ArticleJournal of the Society for Cardiovascular Angiography & Interventions2026
Clinical Investigation of the Safety and Effectiveness of the Occlutech Flex II PFO Occluder: Design and Rationale of the Multicenter, Randomized OCCLUFLEX Trial.
Article in Journal of the Society for Cardiovascular Angiography & Interventions, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05069558 (Prospective Randomized Multi-center Controlled Clinical Investigation Comparing Patent Foramen Ovale), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prospective Randomized Multi-center Controlled Clinical Investigation Comparing Patent Foramen Ovale (PFO) Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion
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3 authors.
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Abstract
Background: The Prospective Randomized Multi-center Controlled Clinical Investigation Comparing Patent Foramen Ovale (PFO) Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion (OCCLUFLEX) trial (NCT05069558) is designed to evaluate whether percutaneous PFO closure with the Occlutech Flex II PFO Occluder is noninferior to closure with the AMPLATZER Talisman PFO Occluder and Gore CARDIOFORM Septal Occluder. Methods: Enrollment will include 450 subjects across 48 centers in the United States, Canada, and Europe. Enrolled subjects will be older than 18 years of age with no upper age limit, have a cryptogenic stroke likely attributable to paradoxical embolism, as determined by a neurologist and cardiologist following evaluation to exclude other causes of ischemic stroke, and with an echocardiographically confirmed PFO. Eligible subjects will be randomized 1:1 to receive a Occlutech Flex II PFO Occluder or standard of care PFO occluder (either the AMPLATZER or Gore device). Randomization should occur within 5 working days before the procedure. Subjects will be followed with scheduled assessments conducted at discharge, 1 month, 6 months, and 12 months postprocedure and annually to 5 years, transitioning into a postapproval study, contingent upon premarket approval. The primary end point is effective PFO closure at 12 months by echocardiographic bubble study, the secondary end point is nonfatal recurrent stroke through 12 months, and the safety end point is all device- and procedure-related serious adverse events within 12 months including postprocedural atrial fibrillation. Conclusions: OCCLUFLEX is the first multicenter randomized trial directly comparing PFO closure devices. This trial will offer valuable evidence for physicians, including procedural characteristics, device success, postimplant atrial fibrillation rates, and outcomes in patients aged >60 years.
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