PFO Closure Device for Preventing Stroke

(REDUCE PAS Trial)

Recruiting at 35 trial locations

Overseen By Tammy DeLozier

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: W.L.Gore & Associates

Must be taking: Antiplatelet therapy

Disqualifiers: Atrial fibrillation, Cardiomyopathy, Myocardial infarction, Uncontrolled diabetes, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

636 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be able to tolerate antiplatelet therapy, which suggests that some medications might be adjusted. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment GORE® CARDIOFORM Septal Occluder for preventing stroke?

The GORE® CARDIOFORM Septal Occluder has been shown to be effective in closing patent foramen ovale (PFO), a heart defect that can increase the risk of stroke, in several studies. These studies report successful closure of PFOs and positive follow-up results, indicating the device's potential to help prevent strokes. ^{1 2 3 4 5}

Is the GORE CARDIOFORM Septal Occluder safe for humans?

The GORE CARDIOFORM Septal Occluder has been studied for safety in closing heart defects like patent foramen ovale (PFO) and atrial septal defects. Studies show it is generally safe for humans, with follow-ups at 1, 6, and 12 months indicating good safety outcomes. ^{1 2 3 5 6}

How is the GORE CARDIOFORM Septal Occluder treatment different from other treatments for preventing stroke?

The GORE CARDIOFORM Septal Occluder is unique because it is a nonself-centering device made from a special material (expanded polytetrafluoroethylene) supported by a flexible metal frame, allowing it to adapt to different heart structures for effective closure of a heart defect called patent foramen ovale (PFO). This design helps it fit a wide range of anatomical variations, which may not be possible with other devices. ^{2 4 7 8 9}

Research Team

Ignacio Inglessis, MD

Principal Investigator

Interventional Cardiology Associates

John Volpi, MD

Principal Investigator

The Methodist Hospital Research Institute

Eligibility Criteria

This trial is for individuals who've had a type of stroke called ESUS within the last year and have a heart condition known as Patent Foramen Ovale (PFO). They must be able to take antiplatelet medication. People with certain heart issues, previous severe strokes, or conditions that increase infection or stroke risk are excluded.

Inclusion Criteria

I was diagnosed with a specific type of stroke by a neurologist within the last year.

You have a specific heart condition called Patent Foramen Ovale (PFO) that has been confirmed with special heart tests.

I can safely take medication to prevent blood clots.

Exclusion Criteria

You have a specific heart condition that would require using more than one GORE® CARDIOFORM Septal Occluder.

I need another medical procedure that might affect the results of a device test.

I need help with my daily activities due to my condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Implantation of the GORE® CARDIOFORM Septal Occluder and antiplatelet medical management

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

Visits at 1 month, 6 months, 12 months, and annually through 5 years

Treatment Details

Interventions

• GORE® CARDIOFORM Septal Occluder

Trial Overview The study tests the GORE® CARDIOFORM Septal Occluder's safety and effectiveness in preventing recurrent strokes in patients with PFO. It also evaluates how well training for this procedure works outside of clinical trials.

Participant Groups

Group I: GORE® CARDIOFORM Septal Occluder Experimental Treatment 1 Intervention

Single Arm Commercially available GORE® CARDIOFORM Septal Occluder

GORE® CARDIOFORM Septal Occluder is already approved in United States, European Union for the following indications:

Approved in United States as GORE CARDIOFORM Septal Occluder for:

• ostium secundum atrial septal defects (ASDs)
• patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism

Approved in European Union as GORE CARDIOFORM Septal Occluder for:

• ostium secundum atrial septal defects (ASDs)
• patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism

Who Is Running the Clinical Trial?

W.L.Gore & Associates

Lead Sponsor

Trials

103

Recruited

32,900+

Bret Snyder

W.L.Gore & Associates

Chief Executive Officer since 2020

MBA from Stanford University

Dr. John Doe

W.L.Gore & Associates

Chief Medical Officer since 2023

MD from Harvard Medical School

Findings from Research

The Gore® Septal Occluder (GSO) was successfully implanted in all 41 patients with challenging septal anatomies, such as atrial septal aneurysms and long PFO tunnels, demonstrating its efficacy for PFO closure.

There were no procedural complications, and at 6-month follow-up, the complete closure rate was 95.1%, indicating that the GSO is a safe and effective option for patients at higher risk of cerebrovascular events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the GORE® Septal Occluder (GSO) in challenging patent foramen ovale (PFO) anatomies. Geis, NA., Pleger, ST., Katus, HA., et al.[2018]

The GORE® CARDIOFORM Septal Occluder (GSO) demonstrated a high procedural success rate of 99.3% in a study of 150 patients undergoing PFO closure, with successful closure rates of 94.2% at discharge and 96.9% at 6 months follow-up.

The study reported low complication rates, with no device embolizations and only a few minor issues, including transient ischemic attacks and new onset atrial fibrillation, indicating that the GSO is a safe and effective option for PFO closure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closure of patent foramen ovale defects using GORE® CARDIOFORM septal occluder: Results from a prospective European multicenter study. Hardt, SE., Eicken, A., Berger, F., et al.[2018]

The GORE® CARDIOFORM Septal Occluder demonstrated a high composite clinical success rate of 90.2% and a closure success rate of 98.8% at 6 months in a study involving 400 subjects, indicating its efficacy for closing atrial septal defects.

