Search Clinical Trials
Below please find a list of studies actively recruiting volunteers at one of the following GHUCCTS institutions: Georgetown University, Howard University, MedStar Health Research Institute, or Washington DC VA Medical Center. Please enter your search criteria below to help find a study for you. If you have any questions, please email us or call us at 301-560-2963.
Study is registered in ResearchMatch Sponsor Condition of Interest |
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Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence
Women and Infants Hospital of Rhode Island
Urgency Urinary Incontinence
The goal of this clinical trial is to compare treatment outcomes between an oral
medication (beta agonist) versus onabotulinumtoxinA injections in women with urgency
urinary incontinence (UUI).
Participants will be randomly selected to receive one of the two treatments. The primary
outcome measure... expand
The goal of this clinical trial is to compare treatment outcomes between an oral medication (beta agonist) versus onabotulinumtoxinA injections in women with urgency urinary incontinence (UUI). Participants will be randomly selected to receive one of the two treatments. The primary outcome measure will be at 3 months, and women will be followed for a total of 12 months. Based on patient expert input, there are 2 primary outcomes: Treatment satisfaction and urinary symptom severity. Type: Interventional Start Date: Jun 2023 |
Immunization With BCG Vaccine to Prevent Tuberculosis Infection
Henry M. Jackson Foundation for the Advancement of Military Medicine
Tuberculosis Infection
The purpose of this research is to find out if a single dose of pre-travel vaccination
with BCG can lessen tuberculosis (TB) infection by producing an immune response when
given to adults traveling to countries with a high burden of TB. BCG will be compared
with a placebo (an inactive vaccine). BCG... expand
The purpose of this research is to find out if a single dose of pre-travel vaccination with BCG can lessen tuberculosis (TB) infection by producing an immune response when given to adults traveling to countries with a high burden of TB. BCG will be compared with a placebo (an inactive vaccine). BCG (Japan) is used globally but is not approved for use in the United States, therefore it is considered experimental. Participants choosing to take part in this research study, will be randomly assigned (this is like a coin flip) to BCG or placebo. 2000 eligible volunteers will be enrolled. Type: Interventional Start Date: Dec 2021 |
Metformin in Alzheimer's Dementia Prevention
Columbia University
Mild Cognitive Impairment
MAP will be a multisite phase II/III 1:1 randomized controlled trial (RCT) of long acting
metformin (reduced mass Glucophage XR) vs. matching placebo in 326 men and women with
early and late aMCI, without diabetes, not treated with metformin, overweight or obese,
aged 55 years to 90 years. The RCT... expand
MAP will be a multisite phase II/III 1:1 randomized controlled trial (RCT) of long acting metformin (reduced mass Glucophage XR) vs. matching placebo in 326 men and women with early and late aMCI, without diabetes, not treated with metformin, overweight or obese, aged 55 years to 90 years. The RCT will last 18 months and have 4 visits: baseline, 6-months, 12-months, and 18-months. The RCT will be preceded by a screening phase followed by randomization and a titration period in which drug/placebo will be titrated from 500 mg a day (one tablet) to 2,000 mg a day (4 tablets), in increments of 500 mg (one tablet) every 10 days. Participants will remain in the RCT on the tolerated dose, and included in analyses on an intent to treat basis. We expect the attrition rate to be 10%/year. Neuropsychological battery, clinical interviews, physical exam, and phlebotomy will be conducted at baseline and every 6 months. Brain MRI will be conducted in approximately half of the participants (186) twice, at baseline, and after the last study visit at month 18. We will also conduct brain amyloid Positron Emission Tomography (PET) using 18F-Florbetaben, and tau PET using 18F-MK6240 in half of the participants at baseline and end of the RCT. The primary clinical outcome of the study will be changes in the Free and Cued Selective Reminding Test. The secondary clinical outcome will be changes in the Alzheimer's Disease Cooperative Study Preclinical Alzheimer's Cognitive Composite. Secondary subclinical outcomes will be changes in cortical thickness AD signature areas, changes in white matter hyperintensity volume, changes in brain amyloid burden, changes in brain tau burden, and changes in plasma biomarkers of amyloid, tau, and neurodegeneration. The data coordinating center and Imaging Core is located at John Hopkins University. The PET coordinating center is located at UC-Berkeley. The Clinical Coordinating and Monitoring Center and the central laboratory will be located at Columbia. The Research pharmacy function will be shared by the University of Rochester, which will dispense randomization kits, and the University of Iowa, which will receive bulk metformin and identical matching placebo from EMD Serono. Type: Interventional Start Date: Mar 2021 |
AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants...
