NCT04029233

The PROOF Trial - Prospective, Open-label, Multicenter, Non-randomized Investigation on Percutaneous Patent Foramen Ovale (PFO) Closure Using the Occlutech PFO Occluder to Prevent Recurrence of Stroke in Patients With Cryptogenic Stroke and High Risk PFO

Prospective, Open-label, Multicenter, Non-randomized Investigation on Percutaneous Patent Foramen Ovale (PFO) Closure Using the Occlutech PFO Occluder to Prevent Recurrence of Stroke in Patients With Cryptogenic Stroke and High Risk PFO

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 582 (actual)
• Sponsor: Occlutech International AB · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism.

Detailed description

This study aims to investigate stroke recurrence rates after interventional PFO closure with an Occlutech PFO Occluder in patients who have experienced at least one ischemic cryptogenic stroke attributed to patent foramen ovale (PFO) who have high risk PFO, i.e. large PFO (≥2 mm), or PFO of any size and atrial septal aneurysm (ASA).

Conditions

• Stroke
• PFO - Patent Foramen Ovale

Interventions

Type	Name	Description
DEVICE	Occlutech PFO Occluder	The Occlutech PFO Occluder is a medical device for transcatheter closure of PFO.

Timeline

• Start date: 2019-10-03
• Primary completion: 2024-04-16
• Completion: 2024-04-16
• First posted: 2019-07-23
• Last updated: 2024-09-19

Locations

17 sites across 4 countries: Canada, France, Germany, Italy