Trials / Completed
CompletedNCT02073864
A Study to Evaluate the Neuro-embolic Consequences of TAVR
Neurological Complications of Contemporary Unprotected TAVR (Yale Neuro TAVR)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 46 (actual)
- Sponsor
- Keystone Heart · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, multi-center study to evaluate the neuro-embolic consequences of Transcatheter Aortic Valve Replacement (TAVR)
Detailed description
Prospective, multi-center study enrolling a minimum of 20 up to a maximum of 80 patients at up to six investigational sites in the United States and European Union. Patients meeting eligibility criteria for TAVR will be enrolled to undergo diffusion-weighted MRI brain imaging pre-procedure (optional) and post-procedure and neuropsychological testing pre- and post-procedure, and at 30 days of follow-up.
Conditions
Timeline
- Start date
- 2013-11-01
- Primary completion
- 2015-06-01
- Completion
- 2015-08-01
- First posted
- 2014-02-27
- Last updated
- 2015-08-27
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02073864. Inclusion in this directory is not an endorsement.