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Clinical Trials at TMH

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The following table includes information on current clinical trials available at TMH, which are updated monthly. If you are interested in learning more about clinical trials, please submit the contact form found here

Open Clinical Trials

Cardiology

TMH IRB Number and Trial Name

Trial Title

Additional Information

2018-08, Summit SUMMIT Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation Study Details | Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation | ClinicalTrials.gov 
2020-14, STEMI-DTU Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial Study Details | Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial | ClinicalTrials.gov 
2021-60, Elegance ELEGANCE Drug-ELuting REGistry: ReAl-World Treatment of LesioNs in the Peripheral VasCulaturE Study Details | Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature | ClinicalTrials.gov
2021-80, Alleviate Medtronic ALgorithm using LINQ Sensors for EValuation And TreatmEnt of Heart Failure (ALLEVIATE-HF) Study Details | Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure | ClinicalTrials.gov
2021-97, Expand II Medtronic Evolut EXPAND TAVR II Pivotal Trial Study Details | Evolut™ EXPAND TAVR II Pivotal Trial | ClinicalTrials.gov
2022-02, Aim Higher Assessment of Implantable CCM in the Heart Failure Group with Higher Ejection FRaction Study Details | Assessment of CCM in HF With Higher Ejection Fraction | ClinicalTrials.gov 
2022-05, Cosira II Efficacy of the COronary SInus Reducer in Patients with Refractory Angina II (COSIRA-II) Study Details | Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II | ClinicalTrials.gov
2022-16, EMPOWER TMVR Assessment of the Carillon Mitral Contour System in Treating Heart Failure with Functional Mitral Regurgitation The EMPOWER Trial Study Details | The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR | ClinicalTrials.gov
2023-26, CLASP II Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial (CLASP II TR) Study Details | Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial | ClinicalTrials.gov
2023-32, AFFIRM SPYRAL The SPYRAL AFFIRM Global Clinical Study of Renal Denervation with the Symplicity Spyral Renal Denervation System in Subjects with Uncontrolled Hypertension (SPYRAL AFFIRM) Study Details | SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN | ClinicalTrials.gov
2023-34, Empower CAD Equity in Modifying Plaque Of WomEn with UndeRtreated Calcified Coronary Artery Disease (EMPOWER CAD) Study Details | Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease | ClinicalTrials.gov
2023-46, Magical RCT MagicTouch™ Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions with In-Stent Restenosis The MAGICAL ISR Randomized Clinical Trial Study Details | MagicTouch for Treatment of In-Stent Restenosis in Coronary Artery Lesions | ClinicalTrials.gov
2023-53, PROMISE III Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia: The PROMISE III Trial Study Details | PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia | ClinicalTrials.gov
2023-58, Dal-Gene-2 A phase III, double-blind, randomized placebo-controlled study to evaluate the effects of dalcetrapib on cardiovascular (CV) risk in a genetically defined population with a recent Acute Coronary Syndrome (ACS): The DAL-302 (dal-GenE-2) trial Study Details | Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS | ClinicalTrials.gov
2023-74, AllRise Advancing Cath Lab Results with FFRangio® Coronary Physiology Assessment: The ALL-RISE Study Study Details | Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment | ClinicalTrials.gov
2024-1, Avant Guard A Prospective Randomized Multicenter Global Study Comparing Pulsed Field Ablation versus Anti-Arrhythmic Drug Therapy as a First Line Treatment for Persistent Atrial Fibrillation - AVANT GUARD Study Details | Pulsed Field Ablation (PFA) Versus Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation | ClinicalTrials.gov
2024-10, Symphony PE Evaluation of the Safety and Efficacy of the Symphony Thrombectomy System in the Treatment of Pulmonary Embolism Study Details | SYMPHONY-PE Study for Treatment of Pulmonary Embolism | ClinicalTrials.gov
2024-21, SAVE-FistulaS SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistula Study Study Details | SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study | ClinicalTrials.gov

 

 

Metabolic (Pediatric)

