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

NCT01927601 | Withdrawn

• 2 other identifiers: HUM00068534Neuro-TAVR
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Severe Symptomatic Aortic Stenosis

Keywords

TAVR; aortic disease

Outcome Measures

Primary Outcomes (1)

• Emboli

  Measured through transcranial doppler

  During the procedure

Secondary Outcomes (3)

• stroke

  pre-op, prior to discharge but within 10 days of the procedure, & 3 months post-discharge

• Lesions on brain imaging

  pre-op, prior to discharge but within 10 days of the procedure, & 3 months post-discharge

• Neurobehavioral

  pre-op, prior to discharge but within 10 days of the procedure, & 3 months post-discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients eligible for TAVR

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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Aortic Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 16, 2013
• First Posted: August 22, 2013
• Study Start: August 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: February 1, 2017
• Last Updated: October 26, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)