Eisai Inc.
Preclinical Alzheimer's Disease
Early Preclinical Alzheimer's Disease
The primary purpose of this study is to determine whether treatment with lecanemab is
superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive
Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether
treatment with lecanemab is superior to placebo... expand
The primary purpose of this study is to determine whether treatment with lecanemab is superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with lecanemab is superior to placebo in reducing brain amyloid accumulation as measured by amyloid positron emission tomography (PET) at 216 weeks of treatment (A3 Trial). This study will also evaluate the long-term safety and tolerability of lecanemab in participants enrolled in the Extension Phase. Type: Interventional Start Date: Jul 2020 |
The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Renal Function in Adults Living...
Eli Lilly and Company
Overweight and Obesity
The main purpose of this study is to determine if retatrutide can significantly lower the
incidence of serious heart-related complications or prevent the worsening of kidney
function. The trial will enroll adults with body mass index 27 kg/m^2 or higher and
Atherosclerotic Cardiovascular Disease and/or... expand
The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function. The trial will enroll adults with body mass index 27 kg/m^2 or higher and Atherosclerotic Cardiovascular Disease and/or chronic kidney disease. The study will last for about 5 years. Participants will have up to 27 clinic visits with the study doctor. Type: Interventional Start Date: Apr 2024 |
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide...
Novo Nordisk A/S
Type 2 Diabetes
This study will look at how well CagriSema helps people with type 2 diabetes lower their
blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not
yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide that
doctors may prescribe in some... expand
This study will look at how well CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide that doctors may prescribe in some countries. Participants will get either CagriSema or tirzepatide. Which treatment participant get is decided by chance like flipping a coin. Participant will have an equal chance of receiving either drug. For each participant, the study will last for up to one and a half years. Type: Interventional Start Date: Jan 2024 |
A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor),...
Hoffmann-La Roche
Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
This is a Phase III, randomized, open-label multicenter study that will evaluate the
efficacy and safety of giredestrant compared with fulvestrant, both in combination with
the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib),
in participants with estrogen receptor-positive... expand
This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy. Type: Interventional Start Date: Dec 2023 |
Daratumumab for Polyneuropathy Associated With MGUS
Georgetown University
Peripheral Neuropathy
Monoclonal Gammopathy of Undetermined Significance
The goal of this clinical trial is to learn about daratumumab and hyaluronidase-fihj in
patients with monoclonal gammopathy of undetermined significant (MGUS) who have been
diagnosed with peripheral neuropathy suspected to be cause by paraproteinemia. The main
question[s] it aims to answer are:
•... expand
The goal of this clinical trial is to learn about daratumumab and hyaluronidase-fihj in patients with monoclonal gammopathy of undetermined significant (MGUS) who have been diagnosed with peripheral neuropathy suspected to be cause by paraproteinemia. The main question[s] it aims to answer are: • how well does this medication help improve MGUS associated peripheral neuropathy Participants will be asked be asked to get some testing done prior to starting the trial in order for us to assess your nerve damage or peripheral neuropathy. This will include blood tests, a complete neurologic examination, surveys and tests called electromyogram and nerve conduction studies. Participants that qualify for the trial will take DARZALEX FASPRO® once a week for two months, followed by every other week from months 3 to month 6. Type: Interventional Start Date: Aug 2024 |
Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation
Eledon Pharmaceuticals
Kidney Transplant Rejection
This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in
patients undergoing kidney transplantation. expand
This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation. Type: Interventional Start Date: Aug 2023 |
Direct Access Carotid Artery Stenting Using the Neuroguard IEP System (PERFORMANCE III)
Contego Medical, Inc.
Carotid Stenosis
Carotid Artery Diseases
The PERFORMANCE III study is a prospective, multicenter single-arm, open label study to
evaluate the safety and effectiveness of the Neuroguard IEP® Direct System for the
treatment of carotid artery stenosis in subjects at elevated risk for carotid
endarterectomy (CEA).
