Severe Symptomatic Aortic Stenosis Clinical Trial
— TAVR-NeuroOfficial title:
Assessment of Neurologic Injury Subsequent to Transcatheter Aortic Valve Replacement: A Feasibility Study
Verified date | October 2016 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
The investigators seek to determine the feasibility of assessing neurologic injuries subsequent to transcathether aortic valve replacement (TAVR). Such a model has been applied previously by the principal investigator to assess and improve neurologic outcomes for other cardiac surgical procedures. The investigators shall assess patients during the following intervals: pre-procedure, within 72-96 hours post-procedure, and 3 months post-procedure. Case videos will be established to assist in identifying and associating emboli (using transcranial Doppler) and processes of clinical care during the TAVR procedure. Neurologic injury will be assessed in the following ways: stroke (neurologic exam, NIH Stroke Scale), silent infarcts (diffusion-weighted MRI, diffusion-tensor imaging), and neurobehavioral deficits (a battery of neuropsychological tests). Secondly, the investigators will investigate changes in the apnea-hypopnea index (AHI), a measure of sleep-disordered breathing, before vs after surgery between those subjects who develop post-operative acute brain infarction and those who do not. The investigators hypothesize that subjects who develop acute brain infarction will have an increase in AHI between baseline and post-op measurements compared with those subjects who do not develop acute brain infarction. A research coordinator will coordinate the testing.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 2017 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Adults > age 18 years old 2. Able to give informed consent 3. Meets criteria for implant of Sapien Aortic Valve 4. Availability of transtemporal windows Exclusion Criteria: 1. Pregnancy 2. Having a metallic foreign body in orbit 3. Previous aneurysm surgery 4. Unable or unwilling to give informed consent and follow up with study activities |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann ARbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Emboli | Measured through transcranial doppler | During the procedure | No |
Secondary | stroke | The primary neurological outcome will be defined by the change in the NIH stroke scale from the pre-procedure examination. We will display this outcome visually using spaghetti plots labeled with emboli count for each patient. Using the method of mixed models with an empirical small-sample correction, a longitudinal model adjusted for follow-up time will be used to compare this outcome at each post-procedural assessment to emboli count. While tracked, we don't anticipate any strokes within this first set of 8 pilot patients. | pre-op, prior to discharge but within 10 days of the procedure, & 3 months post-discharge | No |
Secondary | Lesions on brain imaging | The primary neurobehavioral outcome will be defined at each post-procedural visit by a 20% or greater decline on at least 20% of neurobehavioral tests relative to pre-procedural levels. A similar longitudinal model to that used for NIH stroke score will be used to generate odds ratios for the effect of emboli count on post-procedural neurobehavioral deficit. Secondary outcomes, including the change over time in the mini mental status examination (MMSE) and Montreal Cognitive Assessment (MoCA), will be assessed as continuous outcomes in longitudinal models predicted by emboli count as well as visually in plot form. | pre-op, prior to discharge but within 10 days of the procedure, & 3 months post-discharge | No |
Secondary | Neurobehavioral | The primary neurobehavioral outcome will be defined at each post-procedural visit by a 20% or greater decline on at least 20% of neurobehavioral tests relative to pre-procedural levels. A similar longitudinal model to that used for NIH stroke score will be used to generate odds ratios for the effect of emboli count on post-procedural neurobehavioral deficit. Secondary outcomes, including the change over time in the mini mental status examination (MMSE) and Montreal Cognitive Assessment (MoCA), will be assessed as continuous outcomes in longitudinal models predicted by emboli count as well as visually in plot form. | pre-op, prior to discharge but within 10 days of the procedure, & 3 months post-discharge | No |
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