Clinical Trials
Innovative and groundbreaking clinical research trials are underway in our department and actively enrolling participants.
| Study Name | PI | Sponsor | Description | Began | Status |
|---|---|---|---|---|---|
| ADC | Andrew Sauer, MD | Abbott | A Sensor Based Monitoring System for Metabolic Signatures of Congestive Heart Failure Status, an Exploratory Study | 5/28/2021 | In Follow-Up |
| AHF Biorepository | Zubair Shah, 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 | Paused |
| 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 |
| BioAffect | Amit Noheria, MD | Biotronik | Atrial Fibrillation associated with Heart Failure treated by BIOTRONIK’s CRT-DX System | 9/10/2021 | Enrolling |
| 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 |
| CATALYST | Raghu Dendi, MD | Abbott | Prospective, randomized, controlled, unblinded, multicenter clinical trial of the Amplatzer™ Amulet™ device in patients with non-valvular atrial fibrillation who are at increased risk for cardioembolic events. | 10/12/2021 | Enrolling |
| CHAMPION | Madhu Reddy, MD | Boston Scientific | WATCHMAN FLX versus NOAC for Embolic Protection in the management of patients with Non-Valvular Atrial Fibrillation | 6/18/2012 | 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 |
| 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 |
| DEFINE | Seth Sheldon, MD | Medtronic | The purpose of this study is to evaluate the association between complex patterns of device-detected AF and other summary and episodic measurements collected by the LINQ ICM device and AF-related healthcare utilization, quality of life, AF-related symptoms, and specific clinical outcomes in patients with a market-released LINQ ICM. | 11/5/2021 | Enrolling |
| 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 |
| ERR-CRT Study | Seth Sheldon, MD | KUMC (IIT) | Assessment for Electrical Reverse Remodeling in Heart Failure patients on Entresto (Sacubitril/Valsartan) with Cardiac Resynchronization Therapy (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 |
| Hawkeye | Nirmal Veeramachaneni, MD | Hawkey 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. |
12/18/2021 | 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 |
| 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 |
| Newton | Madhu Reddy, MD | Boston Scientific | To demonstrate the safety and effectiveness of the IntellaNav StablePoint Catheter and Force Sensing System with DIRECTSENSE for treatment of drug refractory, recurrent, symptomatic Paroxysmal Atrial Fibrillation (PAF). | 9/9/2021 | 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 | Zubhair Shah, 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 |
| Respirix II | Kamal Gupta, MD | Respirix, Inc. | Observational study to collect paired readings of the Cardiospire cardiogenic oscillation signal (COS) and the ground truth CO output parameters, including Pulmonary Artery Pressure diastolic (PAPd), systolic (PAPs), Stroke Volume (SV), and Cardiac Output (CO) from the Pulmonary Artery Catheter in intubated patients. | 8/27/2021 | 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 |
| SMART | Trip Zorn, MD | Medtronic | The purpose of this trial is to generate clinical evidence on valve safety and performance of self‐expanding (SE) versus balloon‐expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic annulus and symptomatic severe native aortic stenosis. | 8/27/2021 | Enrolling |
| SOLVE | Madhu Reddy, MD | EBR Systems, Inc. | Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders and Previously Untreatable Patients. | 10/14/2021 | Enrolling |
| STEP | Andrew Sauer, MD | Novo Nordisk, Inc. | Effect of semaglutide 2.4 mg once weekly on function and symptoms in subjects with obesity-related heart failure with preserved ejection fraction. | 10/18/2021 | 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 |
| TARGET | Eric Hockstad, MD | Shanghai MicroPort Medical (Group) Co., Ltd. | Multicenter Randomized Assessment of the Firehawk® rapamycin TARGET eluting cobalt chromium coronary stent system. | 10/21/2021 | 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 |