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Table 1 Timetable of prospective investigations during the study.

From: Randomized clinical trial comparing percutaneous closure of patent foramen ovale (PFO) using the Amplatzer PFO Occluder with medical treatment in patients with cryptogenic embolism (PC-Trial): rationale and design

 

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

  1. *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.