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 |
|---|---|---|---|---|---|---|
| ADVANTAGE AF | Madhu Reddy, M.D. | Quratulain Mushtaq | Boston Scientific | The FARAPULSE ADVANTAGE AF Study is a prospective, single arm, open label, multi-center IDE pivotal study utilizing the FARAPULSE PFA System in the treatment of patients with persistent atrial fibrillation. | 2/13/2023 | In Follow-up |
| AHF Biorepository | Zubair Shah, M.D. | Kartik Munshi | 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, M.D. | 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 |
| ALLIANCE | Trip Zorn, M.D. | Sofia Ruyle | Edwards Lifesciences, LLC | Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve | 1/31/2023 | Enrolling |
| ALLEVIATE | Madhu Reddy, M.D. | Quratulain Mushtaq | Medtronic | ALgorithm using LINQ Sensors for EValuatIon And TreatmEnt of Heart Failure | 4/4/2022 | Enrolling |
| Alt-Flow EFS | Mark Wiley, M.D. | Sofia Ruyle | Edwards Lifesciences, LLC | Early Feasibility Study of the Edwards Transcatheter Atrial Shunt System. A multi-center, prospective, early feasibility study. | 4/29/2020 | In Follow-Up |
| Alt-Flow II | Mark Wiley, M.D. | Sofia Ruyle | Edwards Lifesciences, LLC | A randomized, sham-controlled, clinical trial for evaluation of the Edwards APTURE transcatheter shunt system. | 9/6/2023 | Enrolling |
| Apollo | Mark Wiley, M.D. | Terry Christenson | 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, M.D. | 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 |
| ATRIUM | Charles Porter, M.D. | Terry Christenson | Bristol Myers Squibb | AbatacepT foR ImmUne checkpoint inhibitor associated Myocarditis (ATRIUM): A Phase 3, Investigator-Initiated, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Compared to Placebo in Hospitalized Participants with Immune Checkpoint Inhibitor Associated Myocarditis | 11/30/2022 | Enrolling |
| ASK-CHF2 | Zubair Shah, M.D. | Yolanda Murr | Asklepios BioPharmaceutical | A phase 2, adaptive, double-blinded, placebo controlled, randomized, multi-center trial to evaluate the efficacy, safety and tolerability of intracoronary infusion of AB-1002 in adult subjects with New York Heart Association (NYHA) Class III heart failure and non-ischemic cardiomyopathy | 1/24/2024 | Enrolling |
| BACKBEAT | Madhu Reddy, M.D. | Denetta Nelson | Orchestra BioMed | BradycArdia paCemaKer with AV interval modulation for Blood prEssure treAtmenT (BACKBEAT Trial). This is a prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel AV interval modulation (AVIM) algorithm downloaded into a previously implanted dual-chamber Medtronic pacemaker. | 5/29/24 | Enrolling |
| CATALYST | Raghu Dendi, M.D. | 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, M.D. | Denetta Nelson | Boston Scientific | WATCHMAN FLX versus NOAC for Embolic Protection in the management of patients with Non-Valvular Atrial Fibrillation | 6/18/2012 | In Follow-Up |
| Complete tavr | Peter Tadros, M.D. | Sofia Ruyle | 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, M.D. | Grace Millington | 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, M.D. | 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, M.D. | 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 |
| DEFINE GPS | Prasad Gunasekaran, M.D. | Ankita Tiwari | Phillips Image Guided Therapy Corporation | Distal Evaluation of Functional performance with Intravascular sensors to assess the Narrowing Effect: Guided Physiologic Stenting. | 7/12/2023 | Enrolling |
| DISCOVER-HCM | Loren Berenbom, M.D. | Grace Millington | Bristol Myers Squibb | Deliver Insights in Hypertrophic Cardiomyopathy and Observational Outcomes in Real World (DISCOVER-HCM): United States Prospective Registry Study | 12/15/2022 | Enrolling |
| DRAIN-HF | Zubair Shah, M.D. | Jillian Bruenn | Procyrion | DiuRetics Alone vs. AortIx ENdovascular Device for Acute Heart Failure | 2/21/2024 | Enrolling |
| DT/PAS-APOGEE | Matthew Danter, M.D. | 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, M.D. | 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 |
| EMPOWER | Prasad Gunasekaran, M.D. | Ankita Tiwari | Shockwave Medical, Inc. | Equity in Modifying Plaque Of WomEn with UndeRtreated Calcified Coronary Artery Disease. A post-market, prospective, multi-center, single-arm observational study to generate real-world clinical evidence associated with coronary IVL in a population of female subjects with calcified coronary artery disease. | 11/3/2023 | Enrolling |
