Clinical Trials
Innovative and groundbreaking clinical research trials are underway in our department and actively enrolling participants.
Study Name | PI | Study Coordinator | Sponsor | Description | Began | Status |
---|---|---|---|---|---|---|
AHF Biorepository | Zubair Shah, MD | Ashkaun Adib-Yaghmaee | 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 |
AIM Higher | Hirak Shah, MD | Alyssa Boyce-White | Impulse Dynamics, Inc. | The purpose of this trial to evaluate the Optimizer Smart Mini Systems in patients with symptomatic heart failure with an ejection fraction between 40-60% and to determine whether CCM therapy can improve health status and functional capacity. | 3/18/2022 | Enrolling |
ALLEVIATE | Madhu Reddy, MD | Quratulain Mushtaq | Medtronic | ALgorithm using LINQ Sensors for EValuatIon And TreatmEnt of Heart Failure | 4/4/2022 | Enrolling |
Alt-Flow | Mark Wiley, MD | Tilitha Shawgo | Edwards Lifesciences, LLC | Early Feasibility Study of the Edwards Transcatheter Atrial Shunt System. A multi-center, prospective, early feasibility study. | 4/29/2020 | Enrolling |
Amulet | Matthew Earnest, MD | Quratulain Mushtaq | 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 | Tilitha Shawgo | 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 | Yolanda Murr | 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 | Terry Christenson | Abbott | Antiplatelet Removal and HemocompatIbility Events with the HeartMate 3 Pump | 7/19/2021 | Enrolling |
Beat HF | Bhanu Gupta, MD | Alyssa Boyce-White | CVRx, Inc. | Baroreflex Activation Therapy in HFrEF |
9/26/2017 | In Follow-Up |
CardioMEMS Registry | Kamal Gupta, MD | Kartik Munshi | KUMC (IIT) | A study of diurnal pattern of ambulatory pulmonary artery pressures in heart failure patients | 3/31/2020 | Enrolling in sub-study |
CATALYST | Raghu Dendi, MD | Denetta Nelson | 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 | Denetta Nelson | Boston Scientific | WATCHMAN FLX versus NOAC for Embolic Protection in the management of patients with Non-Valvular Atrial Fibrillation | 6/18/2012 | Enrolling |
COAPT | Mark Wiley, MD | Tilitha Shawgo | Abbott | Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation | 3/1/2014 | In Follow-Up |
Complete TAVR | Peter Tadros, MD | Stephanie Greer | University of British Columbia (UBC) | A Randomized, Comparative Effectiveness Study of Staged Complete Revascularization with Percutaneous Coronary Intervention to Treat Coronary Artery Disease vs Medical Management Alone in Patients with Symptomatic Aortic Valve Stenosis undergoing Elective Transfemoral Transcatheter Aortic Valve Replacement | 11/30/2021 | Enrolling |
ConTTribute | Zubair Shah, MD | Yolanda Murr | Alnylam Pharmaceuticals | A prospective, global, multicenter, long-term observational study designed to document the clinical outcomes of patients with hereditary transthyretin-mediated (ATTRv) amyloidosis or wild-type transthyretin-mediated (ATTRwt) amyloidosis, and the safety of patisiran (Onpattro®) when used in patients with ATTRv amyloidosis (also referred to as hATTR amyloidosis) | 12/23/2021 | Enrolling |
CREST II | Kamal Gupta, MD | Terry Christenson | 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 | Denetta Nelson | 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 | Madhu Reddy, MD | Denetta Nelson | 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 | Becca Johnson | 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 | Yolanda Murr | 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 | Kartik Munshi | KUMC (IIT) | Assessment for Electrical Reverse Remodeling in Heart Failure patients on Entresto (Sacubitril/Valsartan) with Cardiac Resynchronization Therapy (CRT) | 5/27/2021 | Enrolling |
ENCIRCLE | Trip Zorn, MD | Tilitha Shawgo | Edwards Lifesciences, LLC | Prospective, single-arm, multicenter, adaptive design study to establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomic or technical considerations | 12/10/2021 | Enrolling |
ExCeed | Peter Tadros, MD | Tilitha Shawgo | 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 | Becca Johnson | FMDSA | Registry of patients with FibromuscularDysplasia | 1/2/2014 | Enrolling |