Eligible patients greater... expand
The PERFORMANCE III study is a prospective, multicenter single-arm, open label study to evaluate the safety and effectiveness of the Neuroguard IEP® Direct System for the treatment of carotid artery stenosis in subjects at elevated risk for carotid endarterectomy (CEA). Eligible patients greater than or equal to 20 years of age and less than or equal to 80 years of age, are those who have been diagnosed with either de-novo atherosclerotic or post CEA restenotic lesion(s) in the internal carotid arteries (ICA) or at the carotid bifurcation with greater than or equal to 50% stenosis if symptomatic or greater than or equal to 70% stenosis if asymptomatic. Type: Interventional Start Date: Oct 2023 |
Strategies and Treatments for Respiratory Infections &Amp; Viral Emergencies (STRIVE): Immune Modulation...
University of Minnesota
COVID-19
COVID-19 can trigger a dysregulated immune response, and previous studies have shown that
immune modulation can improve outcomes in hospitalized patients. This trial is designed
to determine whether intensification of immune modulation early in the course of the
disease (while patients are on low... expand
COVID-19 can trigger a dysregulated immune response, and previous studies have shown that immune modulation can improve outcomes in hospitalized patients. This trial is designed to determine whether intensification of immune modulation early in the course of the disease (while patients are on low flow oxygen) with abatacept (active arm) combined with standard of care (SOC) improves recovery as compared with placebo + SOC (placebo arm). For both groups, intensification of immunomodulation will be provided as part of SOC in case of signs of disease progression (patient requires high flow nasal oxygen (HFNO) or more support) and/or if the patient has rapidly increasing oxygen requirement. Type: Interventional Start Date: Jul 2023 |
Safety, Tolerability and Efficacy of AntiBKV as Treatment of BKV Infection in Kidney Transplant Recipients
Memo Therapeutics AG
BK Viremia; BKV DNAemia
The purpose of this study is to evaluate the safety, tolerability, and efficacy of
AntiBKV in reducing BKV DNAemia and progression to biopsy-confirmed BKVAN in kidney
transplant recipients. This study has an operationally seamless phase II/III design. The
phase II part will evaluate the safety of... expand
The purpose of this study is to evaluate the safety, tolerability, and efficacy of AntiBKV in reducing BKV DNAemia and progression to biopsy-confirmed BKVAN in kidney transplant recipients. This study has an operationally seamless phase II/III design. The phase II part will evaluate the safety of AntiBKV in kidney transplant recipients and establish antiviral proof of concept. The phase II part includes a dose-comparison part to generate additional PK and PD data of AntiBKV. The phase III part will assess the efficacy of AntiBKV in kidney transplant recipients. For both the phase II and phase III parts, participants will be randomized to receive either four doses of AntiBKV or four doses of placebo (every four weeks). In phase II, 60 participants will be first randomized (1:1) to receive either four doses of 1,000 mg of AntiBKV or placebo. In an additional dose-comparison extension, another 30 participants will be enrolled and randomized (1:1:1) to receive either four doses of 1,000 mg AntiBKV, four doses of 500 mg AntiBKV, or placebo. Based on a Day 141 analysis after phase II the sample size for the phase III part of the trial will be defined. Both the phase II and phase III parts will follow identical study assessments and schedules for participants. Eligible participants will receive an intravenous infusion of the investigational medicinal product (IMP) that will be administered four times at a four-week interval. For the first ten participants enrolled in the study, the infusion time will be at least 60 minutes. Provided there are no safety concerns observed with the first ten participants the duration of subsequent infusions will be at least 30 minutes. After administration of the final dose, participants will return as out participants for periodic safety, BKV DNAemia, and PK follow-up assessments until the end of the trial visits, 26 weeks post last IMP application. Regular kidney biopsies will be performed at baseline (prior to infusion) and on Day 141 (8 weeks after full dosing). An additional biopsy will be taken on Day 267 (optional) and if clinically indicated. Type: Interventional Start Date: Apr 2023 |
Alzheimer's Disease Neuroimaging Initiative 4
University of Southern California
Mild Cognitive Impairment
Alzheimer Disease
Dementia
Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging
Initiative (ADNI) Study has been to validate biomarkers for Alzheimer's disease (AD)
clinical trials. ADNI4 continues the previously funded ADNI1, ADNI-GO, ADNI2, and ADNI3
studies that have combined public/private... expand
Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) Study has been to validate biomarkers for Alzheimer's disease (AD) clinical trials. ADNI4 continues the previously funded ADNI1, ADNI-GO, ADNI2, and ADNI3 studies that have combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of AD. Type: Observational Start Date: Jun 2023 |
A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents With Nonsegmental Vitiligo (Active...
