Sylvia Ramos

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Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at L

Jul 2016 - Current (10 years 3 months)

The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR.

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St. Jude Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial

Aug 2015 - Current (11 years 2 months)

The PORTICO clinical trial is a prospective, multi-center, randomized, controlled clinical study, designed to evaluate the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and Delivery Systems (Portico) via transfemoral and alternative delivery methods.

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Corneal and Anterior Segment Optical Coherence Tomography - OptoVue

The objective of the study is to further develop clinical applications for the high speed corneal and anterior segment optical coherence tomography (CAS-OCT) systems developed by Optovue, Inc. (Fremont, CA, USA). The systems are currently designated ACVue and RTVue-CAM (adapted for anterior segment).

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Corneal and Anterior Segment Optical Coherence Tomography for Contact Lens Design

The study involves using corneal optical coherence tomography (OCT) to obtain a better understanding of the anatomy of the eye for contact lens design and to assess the quality of contact lens fit. Particularly in characterizing the difference between Asian and Caucasian eyes

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CHRONIC RETINAL STIMULATION SYSTEM TO PROVIDE ELECTRICAL STIMULATION OF THE RETINA TO ELICIT VISUAL PERCEPTS IN BLIND SU

The objective of this study is to evaluate the safety and efficacy of the retinal electrode by evaluating the data after chronic implantation

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Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa

The objective of this study is to evaluate the safety and efficacy of the retinal stimulation system by evaluating the data after chronic implantation.

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A Multicenter, Double-blind, Randomized, Placebo-controlled Study of Weight-Reduction and/or Low Sodium Diet plus Acetaz

Idiopathic intracranial hypertension (IIH), also called pseudotumor cerebri, is a disorder of elevated intracranial pressure of unknown cause [Corbett, et al., 1982; Wall, et al., 1991]. Its incidence is 22.5 new cases each year per 100,000 overweight women of childbearing age, and is rising [Garrett, et al., 2004] in parallel with the obesity epidemic. It affects about 100,000 Americans. Most patients suffer debilitating headaches. Because of pressure on the optic nerve (papilledema), 86% have some degree of permanent visual loss and 10% develop severe visual loss [Wall, et al., 1991]. Interventions to prevent loss of sight, all with unproven efficacy, include diet, diuretics such as acetazolamide, repeated spinal taps, optic nerve sheath

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Guiding the Treatment of Anterior Eye Diseases with Optical Coherence Tomography

Intraocular Lens Power Calculation After Laser Refractive Surgery Based on Optical Coherence Tomography (OCT IOL)
The long-term goal of this project is to utilize newly available very high-speed optical coherence tomography (OCT) technology to guide surgical treatments of corneal diseases. OCT is well known for its exquisite resolution, but until recently it has not had sufficient speed to capture the shape of the cornea because of eye motion during OCT scanning. The development of Fourier-domain (FD) OCT technology has made the requisite speed possible.

The objective of this project is to develop methods for imaging the cornea with an FD-OCT system that will precisely measure corneal shape and use this information to guide

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Data Collection Study of the Nidek Optical Coherence Tomography RS-3000 for 3D Measurements of the Eye

The purpose of this clinical study is to collect and evaluate the data from eye scans using an investigational three-dimensional eye imaging photography device called the Nidek Optical Coherence Tomography (OCT) RS-3000. OCT stands for Optical Coherence Tomography, a technique that uses invisible wavelengths of light to make detailed images of the tissues at the back of the eye. These images provide information that physicians may use to help diagnose eye conditions and/or to monitor changes in the eye during treatment.

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Argus® II Retinal Stimulation System Feasibility Protocol

The objective of this feasibility study is to evaluate the safety and utility of the Argus II Retinal Stimulation System in providing visual function to blind subjects with severe to profound retinitis pigmentosa.

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Advanced Imaging for Glaucoma Study (AIGS)

Project Manager Coordinating Center and Chairman's Office. The purpose of the study is to predict the development of glaucomatous visual field (VF) abnormality in glaucoma suspects and pre-perimetric glaucoma patients based on anatomic abnormalities detected by advanced imaging. Predict the development of glaucomatous VF abnormality in glaucoma suspects and pre-perimetric glaucoma patients based on anatomic changes detected between successive advanced imaging tests. Determine the sensitivity and specificity of glaucoma diagnosis based on advanced imaging tests.

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Retrospective review of corneal and anterior segment surgical and pathological cases on the Visante Optical Coherence To

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Neuroprotection in Patients Undergoing Aortic Valve Replacement

To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).

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WATS3D (Wide Area Transepithelial Sample Biopsy with 3-Dimensional Computer-Assisted Analysis) and Biopsy Forceps for De

The objective of this study is to collect data from patients undergoing esophagogastroduodenoscopy (EGD) with a combination of targeted forceps biopsy, WATS3D biopsy, and Seattle protocol random forceps biopsy. Long term follow up to refine our current knowledge regarding the true progression rate from Barrett’s esophagus to low grade dysplasia and form low grade dysplasia to high grade dysplasia and esophageal cancer.

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Topcon OCT Reference Database

To collect OCT measurement data on normal healthy eyes in order to determine the reference limits for Topcon 3D OCT-1 Maestro and for Topcon 3D OCT-2000.

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Medtronic CoreValve® U.S. Expanded Use Study

The primary objective of the study is to evaluate the safety and effectiveness of the Medtronic CoreValve® System (MCS) in a subset of subjects excluded from the U.S. Extreme Risk Pivotal Trial population due to one or more additional co-morbidities, as measured by a composite of all-cause death or major stroke at 12 months, in the treatment of symptomatic severe aortic stenosis in subjects necessitating aortic valve replacement. Subjects enrolled in this study have a predicted operative mortality or serious, irreversible morbidity risk of ≥50% at 30 days associated with surgical aortic valve replacement.

