Assessment of Neurologic Injury Subsequent to Transcatheter Aortic Valve Replacement: A Feasibility Study

Withdrawn before enrolling

Conditions studied: Severe Symptomatic Aortic Stenosis

In brief

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.

Key facts

Study ID

NCT01927601

Run by

University of Michigan

People needed

0

Starts

2013-08-01

Expected to finish

2017-02-01

Last updated by the study team

2016-10-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults > age 18 years old
• Able to give informed consent
• Meets criteria for implant of Sapien Aortic Valve
• Availability of transtemporal windows

You may not qualify if…

• Pregnancy
• Having a metallic foreign body in orbit
• Previous aneurysm surgery
• Unable or unwilling to give informed consent and follow up with study activities

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.