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This registry is designed to quantify embolic debris capture rate in patients at low surgical risk treated with the Sentinel System during TAVI.
The SENTINEL-LIR Study is a multicenter, prospective registry to observe rate and type of debris capture in subjects at low surgical risk undergoing TAVI to demonstrate the positive effects of the use of the Sentinel System. Histopathology of captured debris from the Sentinel System will be analyzed.
The primary objective is to determine the presence or absence of particles of 7 discreet tissue types: acute thrombus (with or without associated tissue/foreign material), organizing thrombus, valve tissue, arterial wall/necrotic core, calcification, foreign material, and myocardium. Morphometric assessment of the debris (sizes >150 m, >500 m, and >1,000 m).
Patients will be screened for inclusion and exclusion criteria and documents which will have been reviewed and approved by the local Ethics Committee or regulatory authority prior to undergoing any study related exams or procedures.
Fifty (50) subjects will be enrolled in the study from an estimated 6 different sites.
To Determine the Incidence and Type of Debris Capture in SENTINEL Devices Deployed During TAVI in Patients at Low Surgical Risk
Columbia University Medical Center
CVPath Institute Inc.
Published on BioPortfolio: 2019-10-24T12:49:53-0400
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First lymph node to receive drainage from the primary tumor. SENTINEL LYMPH NODE BIOPSY is performed to determine early METASTASIS status because cancer cells may appear first in the sentinel node.
Organisms used to determine measurable environmental risks or hazards to human health and or well-being, thereby serving as advance or early warning signs of impending danger to humans. Examples of sentinel species are monkeys, guinea pigs, and the fabled canary in the coal mine.
A diagnostic procedure used to determine whether LYMPHATIC METASTASIS has occurred. The sentinel lymph node is the first lymph node to receive drainage from a neoplasm.
Monitoring of rate of occurrence of specific conditions to assess the stability or change in health levels of a population. It is also the study of disease rates in a specific cohort, geographic area, population subgroup, etc. to estimate trends in larger population. (From Last, Dictionary of Epidemiology, 2d ed)
A combination of the debris index and the dental calculus index to determine the status of oral hygiene.
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...
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