientific WATCHMAN FLX versus NOAC for Embolic Protection in the management of patients with Non-Valvular Atrial Fibrillation 6/18/2021 Enrolling
CHIEF Bhanu Gupta, MD Janssen This is a randomized, double-blind, placebo-controlled, decentralized, virtual, interventional, superiority study conducted in the US in participants with symptomatic HF (stratified by HFrEF and HFpEF) to examine the improvement in the KCCQ TSS after 3 months of treatment with canagliflozin 100 mg or placebo. The study will continue for an additional 6 months without any study intervention to collect participant follow-up in a real-world setting. 6/15/2020 In Follow-Up
COAPT Mark Wiley, MD Abbott Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation 3/1/2014 In Follow-Up
CR in PAD Kamal Gupta, MD KUMC (IIT)
Cardiac Rehab vs Standard of Care in PAD revasc.
5/4/2017 In Follow-Up
CREST II Kamal Gupta, MD NIH CREST-2 is two parallel multi-center randomized, observer-blinded endpoint clinical trials. One trial will assess treatment differences between intensive medical management alone compared to Carotid endarterectomy (CEA) plus intensive medical management. The parallel trial will assess treatment differences between intensive medical management alone compared to Carotid artery stenting (CAS) plus intensive medical management. Intensive medical management will involve control of blood pressure, LDL cholesterol, cigarette smoking, and other vascular risk factors. 2/21/2017 Enrolling
DEA-LAA- CA Madhu Reddy, MD VUMC/ Boston Scientific Efficacy of short- term dabigatran etexilate (Pradaxa) followed by aspirin monotherapy after LAA (left atrial appendage) device closure. 4/10/2020 In Follow-Up
DEA-LAA Madu Reddy, MD VUMC Efficacy of short- term dabigatran etexilate (Pradaxa) followed by aspirin monotherapy after LAA (left atrial appendage) device closure. 6/20/2019 In Follow-Up
DT/PAS-APOGEE Travis Abicht, MD Medtronic The HeartWare Destination Therapy (DT) PAS is a prospective, observational, multi-site study. Enrollment into the PAS will be comprised of newly enrolled, commercial use DT patients with the HVAD System. Medtronic is sponsoring the HVAD Post Approval Study (PAS) to further confirm safety and effectiveness of the HVAD when used as intended, in “real world” clinical practice. 5/20/2019 In Follow-Up
Eclipse Ashwani Mehta, MD Cardiovascular Systems, Inc. This trial will evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting stents (DES). 11/3/2017 In Follow-Up
ERR-CRT Study Seth Sheldon, MD KUMC (IIT) Assessment for Electrical Reverse Remodeling in Heart Failure patients on Entresto (Sacubitril/Valsartan) with Cardiac ResynchronizationTherapy (CRT) 5/27/2021 Enrolling
ExCeed Peter Tadros, MD Edwards Lifesciences, LLC A Prospective, Single-arm, Controlled, Multicenter Study to Establish the Safety and Effectiveness of the CENTERA THV System in Intermediate Risk Patients who have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement 3/2/2019 In Follow-Up
FMD Registry Kamal Gupta, MD FMDSA Registry of patients with FibromuscularDysplasia 1/2/2014 Enrolling
Guide HF Andrew Sauer, MD Abbott The GUIDE HF trial is intended to demonstrate the effectiveness of the CardioMEMS HF system in an expanded patient population outside the present indication but at risk for future HF events or mortality. GUIDE HF is the largest trial that the HF research team has participated in. KUMC finished second overall in the US in the randomized arm which closed December 2019. 6/20/2018 Enrolling
Ilumien Peter Tadros, MD St. Jude Medical The objective of this clinical investigation is to demonstrate the superiority of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as compared to an angiography-guided stent implantation strategy in achieving larger post-PCI lumen dimensions and improving clinical cardiovascular outcomes in patients with high-risk clinical characteristics and/or with high-risk angiographic lesions. 9/13/2018 Follow-Up
INTERPRET Andrew Sauer, MD Coram Clinical Trials The objective of the INTERPRET Registry is to collect and analyze data from HF populations that are undergoing inotropic treatment in the home care setting. 3/1/2019 Enrolling
ION Zubair Shah, MD Ionis Pharmaceuticals Inc. A Phase 3 Global, Double-Blind, Randomized, Placebo‑Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Transthyretin‑Mediated Amyloid Cardiomyopathy (ATTR CM) 1/4/2021 Enrolling
Leadless II Madu Reddy, MD St. Jude Medical A safety and effectiveness trial for a leadless pacemaker system 6/19/2014 Enrolling
MARVEN Madu Reddy, MD NIH Clinical, Electrocardiographic, and Cardiac Magnetic Resonance Imaging Risk Factors Associated with Ventricular Tachyarrhythmias in Nonischemic Cardiomyopathy (MARVEN Study) 4/26/2020 Enrolling