| ERR-CRT Study | Seth Sheldon, M.D. | 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 |
| EVOLVE | Kamal Gupta, M.D. | Ankita Tiwari | Amgen, Inc. | A Pragmatic Randomized Multicenter Trial of EVOLocumab Administered Very Early to Reduce the Risk of Cardiovascular Events in Patients Hospitalized With Acute Myocardial Infarction | 3/31/2023 | In Follow-up |
| ENCIRCLE | Trip Zorn, M.D. | Terry Christenson | 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, M.D. | Kartik Munshi | 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 |
| FIRE-HFpEF | Seth Sheldon, M.D. | Quratulain Mushtaq | Medtronic | Fast Induced Remodeling in Heart Failure with Preserved Ejection Fraction | 1/10/2024 | Enrolling |
| FMD Registry | Kamal Gupta, M.D. | Grace Millington | FMDSA | Registry of patients with FibromuscularDysplasia | 1/2/2014 | Enrolling |
| GUARDIAN | Hirak Shah, M.D. | Kartik Munshi | 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 |
| HEAL-LAA | Madhu Reddy, M.D. | Denetta Nelson | Boston Scientific | Post-Market Real World Outcomes in WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device | 9/26/2023 | In Follow-Up |
| Histomap | Zubair Shah, M.D. | Kartik Munshi | CareDx | Assessment and Significance of Allograft Rejection in Heart Transplantation using HistoMap and Formalin Fixed Paraffin Embedded Tissue | 2/28/2023 | Enrolling |
| INTEGRA-D | Rhea Pimentel, M.D. | Quratulain Mushtaq | Impluse Dynamics, Inc. | Assessment of the Safety and Efficacy of a Combined Cardiac Contractility Modulation and Implantable Cardioverter Defibrillator Device for Subjects with Heart Failure and Reduced Ejection Fraction | 6/21/2023 | Enrolling |
| IONIS | Zubair Shah, M.D. | 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 |
| IONIS Open-Label | Zubair Shah, M.D. | Yolanda Murr | Ionis Pharmaceuticals Inc. | An Open-Label Extension Study to Assess the Long-Term Safety of Eplontersen (ION-682884) in Patients with Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM) | 3/1/2024 | In Follow-Up |
| LeAAPS | Omar Almogrhrabi, MD | Jillian Bruen | ArtiCure | Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial LeAAPS Trial - Prospective, concurrent, randomized control (1:1), blinded, multi-center, multinational, Investigational Device Exemption (IDE) clinical trial | 7/24/2024 | Enrolling |
| Librexia | Madhu Reddy, MD | Quratulain Mushtaq | Janssen Research and Development, LLC | A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active-Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants with Atrial Fibrillation | 7/29/2024 | Enrolling |
| LUX-Dx | Paola Roldan, M.D. | 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 | In Follow-Up |
| MAGICAL | Anthony Spaedy, MD | Gianna Grisafe | Concept Medical | A Prospective, Multicenter, Randomized, Two-Arm, Single-blind Superiority Trial to Evaluate the Safety and Efficacy of the MagicTouch™ Sirolimus-Coated Balloon in the Treatment of Coronary Drug-Eluting Stent In-Stent Restenosis. | 6/25/2024 | Enrolling |
| MARVEN | Madhu Reddy, M.D. | Denetta Nelson | NIH | Clinical, Electrocardiographic, and Cardiac Magnetic Resonance Imaging Risk Factors Associated with Ventricular Tachyarrhythmias in Nonischemic Cardiomyopathy (MARVEN Study) | 4/26/2020 | In Follow-Up |
| MUSIC | Pradeep Mammen, M.D. | Jillian Bruenn/Yolanda Murr | Sardocor Corp | A Phase 1b, Open-Label, Controlled Trial Evaluating the Safety and Efficacy of SRD-001 (AAV1/SERCA2a) in Subjects with Cardiomyopathy Secondary to Duchenne Muscular Dystrophy | 4/4/2024 | Enrolling |
| MVSS Registry | Emmanuel Daon, M.D. | Grace Millington | Medstar Cardiovascular Research Network | Mitral Valve Screening Survey (MVSS) - This multicenter prospective study will enroll consecutive subjects, who after referral for TMVI, are deemed not to be candidates for TMVI. | 10/26/2022 | Enrolling |
| Myocarditis Biorepository | Zubair Shah, M.D. | Kartik Munshi | 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 |
| Odyssey | Loren Berenbom, M.D. | Denetta Nelson | MyoKardia, Inc. | A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults with Symptomatic Non-obstructive Hypertrophic Cardiomyopathy | 3/9/3023 | In Follow-Up |
| OPTION | Madhu Reddy, M.D. | 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 |
