NCT05069558

Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Occlutech International AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to investigate whether percutaneous PFO closure with the Occlutech Flex II PFO Occluder is non-inferior to the AMPLATZER™ PFO Occluder and Gore® Cardioform Septal Occluder in closure of the PFO, prevention of recurrent embolic stroke, and device/procedure related Serious Adverse Events (SAE).

Conditions

• Stroke
• Patent Foramen Ovale
• PFO

Interventions

Type	Name	Description
DEVICE	Investigational PFO Closure Device	Occlutech Flex II PFO Closure Device
DEVICE	Standard of Care PFO Closure Device	Amplatzer PFO Occluder and Gore Cardioform PFO Occluder

Timeline

• Start date: 2022-05-09
• Primary completion: 2025-11-30
• Completion: 2029-11-01
• First posted: 2021-10-06
• Last updated: 2026-03-03

Locations

48 sites across 8 countries: United States, Canada, Denmark, Finland, France, Germany, Netherlands, United Kingdom

Regulatory

• FDA-regulated device study