The objective of this study is to compare the safety and effectiveness of the Route 92 Medical Reperfusion System to predicate AXS Vecta Aspiration System.
The purpose of this study is to see if the study drug, elezanumab, is safe and able to improve cognitive and/or motor functioning in an individual following the occurrence of acute ischemic stroke. This is a 52-week, Phase 2a, randomized, double-blind, parallel-group, placebo-controlled, multicenter proof-of concept study.
The objective of this study is to investigate whether percutaneous PFO closure with the Occlutech Flex II PFO Occluder is non-inferior to the AMPLATZER™ PFO Occluder and Gore® Cardioform Septal Occluder in closure of the PFO, prevention of recurrent embolic stroke, and device/procedure related Serious Adverse Events (SAE)
The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.
Abbott developed the AMPLATZER™ PFO Occluder as a minimally invasive, transcatheter PFO closure treatment to further reduce the risk of recurrent stroke among patients with PFO and cryptogenic stroke beyond that achieved with medical management. This additional risk reduction is achieved by blocking the pathway for a venous embolism from reaching the body's arterial system and the brain.
ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. Eleven hundred subjects will be recruited over 2.5 years at 120 sites in the NIH StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 4 years for the primary efficacy outcome of recurrent stroke and the primary safety outcomes of symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage.
The purpose of this research study is to explore the challenges of recognizing stroke in young adults, the process of making treatment decisions, and the patient’s understanding of the risk of recurrence and long term consequences of stroke. This study consists of a 30 to 60 minute interview of patients with prior stroke (ischemic stroke, transient ischemic attack, or intracerebral hemorrhage) who were 18-50 years of age at the time of stroke onset.
This is a global, multi-center, noninterventional study that will collect data on patients with PD under standard-of-care treatment according to local routine clinical practice. The primary objective of the study is to assess the impact of the frequency of assessments on the variability over time, reliability, and compliance for the PD diary in patients with PD in whom medications do not provide adequate control of symptoms.
The purpose of the study is to evaluate whether LYS228 can be developed for the treatment of complicated urinary tract infections
Aortic stenosis (AS) affects over 12.6 million adults and causes an estimated 102,700 deaths annually. There is interest in novel approaches to identify valve disease earlier the disease course before symptoms occur. We previously used machine learning (ML) to develop a system for fully automated AS screening. Here we are validating the performance of this new method for identifying AS.
To determine whether these contributions of the Mineralocorticoid Receptor to vascular function and disease determined in animal models are also implicated in human vessels and to address the impact of sex, age, cardiovascular risk factors, and potentially race, which cannot be completely recapitulated in vitro or in mouse models.
This study will evaluate infant vision health based on the history of prenatal drug exposure. Data from this study will be used to create a new process which will include vision health as part of the discharge planning for infants with prenatal drug exposure admitted to Tufts Children’s Hospital
This is an observational study to assess the the burden of neuropathic involvement in wild-type transthyretin amyloidosis
To evaluate the efficacy and safety of Botulinum Toxin Type A PUrified Neurotoxin Complex (BOTOX) compared to placebo for the treatment of upper limb essential tremor.
The primary objective for this early feasibility study is to assess safety and feasibility of the Impella ECP device in adult patients undergoing an elective high-risk percutaneous coronary intervention. To assess safety, special attention is being paid to the effect of the pump on the aortic valve
This study is designed to evaluate the safety and efficacy of sotatercept versus placebo in adults with Cpc-PH due to HFpEF.
This is a Phase 1/2a, nonrandomized, open-label, parallel assignment, dose-escalation, and dose-optimization study to evaluate the safety and clinical activity of PBCAR0191 in adults with r/r B ALL (Cohort A) and in adults with r/r B-cell NHL (Cohort N) and identify a treatment regimen most likely to result in clinical efficacy while maintaining a favorable safety profile.
This is a Prospective, multicenter, randomized, parallel-controlled, open-label two arm trial with an adaptive design. Eligible subjects will be randomized in a 1:1 ratio to PCI with Impella CP® (Intervention Group) versus standard of care PCI with or without IABP (Control Group). Approximately 1252 subjects will be randomized in a 1:1 ratio to PCI + Impella vs. PCI ± IABP.
The purpose of this randomized study is to evaluate the safety and effectiveness of EVAHEART 2 Implantable Left Ventricular Assist System (EVA2 LVAS) by demonstrating non-inferiority to HeartMate 3 when used for the treatment of advanced, refractory, New York Heart Association Class IV heart failure.
Cardiogenic shock (CS) is a dangerous clinical condition where the heart’s ability to pump blood is so compromised that it cannot support the vital functions of the rest of the body. CS has an increased risk of death of 50-60%, and despite tremendous research effort over the last decade, survival outcomes have not changed over this period. Current treatment for CS often involves mechanical circulatory support (MCS) devices, which are mechanical pumps that help support blood flow to the body.
