Active Trials
Working with researchers at Baylor Scott & White Health and institutions around the globe, our physicians, surgeons and advanced practice providers oversee a wide selection of clinical trials.
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				Study Name: MonarQ EFS
									Study Title: A Clinical Study of the inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System 								
				
									Sponsor: inQb8								
				
									PI: Smith Ii								
				
									Therapeutic Group: Cardiology								
				Study Name: OCEAN-a
									Study Title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Olpasiran on major Cardiovascular Events in Patients with Atherosclerotic CV Disease and Elevated Lipoprotein (a)								
				
									Sponsor: Amgen								
				
									PI: East								
				
									Therapeutic Group: Cardiology								
				Study Name: VESALIUS
									Study Title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Impact of Evolocumab on Major Cardiovascular Events in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke								
				
									Sponsor: Amgen								
				
									PI: East								
				
									Therapeutic Group: Cardiovascular Surgery								
				Study Name: JenaValve CAP/EFS
									Study Title: A Feasibility Study to Assess Safety and Effectiveness of the Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients with Symptomatic Severe Aortic Stenosis (AS) or Aortic Regurgitation (AR)								
				
									Sponsor: JenaValve Technology, Inc.								
				
									PI: Szerlip								
				
									Therapeutic Group: Vascular								
				Study Name: TiGER
									Study Title: A Global Post Market Evaluation of Terumo Aortic Endovascular Grafts								
				
									Sponsor: Terumo								
				
									PI: Gable								
				
									Therapeutic Group: Electrophysiology								
				Study Name: TRIOMPHE
									Study Title: A Multi-arm, Multi-Center, Non-Randomized, Prospective, Clinical Study to Evaluate the Safety and Effectiveness of the NEXUSTM Aortic Arch Stent Graft System in Treating Thoracic Aortic Lesions Involving the Aortic Arch (TRIOMPHE Study)								
				
									Sponsor: Endospan								
				
									PI: Brinkman								
				
									Therapeutic Group: Cardiovascular Surgery								
				Study Name: COMET-HF
									Study Title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial To Assess Efficacy And Safety Of Omecamtiv Mecarbil In Patients With Symptomatic Heart Failure With Severely Reduced Ejection Fraction (COMET HF)								
				
									Sponsor: Cytokinetics								
				
									PI: Bindra/Kabra								
				
									Therapeutic Group: Cardiology								
				Study Name: PLAQUE
									Study Title: A multi-center, randomized, double-blind, placebo-controlled, parallel -group Phase IIIb study evaluating the effect of inclisirin on atherosclerotic plaque progression assessed by coronary computed tomography angiography (CCTA) in participants with a diagnosis of non-obstructive coronary artery disease without previous cardiovascular events								
				
									Sponsor: Novartis								
				
									PI: East								
				
									Therapeutic Group: Electrophysiology								
				Study Name: C-Guardians
									Study Title: A Multicenter, Single-Arm, Pivotal Study to Evaluate the Safety and Efficacy of the CGuard™ Carotid Stent System When Used to Treat Symptomatic and Asymptomatic Carotid Artery Stenosis in Patients Undergoing Carotid Artery Stenting								
				
									Sponsor: InspireMD								
				
									PI: Das								
				
									Therapeutic Group: Aortic Valve								
				Study Name: RENEU-HF
									Study Title: A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of JK07 in Adults With Chronic Heart Failure (RENEU-HF)								
				
									Sponsor: Salubris								
				
									PI: Hsi								
				
									Therapeutic Group: Vascular								
				Study Name: GenePHIT
									Study Title: 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.								
				
									Sponsor: AskBio								
				
									PI: Gottlieb								
				
									Therapeutic Group: Electrophysiology								
				Study Name: EZDB
									Study Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3540378 in Adults with Worsening Chronic Heart Failure with Preserved Ejection Fraction (HFpEF)								
				
									Sponsor: Eli Lilly and Company								
				
									PI: Guerrero Miranda								
				
									Therapeutic Group: Tricuspid								
				Study Name: Cardurion Cycle-2
									Study Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Safety and Effectiveness of Tovinontrine in Patients With Chronic Heart Failure With Preserved Ejection Fraction								
				