Pfizer
Stable Nonsegmental Vitiligo
Active Nonsegmental Vitiligo
A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents with Nonsegmental
Vitiligo (Active and Stable) Tranquillo expand
A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents with Nonsegmental Vitiligo (Active and Stable) Tranquillo Type: Interventional Start Date: Dec 2022 |
A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active...
argenx
Active Idiopathic Inflammatory Myopathy
Myositis
Dermatomyositis
Polymyositis
Immune-Mediated Necrotizing Myopathy
This study's purpose is to measure the treatment response from efgartigimod PH20 SC
compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM).
Participants with the IIM subtypes of dermatomyositis (DM), immune-mediated necrotizing
myopathy (IMNM), or certain other subtypes... expand
This study's purpose is to measure the treatment response from efgartigimod PH20 SC compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM). Participants with the IIM subtypes of dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), or certain other subtypes of polymyositis (PM; including antisynthetase syndrome [ASyS]) will be included in the study. Treatment response will be measured by Total improvement score (TIS). Additional information can be found on https://myositis-study.com/. Type: Interventional Start Date: Oct 2022 |
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients...
Hoffmann-La Roche
Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
The main objective of the study is to evaluate the efficacy of satralizumab compared with
placebo based on time from randomization to the first occurrence of an adjudicated MOGAD
relapse in the double-blind (DB) treatment period expand
The main objective of the study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period Type: Interventional Start Date: Aug 2022 |
Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis...
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Diffuse Cutaneous Systemic Sclerosis
Interstitial Lung Disease
The purpose of this study is to assess the safety and efficacy of tulisokibart in
participants with SSc-ILD. expand
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD. Type: Interventional Start Date: Jul 2022 |
A Study to Evaluate Sapablursen (Formerly ISIS 702843, IONIS-TMPRSS6-LRx) in Patients With Polycythemia...
Ionis Pharmaceuticals, Inc.
Phlebotomy Dependent Polycythemia Vera
The main purpose of this study is to evaluate the efficacy of sapablursen in reducing the
frequency of phlebotomy and in improving quality of life assessments in participants with
polycythemia vera. expand
The main purpose of this study is to evaluate the efficacy of sapablursen in reducing the frequency of phlebotomy and in improving quality of life assessments in participants with polycythemia vera. Type: Interventional Start Date: Dec 2021 |
Testing if High Dose Radiation Only to the Sites of Brain Cancer Compared to Whole Brain Radiation That...
NRG Oncology
Metastatic Lung Small Cell Carcinoma
Metastatic Malignant Neoplasm in the Brain
Recurrent Lung Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8
Stage IVA Lung Cancer AJCC v8
This phase III trial compares the effect of stereotactic radiosurgery to standard of care
memantine and whole brain radiation therapy that avoids the hippocampus (the memory zone
of the brain) for the treatment of small cell lung cancer that has spread to the brain.
Stereotactic radiosurgery is a... expand
This phase III trial compares the effect of stereotactic radiosurgery to standard of care memantine and whole brain radiation therapy that avoids the hippocampus (the memory zone of the brain) for the treatment of small cell lung cancer that has spread to the brain. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Whole brain radiation therapy delivers a low dose of radiation to the entire brain including the normal brain tissue. Hippocampal avoidance during whole-brain radiation therapy (HA-WBRT) decreases the amount of radiation that is delivered to the hippocampus which is a brain structure that is important for memory. The drug, memantine, is also often given with whole brain radiotherapy because it may decrease the risk of side effects related to thinking and memory. Stereotactic radiosurgery may decrease side effects related to memory and thinking compared to standard of care HA-WBRT plus memantine. Type: Interventional Start Date: Jun 2021 |
Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without...
VA Office of Research and Development
Prostate Cancer
Oligometastasis
Oligorecurrence
Recurrent Prostate Cancer
Metastatic Prostate Cancer
This is a prospective, open-label, multi-center seamless phase II to phase III randomized
clinical trial designed to compare SST with or without PET-directed local therapy in
improving the castration-resistant prostate cancer-free survival (CRPC-free survival) for
Veterans with oligometastatic prostate... expand
This is a prospective, open-label, multi-center seamless phase II to phase III randomized clinical trial designed to compare SST with or without PET-directed local therapy in improving the castration-resistant prostate cancer-free survival (CRPC-free survival) for Veterans with oligometastatic prostate cancer. Oligometastasis will be defined as 1-10 sites of metastatic disease based on the clinical determination of the LSI which incorporates all imaging, clinical, and pathologic data available. Type: Interventional Start Date: Jul 2021 |
Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
United Therapeutics
Idiopathic Pulmonary Fibrosis
Interstitial Lung Disease
Study RIN-PF-301 is designed to evaluate the superiority of inhaled treprostinil against
placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52. expand
Study RIN-PF-301 is designed to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52. Type: Interventional Start Date: Jun 2021 |
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching...