| PerFOrm | George Hajj, M.D. | Ankita Tiwari | Encore Medical | This is a prospective, multicenter, randomized clinical study. Subjects will be randomized 1:1 to PFO closure with either the Encore PFO closure device (the investigational group) or any FDA-approved PFO closure device chosen by the investigator (the control group). | 4/14/2023 | Enrolling |
| PROACTIVE-HF | Hirak Shah, M.D. | Terry Christenson/Yolanda Murr | Endotronix | A Prospective, Multi-Center, Randomized, Controlled, Single Blind Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class III Heart Failure Patients | 5/28/2021 | In Follow-UP |
| PROACTIVE-HF-2 | Hirak Shah, M.D. | Yolanda Murr | Endotronix | A Prospective, Multi-Center, Open Label, Randomized Control Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class II - III Heart Failure Patients | 3/26/2024 | Enrolling |
| PROTECT_REN-007 | Matthew Danter, M.D. | Terry Christenson | Renibus Therapeutics | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of RBT-1 on Reducing the Risk of PostOperative Complications in Subjects Undergoing Cardiac Surgery (The PROTECT Study) | 9/4/2024 | Enrolling |
| PSR Registry | Martin Emert, M.D. | 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 |
| RADICAL PC | Charles Porter, M.D. | Terry Christenson | PHRI | RADICAL PC1 is a prospective cohort study of men with a new diagnosis of prostate cancer. RADICAL PC2 is a randomized, controlled trial of a systematic approach to modifying cardiovascular and lifestyle risk factors in men with a new diagnosis of prostate cancer. | 12/12/2022 | Enrolling |
| REPAIR | Emmanuel Daon | Sofia Ruyle | Abbott | Percutaneous MitraClip™ Device or Surgical Mitral Valve Repair in Patients with PrImaRy Mitral Regurgitation who are Candidates for Surgery | 6/8/2021 | Enrolling |
| SCALE HF | Hirak Shah, M.D. | Kartik Munshi | Bodyport, Inc. | SurveillanCe and Alert-based multiparameter monitoring to reducE worsening Heart Failure events | 12/15/2021 | In Follow-Up |
| SHORE | Zubair Shah, M.D. | Kartik Munshi | 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, M.D. | Sofia Ruyle | 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 | In Follow-Up |
| SMARTPulse PAF | Madhu Reddy, M.D. | Quratulain Mushtaq | Biosense Webster, Inc. | Safety and Effectiveness Evaluation of THERMOCOOL SMARTTOUCH™ SF Catheter with the TRUPULSE™ Generator for treatment of drug refractory symptomatic Paroxysmal Atrial Fibrillation (PAF) | 3/20/2024 | Enrolling |
| SOLVE | Madhu Reddy, M.D. | 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 | In Follow-Up |
| SURTAVI | Trip Zorn, M.D. | Terry Christenson | Medtronic | Surgical Replacement and Transcatheter Aortic Valve Implantation | 12/25/2012 | In Follow-Up |
| TARGET | Eric Hockstad, M.D. | Grace Millington | Shanghai MicroPort Medical (Group) Co., Ltd. | Multicenter Randomized Assessment of the Firehawk® rapamycin TARGET eluting cobalt chromium coronary stent system. | 10/21/2021 | In Follow-Up |
| TAVR Low Risk | Trip Zorn, M.D. | Terry Christenson | 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, M.D. | Kartik Munshi | 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, M.D. | Terry Christenson | 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 |
| TRISCEND II | Peter Tadros, M.D. | Terry Christenson | Edwards Lifesciences, LLC | This is a prospective, global, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the EVOQUE system with OMT compared to OMT alone in the treatment of patients with at least severe TR using an expedited and extended phase design. | 12/15/2022 | In Follow-Up |
| US Axillary Vein Access | Seth Sheldon, M.D. | 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-PLAQUE | Tom Rosamond, M.D. | Denetta Nelson | Novartis Pharmaceuticals | A multi-center, randomized, double-blind, placebo-controlled, parallel-group Phase IIIb study evaluating inclisiran in plaque regression assessed by Coronary Computed Tomography Angiography (CCTA) in participants without previous cardiovascular events and a diagnosis of non-obstructive coronary artery disease. | 12/14/2022 | Enrolling |
| VICTORION-2 PREVENT | Mazhar Afaq, M.D. | 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 | In Follow-Up |
| VITAL-HF | Hirak Shah, M.D. | Ankita Tiwari | Story Health Corporation | A multicenter, randomized, 6-month study to evaluate the safety and efficacy of a remote, digital intervention targeting heart failure medications versus usual care in participants with heart failure with reduced ejection fraction | 7/26/2023 | Enrolling |