Clinical Investigation of the Safety and Effectiveness of the Occlutech Flex II PFO Occluder: Design and Rationale of the Multicenter, Randomized OCCLUFLEX Trial
Bibliographic record
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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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.086 | 0.072 |
| Meta-epidemiology (narrow) | 0.004 | 0.002 |
| Meta-epidemiology (broad) | 0.006 | 0.004 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.002 | 0.004 |
| Scholarly communication | 0.004 | 0.003 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.006 | 0.004 |
| Insufficient payload (model declined to judge) | 0.008 | 0.003 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".