PFO Closure Devices for Stroke Prevention

(OCCLUFLEX Trial)

Not currently recruiting at 58 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores different devices to close a hole in the heart, known as a PFO, which might help prevent recurrent strokes. The researchers compare a new device, the Occlutech Flex II, with two other commonly used devices to determine if the new one is equally effective. Individuals with a PFO and a stroke of unknown cause (cryptogenic stroke) may be suitable candidates, particularly if they have experienced recent unexplained strokes. As an unphased trial, participants can contribute to advancing medical knowledge and potentially benefit from innovative treatment options.

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 prior data suggests that these PFO closure devices are safe for stroke prevention?

Research has shown that patients using the Occlutech Flex II PFO Occluder have a low risk of experiencing problems like transient ischemic attacks (TIAs), or mini-strokes. One study found that only 0.5% of patients had a TIA after receiving the device. Additionally, about 4.7% of patients reported complications shortly after the procedure.

The Amplatzer and Gore Cardioform occluders are standard devices with a strong safety record. These devices are widely accepted for this procedure and are regularly used to prevent strokes by closing a small hole in the heart called a PFO.

Overall, while the Occlutech device is newer, studies suggest it is well-tolerated with a low rate of serious issues. The standard devices have a long history of safe use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the investigational PFO Closure Device because it offers a potentially advanced method for closing a patent foramen ovale (PFO), a small hole in the heart that can lead to strokes. Unlike the standard devices, such as the Amplatzer PFO Occluder and Gore Cardioform PFO Occluder, the new Occlutech Flex II PFO device may provide improved flexibility and adaptability to different heart anatomies. This could result in more effective closures and fewer complications, making it a promising option for stroke prevention.

What evidence suggests that these PFO closure devices are effective for stroke prevention?

Research has shown that the Occlutech Flex II PFO Occluder, which participants in this trial may receive, effectively closes a small hole in the heart called a patent foramen ovale (PFO). One study found that only 0.5% of patients experienced a temporary mini-stroke, known as a transient ischemic attack (TIA), after using the device, indicating its role in preventing stroke-related problems. Long-term data also show very low rates of stroke or TIA recurrence. Another study found that 79.3% of patients achieved successful PFO closure six months after using the device. These findings suggest that the Occlutech device holds promise for preventing repeat strokes. Meanwhile, the trial will also evaluate the effectiveness of standard care PFO closure devices, such as the Amplatzer PFO Occluder or the Gore Cardioform PFO Occluder, in preventing stroke-related issues. ^{1 2 3 6 7}

Who Is on the 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

Are You a Good Fit for This Trial?

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 have a severe heart valve problem.

You have growths or artificial valves in your heart.

I cannot take aspirin or clopidogrel due to health reasons.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1.

jacc.org

jacc.org/doi/10.1016/j.jacc.2023.09.027

TCT-22 Patent Foramen Ovale Closure With the Occlutech ...

Scarce data report the long-term outcomes of patients undergoing PFO closure with the Figulla Flex II device (Occlutech).

2.

occlutech.com

occlutech.com/wp-content/uploads/2024/05/Occlutech-10-Year-Data-A5-ONLINE.pdf

Occlutech 10-year follow up summary and comparator long ...

the Occlutech PFO device show just 2 patients (0.5%) to have suffered recurrent TIA. observed in 4.7% of the patients following index procedure. The majority ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37301447/

Patent foramen ovale closure with the Occlutech Figulla ...

Scarce data report the long-term outcomes of patients undergoing PFO closure with the Figulla Flex II device (Occlutech, Germany).

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0167527323008823

Patent foramen ovale closure with the Occlutech Figulla ...

Patients undergoing PFO Closure with Figulla Flex device had no stroke/TIAs recurrences on a long-term follow-up with very low (2.5%) residual ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28778466/

Occlutech percutaneous patent foramen ovale closure

92 patients underwent six-month BCTTE. The primary endpoint of PFO closure (grade 0 or 1 shunt) at six months was 79.3%. One patient developed ...

6.

clinicaltrial.be

clinicaltrial.be/en/details/174078?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Comparing PFO Outcomes of the Occlutech Flex II ...

The objective of this study is to investigate whether percutaneous PFO closure with the Occlutech Flex II PFO Occluder is non-inferior to ...

7.

occlutech.com

occlutech.com/wp-content/uploads/2021/08/Occlutech_conditional_FDA_approval_PFO_Study-1.pdf

Occlutech granted important conditional FDA approval for ...

The IDE allows Occlutech's PFO Occluder to be used in a clinical study to collect safety and effectiveness data to support a Premarket Approval ...