Research

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	Poonam Bhyan	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	Quratulain Mushtaq	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
ANTHEM	Hirak Shah, MD	Eva Adams	LivaNova	Autonomic Regulation Therapy to Enhance Myocardial Function and Reduce Progression of Heart Failure with Reduced Ejection Fraction (ANTHEM-HFrEF Pivotal Study)	9/1/2022	Enrolling
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	In Follow-Up
Beat HF	Bhanu Gupta, MD	Yolanda Murr	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
EAP ALN-TTR02-014	Zubair Sha, MD	Yolanda Murr	Alnylam Pharmaceuticals	This patisiran expanded access protocol (EAP) is an open-label, multicenter, single-arm study designed to provide pre-approval access to investigational patisiran for patients with ATTR amyloidosis with cardiomyopathy (hereditary or wild-type [wt]) who, at baseline, have an inadequate response to or cannot tolerate standard of care.	8/2/2022	Enrolling
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
GUARDIAN	Andrija Vidic, MD	Stephanie Greer	Paragonix Technologies	GUARDIAN is a post-market, observational registry of adult and pediatric heart transplant recipient patients whose donor heart was preserved and transported within the SherpaPak Cardiac Transport System. The data is being collected retrospectively from medical records of patients already transplanted before the initiation of the registry and any new patients who meet the eligibility criteria.	6/14/2022	Enrolling
Guide HF	Hirak Shah, MD	Terry Christenson/ Yolanda Murr	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	In Follow-Up
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
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	In Follow-Up
LUX-Dx	Bhanu Gupta, MD	Denetta Nelson	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	Poonam Bhyan	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	Kartik Munshi	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
PADMA	Alykhan Nagji, MD	Becca Johnson	Oncocyte Corp	Prospective, non-randomized, multi-center registrational study where all patients diagnosed with resected stage I to IIA (T < or = 5cm, N0) (AJCC 8th edition) non-squamous NSCLC who meet the intended use criteria for testing with DetermaRxTM are eligible for enrollment. After testing with DetermaRxTM a treatment decision visit will occur, and an adjuvant treatment plan will be determined as either: 1) four cycles of adjuvant treatment with a standard NSCLC platin-based doublet regimen of physician choice 2) adjuvant therapy with combination therapy of chemotherapy with targeted therapy and/or immunotherapy or targeted therapy alone or 3) observation only.	7/20/2022	Enrolling
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	Terry Christenson/ Yolanda Murr	Endtronix	A Prospective, Multi-Center, Randomized, Controlled, Single Blind Clinical Trial Evaluating the Safety and Efficacy of the Cordella^TM 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	In Follow-Up
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	Becca Johnson	Bodyport, Inc.	SurveillanCe and Alert-based multiparameter monitoring to reducE worsening Heart Failure events	12/15/2021	In Follow-Up
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
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	Kartik Munshi	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 enrollment.	11/5/2021	Closing/td>
TRIBE-HF II	Zubair Shah, MD	Eva Adams	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 enrollment.	8/31/2022	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
VICTORION-2 PREVENT	Mazhar Afaq, MD	Terry Christenson	Novartis Pharmaceuticals	A randomized, double-blind, placebo-controlled, multicenter trial, assessing the impact of inclisiran on major adverse cardiovascular events in participants with established cardiovascular disease.	7/29/2022	Enrolling