									Sponsor: Cardurion								
				
									PI: Hsi								
				
									Therapeutic Group: Cardiovascular Surgery								
				Study Name: Cardurion Cycle-1
									Study Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Safety and Effectiveness of Tovinontrine in Patients With Chronic Heart Failure With Reduced Ejection Fraction								
				
									Sponsor: Cardurion								
				
									PI: Hsi								
				
									Therapeutic Group: Heart Failure								
				Study Name: ACCESS
									Study Title: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Dose-range Finding Study of the Efficacy and Safety of Multiple Doses of GSBR-1290 in Participants Living with Obesity (Body Mass Index ≥ 30 kg/m2) or Overweight (Body Mass Index ≥ 27 kg/m2) with at Least One Weight-related Comorbidity								
				
									Sponsor: Gasherbrum Bio, Inc.								
				
									PI: East								
				
									Therapeutic Group: Heart Failure								
				Study Name: LEVEL
									Study Title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction (PH-HFpEF); LEVEL: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF								
				
									Sponsor: Tenax Therapeutics								
				
									PI: Al-Saffar/Kabra								
				
									Therapeutic Group: Cardiology								
				Study Name: UNISUS
									Study Title: A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg. (UNISUS)								
				
									Sponsor: Janssen Research & Development, LLC								
				
									PI: Bakshi								
				
									Therapeutic Group: Cardiology								
				Study Name: LIBREXIA AF
									Study Title: 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								
				
									Sponsor: Janssen Research & Development, LLC								
				
									PI: Banchs								
				
									Therapeutic Group: Heart Failure								
				Study Name: PROSERA
									Study Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Inhalation of Seralutinib for the Treatment of Pulmonary Arterial Hypertension (PAH) – Gossamer 3101								
				
									Sponsor: Gossamer Bio, Inc.								
				
									PI: Bakshi								
				
									Therapeutic Group: Heart Failure								
				Study Name: ENTRUST
									Study Title: A phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Severe Hypertriglyceridemia (SHTG)								
				
									Sponsor: 89bio, Inc.								
				
									PI: East								
				
									Therapeutic Group: Heart Failure								
				Study Name: ACCLAIM
									Study Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults with Elevated Lipoprotein(a) who have Established Atherosclerotic Cardiovascular Disease or Are at Risk for a First Cardiovascular Event – ACCLAIM-Lp(a)								
				
									Sponsor: Eli Lilly and Company								
				
									PI: East								
				
									Therapeutic Group: Heart Failure								
				Study Name: LIBREXIA-ACS
									Study Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Event-driven Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, After a Recent Acute Coronary Syndrome								
				
									Sponsor: Janssen Research & Development, LLC								
				
									PI: Sathyamoorthy								
				
									Therapeutic Group: Cardiology								
				Study Name: TRIUMPH
									Study Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Retatrutide on the Incidence of Major Adverse Cardiovascular Events and the Decline in Kidney Function in Participants with Body Mass Index (BMI) ≥27 kg/m2 and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease								
				
									Sponsor: Eli Lilly and Company								
				
									PI: East								
				
									Therapeutic Group: Cardiology								
				Study Name: SELUTION4SFA
									Study Title: A Prospective Randomized Multicenter Single Blinded Study to Assess the Safety and Efficacy of the SELUTION SLR™ 018 Drug Eluting Balloon in the Treatment of Subjects with Femoropopliteal Artery Lesions								
				
									Sponsor: M.A. Med Alliance S.A.								
				
									PI: Sayfo								
				
									Therapeutic Group: Vascular								
				Study Name: SELUTION 4 De Novo Small Vessel IDE
									Study Title: A Prospective Randomized Single-Blind Multicenter Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 PTCA Drug Eluting Balloon in the Treatment of Subjects With De Novo Coronary Lesions in Small Vessels								
				
									Sponsor: M.A. Med Alliance S.A.								
				
									PI: Stoler/Widmer/Sayfo								
				
									Therapeutic Group: Cardiology								
				Study Name: Evaheart
									Study Title: A Prospective Study to Evaluate the Safety and Efficacy of the Evaheart LVAS for Use as a Bridge-To-Transplant								
				
									Sponsor: Evaheart								
				
									PI: Meyer								
				
									Therapeutic Group: Heart Failure								
				Study Name: AGILITY
									Study Title: A Prospective, Multi-Center, Non-Randomized, SinGle-Arm Study of the BDTM Low ProfILe Vascular Covered Stent in PerIpheral ArTerY Disease (AGILITY)								
				
									Sponsor: Bard Peripheral Vascular, Inc. 								
				
