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Collin County
ELEGANCE- Drug-ELuting REGistry: ReAl-World Treatment of LesioNs in the Peripheral VasCulaturE
Description:
Collection of Real-World Data (RWD), including populations previously not represented in Peripheral Vascular Disease (PVD) trails, health economics data, and to support the safe use of commercially available Boston Scientific Corporation (BSC) drug-eluting devices for the treatment of lesions located in the peripheral vasculature.
Principal Investigator:
Dr. Vijay Ramanath
Contact:
Shelley Long | Email | 972-981-7629
Locations:
HeartPlace Plano West
Funded By:
Boston Scientific Corporation
IRB#:
STU-2022-0195
A Prospective, Multicenter, Single Blind, Randomized Controlled Trial Evaluating the Safety and Effectiveness of the MOTIV Sirolimus-Eluting Bioresorbable Vascular Scaffold Compared with Plain Balloon Angioplasty for the Treatment of Infrapopliteal Lesions
Description:
Pre-market clinical evaluation of the MOTIV Sirolimus-Eluting Bioresorbable Scaffold for the planned treatment of infrapopliteal lesions
Principal Investigator:
Dr. Vijay Ramanath
Contact:
Shelley Long | Email | 972-981-7629
Location(s):
HeartPlace Plano West
Funded By:
REVA Medical, LLC
IRB#:
STU-2023-0498
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Dallas CountyDallas County New Content
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, 4-Arm Study to Investigate Symptoms, Function, Health-Related Quality of Life and Safety with Repeated Subcutaneous Administration of Ponsegromab Versus Placebo in Adult Participants with Heart Failure
Description:
The primary purpose of this study is to assess the effect of repeated SC administration of ponsegromab (PF-06946860) on frequency, severity, and burden of symptoms as well as physical limitations in participants with HF and elevated circulating GDF-15 concentrations. The study will also assess the safety, tolerability, PK, PD, and immunogenicity of ponsegromab. A separate, open-label, PK cohort, with more frequent PK and GDF-15 collection after single and multiple SC administration of ponsegromab, will be enrolled at certain sites in the US and Canada to facilitate a more comprehensive assessment of PK characteristics and PK/PD relationship for GDF-15 in participants with HF.
Principal Investigator:
Dr. Martin Berk
Contact:
Tram Nguyen | Email | 214.369.3613
Locations:
THPG – Dallas
Funded By:
Pfizer
IRB#:
STU-2022-0684
Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure -Thrombolysis in Myocardial Infarction 68 (DAPA ACT HF-TIMI 68)
Description:
A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Trial to Evaluate the Effect of In-Hospital Initiation of Dapagliflozin on Clinical Outcomes in Patients Who Have Been Stabilized During Hospitalization for Acute Heart FailurePrincipal Investigator:
Dr Martin BerkContact:
Tram Nguyen |Email|214.369.3613Location(s):
THPG – Dallas and TH DallasFunded By:
AstraZenecaIRB#:
STU-2021-0929
Cryo Global Registry
Sub-Study #1: STOP Persistent AF Post-Approval Sub-Study to the Cryo Global Registry
Sub-Study #2 (coming soon): STOP AF First Post-Approval Study, an Addendum to the Cryo Global RegistryDescription:
A base clinical investigation plan in the Medtronic Cardiac Ablation Post-Market Study Platform
Sub-Study #1: The purpose of the PAS is to describe the long-term clinical performance and safety data in the Persistent AF population treated with Artic Front Cardiac Cryoablation Catheter System.
Sub-Study #2: The purpose of the study is to describe long-term clinical performance and safety data in the recurrent symptomatic paroxysmal AF population treated with Artic Front Cardiac Cryoablation Catheter System as an alternative to antiarrhythmic drug therapy as an initial rhythm control strategy.Principal Investigator:
Dr. Charles Lampe
Contact:
Tara Craig │Email│ 817-250-4960
Location(s):
Texas Health Presbyterian Hospital Dallas
Texas Health Physician Group DallasFunded By:
Medtronic, Inc.
IRB#:
STU-2019-0494
Learn More:
THR: Brief Acceptance-Based Bibliotherapy for Pregnant Women admitted to the Antepartum Unit
Principal Investigator:
Dr. Sadia Omar
Contact:
Dr. Sadia Omar│Email│214-345-5179Location(s):
Texas Health DallasIRB#:
STU-2019-1615
THR: ACURATE IDE
Description:
To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.
Principal Investigator:
Dr. James Park
Contact:
Elizabeth Justus│Email│214-345-3262
Location(s):
Texas Health Presbyterian Hospital Dallas
Funded By:
Boston Scientific Corporation
IRB#:
STU-2020-0251
LIBREXIA - AF
Description:
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
Principal Investigator:
Dr. Martin BerkContact:
Tram Nguyen, R.N. | Email| 214-369-3613Locations:
Texas Health Physicians Group/Texas Health Dallas
Funded By:
Janssen
IRB#:
STU 2023-0138
ClinicalTrials.gov
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
Description:
This is a Phase 2, double-blind, randomized, placebo-controlled, dose-finding, multi-site study to evaluate the safety, efficacy, and dose-response of tovinontrine in adult patients with chronic, stable HFrEF. This study aims to evaluate the safety, tolerability, and percent change from baseline in plasma NT-proBNP at Week 12 across different dose levels of tovinontrine.
Principal Investigator:
Martin Berk, M.D.
Contact:
Tram Nguyen, R.N. | Email| 214-369-3613
Locations:
Texas Health Physicians Group/Texas Health Dallas
Funded By:
Cardurion
IRB#:
STU 2023-0947
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Safety & Effectiveness of Tovinontrine in Patients With Chronic Heart Failure With Preserved Ejection Fraction
Description:
This is a Phase 2, proof-of-concept, double-blind, randomized, placebo-controlled, multicenter study to evaluate the safety and efficacy of tovinontrine, compared with placebo, when administered orally twice daily (BID) for 12 weeks in adult patients with chronic, stable, HFpEF.
