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

Table 1 Timetable of prospective investigations during the study.

	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.