TMH IRB Number and Trial Name  TMH IRB Number and Trial Name Trial Title
2022-64, TrialNet Pathway To Prevention (Protocol TN-01) Study Details | TrialNet Pathway to Prevention of T1D | ClinicalTrials.gov
2024-18, STEP TEENS STEP TEENS Weight Maintenance: A research study on how well semaglutide helps teenagers with excess body weight to lose weight and maintain weight loss Study Details | STEP TEENS Weight Maintenance: A Research Study on How Well Semaglutide Helps Teenagers With Excess Body Weight to Lose Weight and Maintain Weight Loss | ClinicalTrials.gov

Neurosurgery

TMH IRB Number and Trial Name  TMH IRB Number and Trial Name Trial Title
2014-14, Florida Center for Brain Tumor Research Florida Center for Brain Tumor Research Study Details | Florida Center for Brain Tumor Research | ClinicalTrials.gov

Oncology

TMH IRB Number and Trial Name

Trial Title  

Link to Additional Information

2021-44, A191901 OPTIMIZING ENDOCRINE THERAPY THROUGH MOTIVATIONAL INTERVIEWING AND TEXT INTERVENTIONS Study Details | Additional Support Program Via Text Messaging and Telephone-Based Counseling for Breast Cancer Patients Receiving Hormonal Therapy | ClinicalTrials.gov
2022-06, iCaRe2 Integrated Cancer Repository for Cancer Research (iCaRe2) Study Details | Integrated Cancer Repository for Cancer Research | ClinicalTrials.gov
2022-47, CAMBriA-1 CAMBRIA-1: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy with Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients with ER+/HER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence Study Details | A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy | ClinicalTrials.gov
2023-38, R3767-ONC-2236 A RANDOMIZED, DOUBLE-BLIND PHASE 2/3 STUDY OF FIANLIMAB (ANTI-LAG-3 ANTIBODY), CEMIPLIMAB (ANTI-PD-1 ANTIBODY), AND CHEMOTHERAPY VERSUS CEMIPLIMAB AND CHEMOTHERAPY IN FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) IRRESPECTIVE OF PD-L1 EXPRESSION LEVELS Study Details | A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult Patients With Advanced Non-small Cell Lung Cancer | ClinicalTrials.gov
2023-39, A012103 OPTIMICE-PCR: DE-ESCALATION OF THERAPY IN EARLY-STAGE TNBC PATIENTS WHO ACHIEVE PCR AFTER NEOADJUVANT CHEMOTHERAPY WITH CHECKPOINT INHIBITOR THERAPY Study Details | Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab | ClinicalTrials.gov
2024-7, R3767-ONC-2235 A RANDOMIZED, DOUBLE-BLIND PHASE 2/3 STUDY OF FIANLIMAB (ANTI-LAG-3 ANTIBODY) IN COMBINATION WITH CEMIPLIMAB (ANTI-PD-1 ANTIBODY) VERSUS CEMIPLIMAB MONOTHERAPY IN FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED NONSMALL CELL LUNG CANCER (NSCLC) WITH TUMORS EXPRESSING PD-L1 ≥50% Study Details | A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) | ClinicalTrials.gov
2024-8, NRG-CC011 NRG-CC011: COGNITIVE TRAINING FOR CANCER RELATED COGNITIVE IMPAIRMENT IN BREAST CANCER SURVIVORS: A MULTI-CENTER RANDOMIZED DOUBLE- BLINDED CONTROLLED TRIAL Study Details | Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors | ClinicalTrials.gov
2024-15, DIRECT Interim FDG-PET/CT for PreDIcting REsponse of HER2+ Breast Cancer to Neoadjuvant Therapy: DIRECT trial Study Details | Testing the Role of FDG-PET/CT to Predict Response to Therapy Prior to Surgery for HER2-positive Breast Cancer, The DIRECT Trial | ClinicalTrials.gov
2024-24, BNT327-01 A Phase II, multi-site, open-label, parallel group trial of BNT327 in combination with chemotherapy for participants with untreated extensive-stage small-cell lung cancer and participants with previously treated small-cell lung cancer Study Details | Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy | ClinicalTrials.gov