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International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry

Study acronym: IMPROVE
StatusActive, Not Recruiting
PhaseNot specified
Started2019-11-13
View on ClinicalTrials.gov ↗
3,268 trials monitored
See 122 trials at risk
Patent foramen ovale (PFO) is a prevalent cause of ischemic stroke and transient ischemic attack (TIA) in young patients. Its role as a cause of cerebrovascular events in the older population is more controversial because of other competing causes are more frequent in the elderly. Recent randomized controlled trials (RCTs) have shown that PFO closure is associated with a 59% relative risk reduction in the risk of recurrent ischemic stroke. As such, the number of PFO closure procedures are expected to increase substantially in the upcoming years. Real world data (RWD) informing on the medical management, the risk of stroke recurrence, incident atrial fibrillation, and other outcomes in stroke patients with PFO, with and without PFO closure, will become crucial for understanding how results from RCTs are translated into clinical practice globally. The IMPROVE (International Multicenter Patent foRamen OVale \& strokE) Registry is an observational, multicenter, international registry of men and women with an ischemic stroke or TIA. The aim is to enroll 8,800 patient-years at ≥50 sites in ≥20 countries. The IMPROVE Registry will provide important information about the management and related outcomes of patients with ischemic stroke or TIA and PFO throughout different regions of the world and across a wide spectrum of healthcare systems.
Trial Details
NCT Number NCT04738071
Lead Sponsor Luciano A. Sposato
Conditions Stroke, Patent Foramen Ovale, Atrial Fibrillation, Atrial Flutter
Enrollment 3,730 participants
Start Date 2019-11-13
Primary Completion 2022-11-13 (estimated)
Study Completion 2026-11-13 (estimated)
Updated on ClinicalTrials.gov 2026-09-18