Mirum Pharmaceuticals, Inc.
Primary Sclerosing Cholangitis
The purpose of this clinical research study is to learn more about the use of the study
medicine, volixibat, for the treatment of pruritus (itching) associated with Primary
Sclerosing Cholangitis (PSC), and to assess the possible impact on the disease
progression of PSC. expand
The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Sclerosing Cholangitis (PSC), and to assess the possible impact on the disease progression of PSC. Type: Interventional Start Date: Dec 2020 |
A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer
Alliance Foundation Trials, LLC.
Endometrial Cancer
This is a Phase IB/II multi-cohort study designed to evaluate the efficacy and safety of
targeted agents with or without cancer immune checkpoint therapy with atezolizumab in
participant with recurrent and/or persistent endometrial cancer. The main protocol
provides a platform for genomic screening... expand
This is a Phase IB/II multi-cohort study designed to evaluate the efficacy and safety of targeted agents with or without cancer immune checkpoint therapy with atezolizumab in participant with recurrent and/or persistent endometrial cancer. The main protocol provides a platform for genomic screening with homogeneous basic eligibility criteria in order to direct study participants into biomarker-matched study cohorts consisting of testing targeted agents. Type: Interventional Start Date: Oct 2021 |
ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
American Thrombosis and Hemostasis Network
Hematologic Disorder
Bleeding Disorder
Connective Tissue Disorder
Hemophilia
Thrombosis
In parallel with the growth of American Thrombosis and Hemostasis Network's (ATHN)
clinical studies, the number of new therapies for all congenital and acquired hematologic
conditions, not just those for bleeding and clotting disorders, is increasing
significantly. Some of the recently FDA-approved... expand
In parallel with the growth of American Thrombosis and Hemostasis Network's (ATHN) clinical studies, the number of new therapies for all congenital and acquired hematologic conditions, not just those for bleeding and clotting disorders, is increasing significantly. Some of the recently FDA-approved therapies for congenital and acquired hematologic conditions have yet to demonstrate long-term safety and effectiveness beyond the pivotal trials that led to their approval. In addition, results from well-controlled, pivotal studies often cannot be replicated once a therapy has been approved for general use.(1,2,3,4) In 2019 alone, the United States Food and Drug Administration (FDA) has issued approvals for twenty-four new therapies for congenital and acquired hematologic conditions.(5) In addition, almost 10,000 new studies for hematologic diseases are currently registered on www.clinicaltrials.gov.(6) With this increase in potential new therapies on the horizon, it is imperative that clinicians and clinical researchers in the field of non-neoplastic hematology have a uniform, secure, unbiased, and enduring method to collect long-term safety and efficacy data. ATHN Transcends is a cohort study to determine the safety, effectiveness, and practice of therapies used in the treatment of participants with congenital or acquired non-neoplastic blood disorders and connective tissue disorders with bleeding tendency. The study consists of 7 cohorts with additional study "arms" and "modules" branching off from the cohorts. The overarching objective of this longitudinal, observational study is to characterize the safety, effectiveness and practice of treatments for all people with congenital and acquired hematologic disorders in the US. As emphasized in a recently published review, accurate, uniform and quality national data collection is critical in clinical research, particularly for longitudinal cohort studies covering a lifetime of biologic risk.(7) Type: Observational Start Date: Sep 2020 |
Amplatzer Amulet LAAO vs. NOAC
Abbott Medical Devices
Atrial Fibrillation
Stroke
Bleeding
The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA
occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for
ischemic stroke and who are recommended for long-term NOAC therapy.
The clinical investigation is a prospective, randomized,... expand
The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy. The clinical investigation is a prospective, randomized, multicenter active control worldwide trial. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device ("Device Group") and a commercially available NOAC medication ("Control Group"). The choice of NOAC in the Control Group will be left to study physician discretion. Type: Interventional Start Date: Jul 2020 |