									PI: Sayfo								
				
									Therapeutic Group: Vascular								
				Study Name: PROACTIVE- HF-2 Trial
									Study Title: 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								
				
									Sponsor: Endotronix								
				
									PI: Guerrero Miranda/Hernandez-Montfort								
				
									Therapeutic Group: Aortic Valve								
				Study Name: BOLT
									Study Title: A Prospective, Multicenter Study of Patients with Deep Vein Thrombosis to Evaluate the Safety and Efficacy of the Indigo Aspiration System								
				
									Sponsor: Penumbra, Inc.								
				
									PI: Vasquez								
				
									Therapeutic Group: Vascular								
				Study Name: Relay-ProA
									Study Title: A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects with Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers (RelayPro)								
				
									Sponsor: Bolton Medical								
				
									PI: Brinkman								
				
									Therapeutic Group: Vascular								
				Study Name: AGENT (LONG LESION)
									Study Title: A Prospective, Randomized (2:1), Multicenter Trial to Assess the Safety and Effectiveness of the AgentTM Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects with In-Stent Restenosis (ISR)								
				
									Sponsor: Boston Scientific Corporation								
				
									PI: Stoler								
				
									Therapeutic Group: Vascular								
				Study Name: Partner 3 Main & CAP
									Study Title: A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Requiring Aortic Valve Replacement who have Severe, Calcific, Symptomatic Aortic Stenosis – PARTNER 3 Low-Risk Continued Access								
				
									Sponsor: Edwards Lifesciences								
				
									PI: Szerlip/Mack								
				
									Therapeutic Group: Heart Failure								
				Study Name: Emblok
									Study Title: A Prospective, Randomized, Multicenter Evaluation of the Safety and Effectiveness of the EMBLOK™ Embolic Protection System during Transcatheter Aortic Valve Replacement 								
				
									Sponsor: Innovative Cardiovascular Solutions, LLC								
				
									PI: Potluri								
				
									Therapeutic Group: Vascular								
				Study Name: PERSEVERE
									Study Title: A ProspEctive, Single ARm, Multi-center Clinical InveStigation to EValuatE the Safety and Effectiveness of the AMDS in the TREatment of Acute DeBakey Type I Dissection: PERSEVERE								
				
									Sponsor: CryoLife, Inc.								
				
									PI: Brinkman								
				
									Therapeutic Group: Cardiology								
				Study Name: ExCEED
									Study Title: 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								
				
									Sponsor: Edwards Lifesciences								
				
									PI: Stoler/Mixon/Szerlip								
				
									Therapeutic Group: Heart Failure								
				Study Name: Partner 3 AViV
									Study Title: A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3//SAPIEN 3 Ultra Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve.								
				
									Sponsor: Edwards Lifesciences								
				
									PI: Szerlip/Mack								
				
									Therapeutic Group: Vascular								
				Study Name: PREVAIL GLOBAL
									Study Title: A randomized controlled study of the Prevail Drug-Coated Balloon in subjects with in-stent restenosis and a single arm prospectively enrolled study of the Prevail Drug-Coated Balloon for de novo lesions in small vessel disease (Prevail Global)								
				
									Sponsor: Medtronic Vascular								
				
									PI: Stoler								
				
									Therapeutic Group: Heart Failure								
				Study Name: HORIZON
									Study Title: A randomized double-blind, placebo-controlled, multicenter trial assessing the impact of lipoprotein (a) lowering with TQJ230 on major cardiovascular events in patients with established cardiovascular disease								
				
									Sponsor: Novartis								
				
									PI: East								
				
									Therapeutic Group: Cardiology								
				Study Name: COMPLETE TAVR
									Study Title: 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: The COMPLETE TAVR Study								
				
									Sponsor: University of British Columbia								
				
									PI: Potluri/Condado Contreras								
				
									Therapeutic Group: Vascular								
				Study Name: ODYSSEY-HCM
									Study Title: A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy								
				
									Sponsor: Bristol Myers Squibb Company								
				
									PI: Afzal/Gottlieb								
				
									Therapeutic Group: Electrophysiology								
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