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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.