The optimal management of patent foramen ovale (PFO) in the setting of cryptogenic stroke is unclear. Prior to the publication of RESPECT, it was unclear whether closure of a PFO was efficacious for secondary stroke prevention after a cryptogenic stroke. A randomized trial using the STARFlex septal closure system (CLOSURE I) did not show superiority over medical therapy alone; however, observational studies had shown newer closure devices to have improved safety features.

To evaluate whether closure of a PFO reduces recurrent ischemic stroke when compared to medical therapy.

Prospective, multicenter, randomized, open-label trial performed at 69 sites in the United States and Canada between 2003 and 2011.