NCT04738071

International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 3,730 (actual)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Stroke
• Patent Foramen Ovale
• Atrial Fibrillation
• Atrial Flutter

Interventions

Type	Name	Description
DEVICE	PFO closure	PFO closure after stroke or transient ischemic attack

Timeline

• Start date: 2019-11-13
• Primary completion: 2022-11-13
• Completion: 2025-11-13
• First posted: 2021-02-04
• Last updated: 2024-03-13

Locations

1 site across 1 country: Canada