Principal Investigator:
Martin Berk, M.D.
Contact:
Tram Nguyen, R.N. | Email| 214-369-3613
Locations:
Texas Health Physicians Group/Texas Health Dallas
Funded By:
Cardurion
IRB#:
STU 2023-0949
Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function (PROTECT IV)
Description:
The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health after a heart procedure compared to the current standard of care.
Principal Investigator:
James Park, M.D.
Contact:
Samantha Bridges, R.N. | Email | 214-345-4387
Locations:
Texas Health Physicians Group/Texas Health Dallas
Funded By:
Abiomed
IRB#:
STU 2021-0596
Use of the Impella ECP™ in Patients Undergoing an Elective or Urgent High-Risk Percutaneous Coronary Intervention
Description:
The Impella ECP Study is a prospective, multi-center, single-arm study evaluating the rate of major adverse cardiovascular and cerebrovascular events (MACCE) with the Impella ECP device in adult patients undergoing elective or urgent high-risk percutaneous coronary intervention.
Principal Investigator:
James Park, M.D.
Contact:
Samantha Bridges, R.N. | Email | 214-345-4387
Locations:
Texas Health Physicians Group/Texas Health Dallas
Funded By:
Abiomed
IRB#:
STU 2022-0397
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation. (APOLLO)
Description
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled will receive the study device.
Principal Investigator:
James Park, M.D.
Contact:
Samantha Bridges, R.N. | Email | 214-345-4387
Locations:
Texas Health Physicians Group/Texas Health Dallas
Funded By:
Metronic
IRB#:
STU 2022-0948
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Tarrant County
Evolut™ EXPAND TAVR II Pivotal Trial
Description:
Multi-center, international, prospective, randomized. Subjects will be randomized on 1:1 basis to Transcatheter Aortic Valve Replacement (TAVR) using the Medtronic Evolut (PRO+ & FX) TAVR system + guideline-directed management and therapy (GDMT) or GDMT alone
Principal Investigator:
Dr. Sukesh Burjonroppa and Dr. Nina Asrani
Contact:
Patricia”Tricia” Snelus, CCRC | Email |817-250-1950
Location(s):
Texas Health Fort Worth
Funded By:
Medtronic
IRB#:
STU-2022-0708
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)
Description:
Lepodisiran has the potential of demonstrating clinically meaningful improvements in cardiovascular disease (CVD) outcomes associated with lowering lipoprotein (a) [Lp(a)]. This study will investigate the effect of lepodisiran on the reduction of major adverse cardiovascular events (MACE) in adults with elevated Lp(a) and established atherosclerotic cardiovascular disease (ASCVD) or who are at risk for a first cardiovascular (CV) event and provide additional evidence for the potential clinical benefits of lepodisiran in this population.
Principal Investigator:
Dr. Tyler Bloomer
Contact:
Tara Craig, RN BSN │ Email │ 817-250-4960
Location:
THPG-Texas Health Heart & Vascular Specialists-Fort Worth
Funded By:
Eli Lilly and Company
IRB#:
STU-2024-0014
THR: SILVIA: SIJ Stabilization in Multilevel Spine Fusion with Fixation to thePelvis: Randomized Controlled Trial
Description:
Based on the rationale for use of iFuse-3D in the Bedrock configuration, the study aims to show that use of this technique reduces the incidence of pelvic hardware failure (primarily S2A1 screw failure/loosening/revision) and the incidence and /or severity of SIJ pain.
Principal Investigator:
Dr. Gregory Smith
Contact:
Dr. Gregory Smith│Email│(817) 820-4280
Location(s):
THPG Fort Worth
Funded By:
SI-Bone, Inc.
IRB#:
STU-2020-0588
PEERLESS II Study
Description:
The FlowTriever System is FDA‐cleared in the United States for the treatment of pulmonary embolism, approved in Canada and Israel, and CE Marked for distribution in Europe.
The FlowTriever Retrieval/Aspiration System is indicated for:
- The non‐surgical removal of emboli and thrombi from blood vessels.
- Injection, infusion, and/or aspiration of contrast media and other fluids into or from
a blood vessel.
The FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.
The study will allow any market cleared anticoagulation medication to be used per local regulations.
The primary study objective is to compare the clinical outcomes of patients treated with the
FlowTriever System plus anticoagulation versus anticoagulation alone for intermediate risk acute pulmonary embolism (PE).
Principal Investigator:
Dr. John Hollingsworth
Contact:
Patricia “Tricia” Snelus, CCRC patriciasnelus@texashealth.org 817-250-1950
Location(s):
Texas Health Fort Worth
Funded By:
Inari Medical
IRB#:
STU-2023-1083
A multicenter, international, randomized, active comparator-controlled, double-blind, parallel group and event driven Phase 3 study of the oral FXIa asundexian (BAY 2433334) for the prevention of ischemic stroke in male and female participants aged 18 years and older after an acute non-cardioembolic ischemic stroke or high-risk TIA (OCEANIC-STROKE)
Description:
Phase 3 study to investigate the efficacy and safety of the oral FXIa inhibitor asundexian (BAY 243334) compared with placebo in participants after an acute non-cardio-embolic ischemic stroke or high-risk TIA
Principal Investigator:
Dr. Claudia Perez
Contact:
Rebecca Wade, RN, BSN rebeccawade@texashealth.org 817-250-4935
Location(s):
Texas Health Fort Worth
Funded By:
Bayer
IRB#:
STU-2023-0497