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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