Myocarditis Biorepository Zubair Shah, MD KUMC (IIT) The development of a biorepository to directly analyze the myriad of inflammatory and biological markers will be the first step in developing future management of this disease state 3/10/2020 Enrolling
Nutrimedy Andrew Sauer, MD Heartlogic Use of Nutrimedy's Dietetic Counseling App in Patients Implanted with a HeartLogic TM Capable Device 6/22/2021 Enrolling
Inhaled Milrinone  Nicholas Haglund, MD Cumberland Emerging Technologies This trial is looking at the inhalation of milrinone, an inotrope, in hospitalized heart failure patients. 2/14/2020 In Follow-Up
OPTION Madhu Reddy, MD Boston Scientific The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high risk patients with non-valvular atrial fibrillation. 5/11/2020 In Follow-Up
Paraglide Andrew Sauer, MD Novartis Pharmaceuticals 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 (PARAGLIDE-HF). 9/13/2019 Enrolling
VENUS- HF Andrew Sauer, MD preCARDIA This trial uses the preCARDIA system as a therapeutic approach for helping acute diastolic heart failure patients who are not diuerising adequately with pharmacological agents while hospitalized. This trial is the first early feasibility trial that CCR has ever participated in. 8/5/2019 In Follow-Up
PREEMPT-HF Madu Reddy, MD Boston Scientific PREcision Event Monitoring of Patients with Heart Failure using HeartLogicTM (PREEMPT-HF) 2/12/2019 Enrolling
PROACTIVE Andrew Sauer, MD Endtronix A Prospective, Multi-Center, Randomized, Controlled, Single Blind Clinical Trial Evaluating the Safety and Efficacy of the CordellaTM Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class III Heart Failure Patients 5/28/2021 Enrolling
PSR Registry Martin Emert, MD Medtronic The purpose of the PSR platform is to provide continuing evaluation and periodic reporting of safety and effectiveness of market-released products for their intended use. PSR data will support post-market surveillance activities initiated by Medtronic and post-approval studies directed by a government and/or a regulatory authority. 11/3/2009 Enrolling
REPAIR Emmanuel Daon Abbott Percutaneous MitraClipTM Device or Surgical Mitral Valve Repair in Patients with Primary Mitral Regurgitation who are Candidates for Surgery 6/8/2021 Enrolling
Respiragen Nirmal Veeramachaneni, MD Hawkeye Bio, Inc. The primary objective of this study is to determine the analytic and clinical validity of the Hawkeye Lung Cancer Test (Respiragen) as a diagnostic tool for lung cancer using Low Dose CT (LDCT) and pathologically confirmed diagnosis as the confirmatory method.
The secondary objective of this study is to estimate the sensitivity and specificity of Respiragen as well as determining the sensitivity in the context of tumor volume. This will be evaluated with respect to both Non-Small Cell Lung Cancer and Small Cell Lung Cancer.
12/18/2019 On hold due to COVID
RESTORE Raghu Dendi, MD Lundbeck A clinical study of patients with symptomatic neurogenic orthostatic hypotension to assess Sustained effecTs Of droxidopa thErapy 6/11/2018 Enrolling
SHORE Nicholas Haglund, MD CareDX The purpose of this registry is to observe outcomes of heart transplant recipients who are managed with HeartCare. This is done by collecting information about your heart transplant such as test results, biopsy results, and outcomes, storing that information in a database and using that information for research. 10/19/20 Enrolling
Stellar Madu Reddy, MD Biosense Webster Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR) 10/11/2019 Follow-Up
SURTAVI Trip Zorn, MD Medtronic Surgical Replacement and Transcatheter Aortic Valve Implantation 12/25/2012 In Follow-Up
SWIFT Travis Abicht, MD Abbott Implantation of the HeartMate 3 in Subjects with Heart Failure using Surgical Techniques Other Than Full Median Sternotomy 7/14/2021 Enrolling
TAVR 2.0 Peter Tadros, MD Medtronic To evaluate the safety and efficacy of the Medtronic TAVR 2.0 system in SAS pts with high to extreme risk for SAVR 9/8/2016 In Follow-Up
TAVR Low Risk Trip Zorn, MD Medtronic Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement 8/22/2016 In Follow-Up
TRANSCEND Axel Thors, MD Surmodics 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 4/4/2018 In Follow-Up
Triluminate Peter Tadros, MD Abbott Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated with the Tricuspid Valve Repair System Pivotal in patients with severe, symptomatic tricuspid regurgitation.
(TRILUMINATE Pivotal)
12/31/2019 Enrolling
US Axillary Vein Access Seth Sheldon, MD KUMC (IIT) Ultrasound Axillary Vein Access: Evaluation of Learning Curve for an Alternative Approach to Cardiac Device Implantation 5/22/2020 In Follow-Up
Last modified: Apr 03, 2021
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