PFO Closure Devices for Stroke Prevention

(OCCLUFLEX Trial)

Recruiting at 55 trial locations

Overseen By Ken Lock

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Occlutech International AB

Must not be taking: Aspirin, Clopidogrel

Disqualifiers: Atrial fibrillation, Hypertension, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

450 Participants Needed

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).

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are contraindicated for aspirin or clopidogrel, you cannot participate in the trial.

What data supports the effectiveness of the PFO Closure Devices for Stroke Prevention treatment?

Research shows that closing a patent foramen ovale (PFO), a small hole in the heart, can reduce the risk of having another stroke in certain patients. Studies found that using devices like the Amplatzer PFO occluder can lower the chance of a repeat stroke, especially in people with specific heart conditions, although there is a small risk of complications. ^{1 2 3 4 5}

What safety data exists for PFO closure devices?

PFO closure devices have been linked to several adverse events, including new-onset atrial fibrillation (irregular heartbeat), residual shunt (incomplete closure), device-related blood clots, bleeding, deep vein thrombosis (blood clots in deep veins), pulmonary embolism (blood clots in the lungs), and erosion of the heart wall. Long-term follow-up is recommended as some complications may appear years after the device is placed. ^{6 7 8 9 10}

How does the PFO closure treatment for stroke prevention differ from other treatments?

The PFO closure treatment is unique because it involves a procedure to close a small hole in the heart (patent foramen ovale) that can lead to strokes, rather than relying on medication. This approach has been shown to be more effective than medical therapy for preventing recurrent strokes in patients with PFO. ^{1 3 11 12 13}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo percutaneous PFO closure with either the Occlutech Flex II PFO Occluder or standard of care devices

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and prevention of recurrent embolic stroke after PFO closure

6 months

Multiple visits (in-person)

Treatment Details

Interventions

• Investigational PFO Closure Device
• Standard of Care PFO Closure Device

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+

Findings from Research

In a study involving 267 patients across 23 centers, the Premere™ PFO closure device demonstrated effective closure of patent foramen ovale (PFO), with 71% of patients showing no residual shunt after implantation.

The study reported no occurrences of stroke or transient ischemic attack (TIA) during an average follow-up of 11 months, indicating a strong safety profile for the device in patients with a history of stroke or TIA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PFO closuRE and CryptogenIc StrokE (PRECISE) registry: a multi-center, international registry. Wöhrle, J., Bertrand, B., Søndergaard, L., et al.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

[Patent foramen ovale - an unsuspected defect in the body]. [2016]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Patent foramen ovale closure to prevent secondary neurologic events. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Post-Market Clinical Follow-Up With the Patent Foramen Ovale Closure Device IrisFIT (Lifetech) in Patients With Stroke, Transient Ischemic Attack, or Other Thromboembolic Events. [2021]

4. Italy pubmed.ncbi.nlm.nih.gov

Patent foramen ovale closure. Pro and cons. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Embolic stroke of undetermined source and patent foramen ovale closure: Practice insights from meta-analysis? [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Comparison of contemporary devices used for transcatheter patent foramen ovale closure. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

Amplatzer Patent Foramen Ovale Occluder Device-Related Complications. [2022]

8. France pubmed.ncbi.nlm.nih.gov

Occlusion of PFO with a dedicated adjustable device: influence on one year outcome. [2010]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Occlutech percutaneous patent foramen ovale closure: Safety and efficacy registry (OPPOSE). [2022]

10. Brazil pubmed.ncbi.nlm.nih.gov

Updated Meta-analysis on the Closure of Patent Foramen Ovale in Reduction of Stroke Rates: the DEFENSE-PFO Trial Does not Change the Scenario. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

SCAI expert consensus statement on operator and institutional requirements for PFO closure for secondary prevention of paradoxical embolic stroke: The American Academy of Neurology affirms the value of this statement as an educational tool for neurologists. [2020]

12. Germany pubmed.ncbi.nlm.nih.gov

PFO closuRE and CryptogenIc StrokE (PRECISE) registry: a multi-center, international registry. [2021]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Patent foramen ovale closure: historical perspective. [2005]