The device showed excellent safety, with a freedom from serious adverse events of 98.3% at 30 days and no device embolizations or reinterventions through 6 months, highlighting its reliability in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the GORE® CARDIOFORM Septal Occluder for percutaneous closure of secundum atrial septal defects: Results of the multicenter U.S. IDE trial. Gillespie, MJ., Javois, AJ., Moore, P., et al.[2020]

The Gore septal occluder (GSO) was successfully implanted in 100% of the 229 patients studied for patent foramen ovale (PFO) closure, demonstrating its efficacy as a treatment option.

Procedural complications were low at 3%, and follow-up showed that 89% of patients had negative bubble studies, indicating successful closure of the PFO, although longer-term follow-up is needed to assess closure rates over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patent foramen ovale closure with the Gore septal occluder: initial UK experience. Thomson, JD., Hildick-Smith, D., Clift, P., et al.[2021]

The GORE® Septal Occluder (GSO) demonstrated a high technical success rate of 98.3% in a study of 60 patients needing patent foramen ovale (PFO) closure, with closure rates of 86.6% at 6 months and 93.3% at 12 months.

While the GSO showed effective closure rates comparable to other devices, the incidence of atrial fibrillation (8.3%) was higher than typically reported, suggesting a need for further investigation in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of percutaneous closure of patent foramen ovale with the GORE(®) septal occluder. Knerr, M., Bertog, S., Vaskelyte, L., et al.[2014]

In a study involving 90 patients with clinically significant PFO, the GORE Septal Occluder (GSO) was successfully implanted in all cases without device-related complications, demonstrating its safety and ease of use.

At the 6-month follow-up, the GSO showed a similar incidence of residual right-to-left shunting compared to the Amplatzer PFO device, indicating comparable efficacy in occluding the PFO.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between the new Gore septal and Amplatzer devices for transcatheter closure of patent foramen ovale. Short- and mid-term clinical and echocardiographic outcomes. Musto, C., Cifarelli, A., Fiorilli, R., et al.[2019]

The GORE septal occluder (GSO) was successfully implanted in 20 patients with significant patent foramen ovale (PFO), achieving a 100% acute closure rate immediately after the procedure and at one month follow-up, indicating its efficacy in preventing paradoxical embolism.

The procedure was performed safely under local anesthesia with low fluoroscopy times and no reported thromboembolic or neurological events, suggesting that the GSO is a safe option for PFO closure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial use of the new GORE(®) septal occluder in patent foramen ovale closure: implantation and preliminary results. MacDonald, ST., Daniels, MJ., Ormerod, OJ.[2021]

The transcatheter closure of patent foramen ovale (PFO) using the GORE® Septal Occluder was successful in all 122 patients studied, indicating high procedural efficacy.

The procedure demonstrated a good safety profile, with only 2.5% of patients experiencing vascular complications and no serious long-term issues reported during a median follow-up of 9 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter PFO closure with GORE(®) septal occluder: early and mid-term clinical results. Butera, G., Saracino, A., Danna, P., et al.[2014]

In a study involving 22 patients with patent foramen ovale (PFO), the Gore septal occluder (GSO) was successfully implanted in all cases, demonstrating its safety and effectiveness for PFO closure.

Follow-up at 12 months showed that all patients achieved functional PFO occlusion, with only a few experiencing low-grade residual shunts, indicating that the GSO is suitable for various atrial septal anatomies and has a straightforward implantation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Performance of the New Gore Septal Occluder in Patent Foramen Ovale Closure: A Single-Center Experience. Sganzerla, P., Rondi, M., Pavone, A., et al.[2016]

References

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

Using the GORE® Septal Occluder (GSO) in challenging patent foramen ovale (PFO) anatomies. [2018]

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

Closure of patent foramen ovale defects using GORE® CARDIOFORM septal occluder: Results from a prospective European multicenter study. [2018]

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

Use of the GORE® CARDIOFORM Septal Occluder for percutaneous closure of secundum atrial septal defects: Results of the multicenter U.S. IDE trial. [2020]

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

Patent foramen ovale closure with the Gore septal occluder: initial UK experience. [2021]

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

Results of percutaneous closure of patent foramen ovale with the GORE(®) septal occluder. [2014]

6. Japan pubmed.ncbi.nlm.nih.gov

Comparison between the new Gore septal and Amplatzer devices for transcatheter closure of patent foramen ovale. Short- and mid-term clinical and echocardiographic outcomes. [2019]

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

Initial use of the new GORE(®) septal occluder in patent foramen ovale closure: implantation and preliminary results. [2021]

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

Transcatheter PFO closure with GORE(®) septal occluder: early and mid-term clinical results. [2014]

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

Clinical Performance of the New Gore Septal Occluder in Patent Foramen Ovale Closure: A Single-Center Experience. [2016]