PFO Closure Device for Preventing Stroke

(REDUCE PAS Trial)

Recruiting at 36 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the GORE® CARDIOFORM Septal Occluder to assess its safety and effectiveness in preventing strokes in individuals with a specific heart condition. This condition, Patent Foramen Ovale (PFO), is a small hole in the heart that can allow blood clots to pass through, potentially causing strokes. The trial seeks participants who have experienced a stroke with no clear cause in the past year and also have PFO. Interested individuals should not have heart rhythm problems like atrial fibrillation or major heart issues such as a past heart attack.

As an unphased trial, this study provides patients the chance to contribute to significant research that could lead to new stroke prevention strategies.

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 prior data suggests that the GORE® CARDIOFORM Septal Occluder is safe for preventing stroke?

Research has shown that the GORE® CARDIOFORM Septal Occluder is safe to use. Studies indicate it carries a low risk of complications for at least five years. Most people do not experience serious side effects with this device. Patients have responded well to the treatment, and it effectively closes the PFO, a small hole in the heart. The device is approved for use, meeting safety standards for its current applications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The GORE® CARDIOFORM Septal Occluder is unique because it offers a minimally invasive approach to closing a patent foramen ovale (PFO), which can help prevent strokes. Unlike traditional treatments that might involve more invasive heart surgery, this device is delivered via a catheter, making the procedure less risky and generally faster to recover from. Researchers are excited about this treatment because it directly targets the PFO with precision, potentially reducing the risk of stroke for patients who have had a prior cryptogenic stroke, without the need for long-term medication management like blood thinners.

What evidence suggests that the GORE® CARDIOFORM Septal Occluder is effective for preventing stroke?

Research has shown that the GORE® CARDIOFORM Septal Occluder reduces the risk of recurrent strokes in some patients. This device closes a small hole in the heart called a patent foramen ovale (PFO), thereby lowering stroke risk. The REDUCE Study found that combining this device with antiplatelet medication is more effective than using the medication alone. Additionally, it offers a cost-effective alternative to other treatments. Overall, the GORE® CARDIOFORM Septal Occluder effectively prevents strokes in individuals with PFO. ^{2 4 6 7 8}

Who Is on the Research Team?

Ignacio Inglessis, MD

Principal Investigator

Interventional Cardiology Associates

John Volpi, MD

Principal Investigator

The Methodist Hospital Research Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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 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]

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]

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 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 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]

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® 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]

Citations

1. goremedical.com goremedical.com/products/cardioform-septal-occluder/clinical-data

GORE ® CARDIOFORM Septal Occluder Clinical Data In carefully selected patients, PFO closure with the GORE® CARDIOFORM Septal Occluder device significantly reduced the risk of recurrent stroke compared to ...

2. goremedical.com goremedical.com/about-us/news/reduce-5-year-study-data-2021-03-11

Gore REDUCE Clinical Study 5-Year Results on PFO ... The REDUCE Study evaluated whether PFO closure with a Gore Device plus antiplatelet therapy reduces the risk of stroke compared to antiplatelet therapy alone.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39365734/

Evaluating cost-effectiveness of PFO management strategies When compared to Medical Therapy Alone, closure with CARDIOFORM was found to be cost-effective, with an incremental cost-effectiveness ratio (ICER) of $36,697 ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29090661/

Patent Foramen Ovale Closure With GORE HELEX or ... The trial should determine whether patent foramen ovale closure with the Gore septal occluders is safe and more effective than medical therapy ...

5. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.030321

Effectiveness of Transcatheter Closure of Patent Foramen ... Transcatheter closure of patent foramen ovale (PFO) has reduced the risk of recurrent stroke in patients with cryptogenic strokes in ...

6. goremedical.com goremedical.com/products/cardioform-septal-occluder

GORE ® CARDIOFORM Septal Occluder 99% effective closure rate across PFO anatomies at 24 months. ... Effective closure defined as freedom from large shunt > 25 bubbles as detected by transthoracic ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03821129

NCT03821129 | GORE® CARDIOFORM Septal Occluder ... This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator ...

8. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.125.015228

Patent Foramen Ovale Closure in Patients With and ... Both the Amplatzer and Gore Cardioform Septal Occluder devices demonstrated comparable safety and efficacy in this population.