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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
PULSED AF Post-Approval Study, an Addendum to the PulseSelect™ PFA Global Registry
Description:
PULSED AF PAS is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months.
Principal Investigator:
Dr. Charles Lampe
Contact:
Shelley Long | Email | 972-981-7629
Locations:
THPG-Texas Health Heart and Vascular Specialists- Plano
Funded By:
Medtronic
IRB#:
STU-2024-2987
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Dallas County
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
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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
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
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
EASi-HF A phase III double-blind, randomized, parallel-group superiority trial to evaluate efficacy and safety of the combined use of oral BI 690517 and empagliflozin compared with placebo and empagliflozin in participants with symptomatic heart failure (HF: NYHA II-IV) and left ventricular ejection fraction (LVEF) >=40%
Description:
The goal of the study is to provide substantial evidence of the efficacy, safety, and tolerability of the combination of BI 690517 10mg and empagliflozin 10mg compared with placebo and empagliflozin 10mg on top of standard of care in participants with HF and LVEF >=40%
Principal Investigator:
Dr. Martin Berk
Contact:
Tram Nguyen TramNguyen3@texashealth.org 214-369-3613
Location(s):
THPG-Dallas
Funded By:
Boehringer-Ingelheim
IRB#:
STU-2024-0421
PULSED AF Post-Approval Study, an Addendum to the PulseSelect™ PFA Global Registry
Description:
PULSED AF PAS is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months.
Principal Investigator:
Dr. Charles Lampe
Contact:
Shelley Long | Email | 972-981-7629
Locations:
THPG-Texas Health Heart and Vascular Specialists- Dallas
Funded By:
Medtronic
IRB#:
STU-2024-2987
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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
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
EASi-HF A phase III double-blind, randomized, parallel-group superiority trial to evaluate efficacy and safety of the combined use of oral BI 690517 and empagliflozin compared with placebo and empagliflozin in participants with symptomatic heart failure (HF: NYHA II-IV) and left ventricular ejection fraction (LVEF) >=40%
Description:
The goal of the study is to provide substantial evidence of the efficacy, safety, and tolerability of the combination of BI 690517 10mg and empagliflozin 10mg compared with placebo and empagliflozin 10mg on top of standard of care in participants with HF and LVEF >=40%
Principal Investigator:
Dr. Jainy Savla
Contact:
Tara Craig, RN, BSN TaraCraig@TexasHealth.org 817-250-4960
Location(s):
THPG-Texas Health Heart & Vascular Specialists-Fort Worth
Funded By:
Boehringer-Ingelheim
IRB#:
STU-2024-0802
An early feasibility study of the safety in adult patients with a suspected infection of an artificial knee to be treated with antibiotic therapy and surgical intervention with implant retention followed by a single exposure of the Sola2 AMF Knee System
Description:
This early feasibility study is to collect safety information on the Sola2 AMF Knee System to learn if it can help treat artificial knee infections.
Principal Investigator:
Dr. David Shau
Contact:
Patricia “Tricia” Snelus, CCRC | Email | 817-250-1950
Locations:
Texas Hip and Knee Center
Funded By:
Solenic Medical
IRB#:
2025-0557