cerebrovascular incident stroke TIA
Conditions
Interventions
The EM-blocker* shall be activated at different times during the operation.
These moments are mostly at times the aorta is manipulated, like during
cannulation and decannulation, the insertion of th
Sponsors
Neurosonix Ltd
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 65
Exclusion criteria
Exclusion criteria: Off-pump surgery Temporal window not detected for transcranial doppler measurements Re-do procedure Emergency operation required Has a life threatening debilitating disease other than cardiac Stroke history (pre-excisting TIA and/or CVA) Patients with renal failure requiring dialysis The patient has been treated with an investigational drug or device within 30 days prior to surgery and/or will be treated peri- or post-operatively
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy endpoint: the amount of embolic signals, registered with the TCD. Primary safety endpoint: absence of device-related serious complications. | — |
Countries
Netherlands
Outcome results
None listed