Table 3.

Ongoing studies on older (≥60 years) patients with PFO-related cerebrovascular events

Study name	Study locations	Study type	Estimated enrollment	Age-related considerations	Design model	Study population or groups	Primary outcome	Estimated completion date
CLOSE-2 [64]	31 Centers in France	Clinical trial	792	Patients aged 60 to 80 years	Randomized	- PFO closure plus antiplatelet therapy vs. antiplatelet therapy alone	Time to recurrent stroke (ischemic or hemorrhagic fatal or non-fatal)	June 1, 2030
						- Oral anticoagulation vs. antiplatelet therapy
COACH ESUS [65]	Multicentric, Korea	Observational	1,200	60 years and older	Case-control	- PFO closure plus standard antiplatelet treatment vs. standard antiplatelet only	Ischemic stroke recurrence	May 31, 2027
DefenseElderly [66]	Multicentric, Korea	Observational	300	60 years and older	Cohort	- ESUS and PFO that is likely to have causative role (high-risk anatomical feature)	Paroxysmal AF episodes >30 seconds detected with intermittent recordings or ≥2 minutes during ICM within 6 months	October 2, 2024
						- ESUS without PFO, or with non-high risk PFO
International PFO Consortium [67]	19 Centers, international	Observational	1,500	18 years and older	Cohort	- PFO closure vs. antithrombotic therapy alone	Proportion of patients free of any stroke (including fatal stroke) or TIA	December 2021
							*Etiological role of PFO for stroke/TIA in patients aged >55 years

PFO, patent foramen ovale; ESUS, embolic stroke of undetermined source; AF, atrial fibrillation; ICM, insertable cardiac monitoring.

^*Listed as one of the main study objectives; CLOSE-2, PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years; COACH ESUS, Prospective Registry of Elderly ESUS With PFO; DefenseElderly, Evaluation of Prevalence and Clinical Impact of Atrial Fibrillation in Elderly Patients With Cryptogenic Stroke and High-Risk Patent Foramen Ovale.