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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
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
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
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
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
EASi-HF reduced – A Phase III double-blind, randomized, parallel-group superiority trial to evaluate efficacy and safety of the combined use of oral vicadrostat (BI 690517) and empagliflozin compared with placebo and empagliflozin in participants with symptomatic chronic heart failure (HF: NYHA II-IV) and left ventricular ejection fraction (LVEF) < 40%
Description:
This trial aims to determine if an investigational new treatment option that combines vicadrostat and empagliflozin is effective and safe for people who have heart failure and an LVEF of less than 40%.
Principal Investigator:
Dr. Jainy Savla
Contact:
Tara Craig, RN BSN | Email | 817-250-4960
Locations:
THPG-Texas Health Heart & Vascular Specialists-Fort Worth
Funded By:
Boehringer-Ingelheim
IRB#:
STU-2025-1190