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Repository for Inherited Eye Diseases

This study will collect blood and DNA samples from patients with inherited eye diseases to be used in research to identify genetic factors responsible for these conditions. In recent years, nearly 500 genes that contribute to inherited eye diseases have been identified. Disease-causing mutations are associated with many eye diseases, including glaucoma, cataracts, strabismus, corneal dystrophies and a number of forms of retinal degenerations. As a result, gene-based therapies are being pursued to treat eye genetic diseases that were once considered untreatable.

The National Ophthalmic Genotyping Network (eyeGENE ) is creating a national tissue repository to further advance genetic research on inherited eye disease, while at the s

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Tear Collection and Analysis in Patient with Dry Eyes and Sjögren’s Syndrome

The objective of this study is to explore the possibility of using biomarkers from tear samples as a predictive marker of disease. .

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Medtronic CoreValve Evolut R U.S. Clinical Study

The study objectives are to assess the safety and efficacy of the CoreValve Evolut R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis are considered at high or extreme risk for surgical aortic valve replacement.

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Rate Control versus Rhythm Control for Post-Operative Atrial Fibrillation

The purpose of this study is to compare the therapeutic strategies of rate control versus rhythm control in cardiac surgery patients who develop in-hospital postoperative atrial fibrillation or atrial flutter (AF). In patients who develop AF during hospitalization after cardiac surgery, the hypothesis is that a strategy of rhythm control will reduce days in hospital within 60 days of the occurrence of AF compared to a strategy of rate control.

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NinePoint High Resolution Optical Imaging of Esophageal Tissue Using the Nvision VLE Imaging System Registry

This is a prospective, multi-site registry with longitudinal follow up for patients undergoing esophagogastroduodenoscopy (EGD) or endoscopy. The primary objective is to provide a collection of patient NvisionVLE™ procedural data for participating physicians, including, but not limited to, imaging data, clinical utility data, demographics, pathology, treatment, and surveillance.

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Safety & Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients

The main purpose of this research is to determine whether injecting mesenchymal precursor cells (MPC) into the heart during surgery to implant a left ventricular assist device (LVAD) is safe. MPCs are normally present in human bone marrow and have been shown to increase the development of blood vessels and new heart muscle cells in the heart. In addition, this research is being done to test whether injecting the MPCs into the heart is effective in improving heart function.

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A Phase 3, Randomized, Placebo-Controlled Study of Lenzilumab in Hospitalized Patients with COVID-19 Pneumonia

Jul 2020 - Oct 2020 (4 months)

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A Phase 3, Randomized, Placebo-Controlled Study of Lenzilumab in Hospitalized Patients with COVID-19 Pneumonia

Jul 2020 - Oct 2020 (4 months)

To assess whether the use of lenzilumab in addition to current standard of care (SOC) can alleviate the immune-mediated cytokine release syndrome (CRS) and prevent progression to respiratory failure and/or death in high risk patients with COVID-19 pneumonia

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Retrospective Study of Surgical Complications in Patients with Defunctioning Stoma After Low Anterior Resection for Rect

May 2020 - Oct 2020 (6 months)

Co-Coordinator

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ARISE: Evaluation of the GORE Ascending Stent Graft in the Treatment of DeBakey Type I/II Dissection

Dec 2019 - Oct 2020 (11 months)

Primary Research Coordinator

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Target-CR0002-Ablative

Sep 2019 - Oct 2020 (1 year 2 months)

Primary Research Coordinator - Unmasked

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Epifix Vs. Control in the Treatment of Partial Thickness Burns

Aug 2019

To determine the safety and effectiveness of EpiFix® plus Control (Mepilex ® Ag) as compared to Control alone for the treatment of second degree burns as assessed by time to healing and scarring.

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Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Parare

Apr 2019 - Oct 2020 (1 year 7 months)

Primary Research Coordinator

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RelayPro Thoracic Stent-Graft in Subjects with Acute, Complicated Type B Aortic Dissections

Nov 2018 - Oct 2020 (2 years)

Back up Research Coordinator

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RelayPro Thoracic Stent-Graft in Subjects with Traumatic Injury of the Descending Thoracic Aorta

Nov 2018 - Oct 2020 (2 years)

Primary Research Coordinator

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Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch

Aug 2017 - Oct 2020 (3 years 3 months)

Primary Research Coordinator

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The RE-ENERGIZE Study: RandomizEd Trial of ENtERal Glutamine to minimIZE Thermal Injury (RE-ENERGIZE)

Aug 2016 - Oct 2020 (4 years 3 months)

Back up Coordinator

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CALIBER-Randomized Controlled Trial of LINX versus Double-Dose Proton Pump Inhibitor Therapy for Reflex Disease

Jul 2015

This study compares mechanical sphincter augmentation (LINX Reflux Management System) to double-dose proton pump inhibitors (PPIs) for the management of reflux symptoms related to gastroesophageal reflux disease (GERD).

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CREST-2 Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis

May 2015 - Oct 2020 (5 years 6 months)

Primary Research Coordinator

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Atricure Synergy Ablation Lesions for Non-Paroxysmal Forms of Atrial Fibrillation Treatment During Concomitant On-Pump E

Oct 2014 - Jan 2018 (3 years 4 months)

The primary objective of this post-approval study is to evaluate the clinical outcomes in a cohort of patients with non-paroxysmal forms of atrial fibrillation (persistent or long-standing persistent) treated during commercial use of the AtriCure Synergy Ablation System by physicians performed the Maze IV procedure.

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Sylvia Ramos

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Behavioral traits