PFO Closure Devices for Stroke Prevention

(OCCLUFLEX Trial)

Recruiting in Palo Alto (17 mi)

+55 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Occlutech International AB

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

Research Team

David Thaler, MD, PhD, FAHA

Principal Investigator

Tufts Medical Center and Tufts University School of Medicine

Steven Yakubov, MD, FACC, MSCAI

Principal Investigator

OhioHealth Heart & Vascular

Eligibility Criteria

This trial is for adults aged 18 and over who've had a stroke of unknown cause (cryptogenic) linked to a heart condition called Patent Foramen Ovale (PFO). Participants must be able to stop anticoagulation meds, have a life expectancy over 2 years, and not have other conditions causing strokes or serious heart issues.

Inclusion Criteria

I have a hole in my heart and had a stroke with an unknown cause.

You have a condition called a patent foramen ovale (PFO) that allows bubbles to pass from the right side of the heart to the left side.

I had a stroke, but doctors don't know why.

Exclusion Criteria

I am at least 18 years old but not older than 50.

I have a severe heart valve problem.

You have growths or artificial valves in your heart.

Treatment Details

Interventions

• Investigational PFO Closure Device (PFO Occluder)
• Standard of Care PFO Closure Device (PFO Occluder)

Trial Overview The study compares the Occlutech Flex II PFO Occluder with standard devices like the AMPLATZER™ PFO Occluder in preventing strokes by closing the PFO. It looks at how well they work and their safety by tracking Serious Adverse Events related to them.

Participant Groups

Group I: Investigational PFO Closure Device Experimental Treatment 1 Intervention

PFO closure with the study Occlutech Flex II PFO device.

Group II: Standard of Care PFO Closure Device Active Control 1 Intervention

PFO closure with either of the standard of care PFO occlusion devices; Amplatzer PFO Occluder or the Gore Cardioform PFO Occluder.

Who Is Running the Clinical Trial?

Occlutech International AB

Lead Sponsor

Trials

16

Recruited

4,100+