Guide HF | Hirak Shah, MD | Alyssa Boyce-White | 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 | Becca Johnson | 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 | Denetta Nelson | 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 |
Inhaled Milrinone | Zubair Shah, MD | Alyssa Boyce-White | 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 |
ION | Zubair Shah, MD | Yolanda Murr | 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 | Rhea Pimentel, MD | Denetta Nelson | St. Jude Medical | A safety and effectiveness trial for a leadless pacemaker system | 6/19/2014 | In Follow-ip |
LUX-Dx | Bhanu Gupta, MD | Alyssa Boyce-White | Boston Scientific | The primary objective of this study is to collect physiological measurement data and heart failure (HF) event data that will be used to design and develop new diagnostic features for the insertable cardiac monitor (ICM) systems. | 1/27/2022 | Enrolling |
MARVEN | Madhu Reddy, MD | Denetta Nelson | 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 | Ashkaun Adib-Yaghmaee | 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 | Quratulain Mushtaq | 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 | Zubair Shah, MD | Alyssa Boyce-White | Heartlogic | Use of Nutrimedy's Dietetic Counseling App in Patients Implanted with a HeartLogic TM Capable Device | 6/22/2021 | Enrolling |
OPTION | Madhu Reddy, MD | Denetta Nelson | 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 | Andrija Vidic, MD | Stephanie Greer | 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 | In Follow-Up |
PROACTIVE | Hirak Shah, MD | Alyssa Boyce-White | 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 | Quratulain Mushtaq | 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 | Tilitha Shawgo | Abbott | Percutaneous MitraClipTM Device or Surgical Mitral Valve Repair in Patients with PrImaRy Mitral Regurgitation who are Candidates for Surgery | 6/8/2021 | Enrolling |
RESTORE | Raghu Dendi, MD | Quratulain Mushtaq | 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 | Terry Christenson | 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 |
SCALE HF | Hirak Shah, MD | Alyssa Boyce-White | Bodyport, Inc. | SurveillanCe and Alert-based multiparameter monitoring to reducE worsening Heart Failure events | 12/15/2021 | Enrolling |
SHORE | Andrija Vidic, MD | Stephanie Greer | 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 | In Follow-Up |
SMART | Trip Zorn, MD | Tilitha Shawgo | 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 | Quratulain Mushtaq | EBR Systems, Inc. | Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders and Previously Untreatable Patients. | 10/14/2021 | Enrolling |
Stellar | Madhu Reddy, MD | Quratulain Mushtaq | 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 | Tilitha Shawgo | Medtronic | Surgical Replacement and Transcatheter Aortic Valve Implantation | 12/25/2012 | In Follow-Up |
TARGET | Eric Hockstad, MD | Stephanie Greer | 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 Low Risk | Trip Zorn, MD | Tilitha Shawgo | 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 |
TEAMMATE | Andrija Vidic, MD | Stephanie Greer | CareDx | Technology Enabled And Molecular Monitoring of the Allograft and Transplant rEcipient to assess the impact of AlloCare mHealth remote monitoring on the early post-transplant period | 4/4/2022 | Enrolling |
TRANSCEND | Axel Thors, MD | Tilitha Shawgo | 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 |
TRIBE-HF | Zubair Shah, MD | Alyssa Boyce-White | General Prognostics | This is a pilot, single-center, prospective, observational study (N=10 patients) to assess the feasibility, implementation, and adherence of remote patient monitoring (RPM) with the GPx monitoring platform in patients with HFrEF and NYHA symptoms class III. Patients will be followed up for one month after enrolment. | 11/5/2021 | Enrolling |
Triluminate | Peter Tadros, MD | Tilitha Shawgo | 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 | Kartik Munshi | KUMC (IIT) | Ultrasound Axillary Vein Access: Evaluation of Learning Curve for an Alternative Approach to Cardiac Device Implantation | 5/22/2020 | In Follow-Up |