| |
Baseline
|
Hospitalization
|
6 months
|
1 year
|
2 years
|
3 years
|
4 years
|
5 years
|
|---|
|
History
|
x
| |
x
|
x
|
x
|
x
|
x
|
x
|
|
Listing of antithrombotic medications
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Laboratory survey
|
x
| | | | | | | |
|
12 lead ECG
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Holter ECG
|
x
| | | | | | | |
|
TEE*
|
x
|
X (TTE or TEE)
|
x
| | | | |
(x)
|
|
CT/MR or angiography of region of interest (brain or periphery)
|
x
| | | | | | | |
|
Carotid Doppler
|
x
| | | | | | | |
|
Employment status
|
x
| |
x
|
x
|
x
|
x
|
x
|
x
|
|
Quality of life
|
x
| |
x
|
x
|
x
|
x
|
x
|
x
|
|
Stroke outcome classification (NIH SS, Barthel index, Modified Rankin scale)
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Procedural complications
| |
x
| | | | | | |
|
Primary endpoints
| | |
x
|
x
|
x
|
x
|
x
|
x
|
|
Secondary endpoints
| | |
x
|
x
|
x
|
x
|
x
|
x
|
- *TEE examination after 6 months and possibly yearly thereafter until complete closure of the PFO has been documented. A TEE at 5 years of follow-up or termination of the study is optimal; a TTE is acceptable immediately following device closure.
