AMPLATZER PFO Occluder for Patent Foramen Ovale

(PFO PAS Trial)

Not currently recruiting at 105 trial locations

Overseen By Maren Wagner

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Medical Devices

Must not be taking: Antiplatelets

Disqualifiers: Atherosclerosis, Intracardiac thrombus, Pregnancy, Organ failure, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of the AMPLATZER™ PFO Occluder, a device designed to close a small hole in the heart known as a Patent Foramen Ovale (PFO). It aims to assist individuals who have suffered a stroke due to this heart condition. The trial targets those who have experienced an ischemic stroke (a type of stroke caused by a blockage) within the last year and a half and have a PFO. Participants should not have other heart issues, such as blocked arteries or recent heart attacks. As an unphased trial, this study allows participants to contribute to important research that could enhance stroke prevention for others with similar heart conditions.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, you must be able to take antiplatelet therapy to participate.

What prior data suggests that the AMPLATZER™ PFO Occluder is safe?

Research shows that the AMPLATZER™ PFO Occluder is designed to close a small opening in the heart called a patent foramen ovale (PFO). Studies confirm that the FDA has approved this device for this purpose, indicating it has been tested for safety and effectiveness.

Most patients tolerate the device well. Serious side effects are rare, but as with any medical procedure, some risks exist. These might include minor discomfort at the placement site. However, the benefits often outweigh the risks, particularly in reducing the chance of another stroke.

For those considering joining a trial with this device, existing data provides reassurance about its safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The AMPLATZER™ PFO Occluder is unique because it offers a mechanical solution to close a patent foramen ovale (PFO), a small hole in the heart that can lead to strokes. Unlike medication, which primarily manages symptoms or prevents blood clots, this device aims to address the root cause by physically sealing the PFO. Researchers are excited because it provides a minimally invasive alternative to open-heart surgery, potentially reducing recovery time and improving outcomes for patients at risk of recurrent strokes.

What evidence suggests that the AMPLATZER™ PFO Occluder is effective for Patent Foramen Ovale?

Studies have shown that the AMPLATZER™ PFO Occluder, which participants in this trial will receive, effectively lowers the risk of another stroke in people with a patent foramen ovale (PFO). Research indicates a 1.5% chance of another stroke within nine years after using this device. The device is placed and functions correctly in nearly all cases, with a success rate of 99.1%. It has also proven more effective than medication alone in preventing further strokes. To prevent one stroke over five years, 27 people need treatment with this device, highlighting its significant benefit. ^{2 3 6 7 8}

Who Is on the Research Team?

Barathi Sethuraman, PhD

Principal Investigator

Abbott

Are You a Good Fit for This Trial?

This trial is for people aged 18-60 who've had a stroke linked to a heart defect called PFO within the last 547 days. They must be able to take antiplatelet therapy and commit to follow-up visits. It's not for those with uncontrolled high blood pressure, certain heart conditions, severe infections, recent serious heart events, or other identified causes of stroke.

Inclusion Criteria

I have had a stroke caused by a heart condition within the last 18 months.

Exclusion Criteria

I have not had a heart attack or unstable chest pain in the last 6 months.

My heart has a weakened or bulging area.

I have severe narrowing or leaking of my aortic valve.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects are implanted with the AMPLATZER™ PFO Occluder

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

1 month, 6 months, 12 months, and annually thereafter

What Are the Treatments Tested in This Trial?

Interventions

• AMPLATZER™ PFO Occluder

Trial Overview The study tests the safety and effectiveness of the AMPLATZER™ PFO Occluder device in patients after it has been approved. This device is designed to close the PFO and potentially reduce the risk of future strokes.

How Is the Trial Designed?

Group I: Device Experimental Treatment 1 Intervention

Subjects implanted with the AMPLATZER™ PFO Occluder.

Who Is Running the Clinical Trial?

Abbott Medical Devices

Lead Sponsor

Trials

659

Recruited

420,000+

Founded

1888

Headquarters

Abbott Park, Illinois, USA

Known For

Medical Devices Innovation

Top Products

FreeStyle Libre, MitraClip, XIENCE Stents, TECNIS IOLs

Dr. Etahn Korngold

Abbott Medical Devices

Chief Medical Officer

Medical training at Harvard Medical School and Massachusetts General Hospital

Robert B. Ford

Abbott Medical Devices

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36165815/

Real world long-term outcomes among adults undergoing ... We observed excellent safety and effectiveness outcomes for PFO closure conducted with Amplatzer PFO Occluder, similar to randomized controlled trials.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167527322013833

Real world long-term outcomes among adults undergoing ... In this study, the risk of recurrent stroke at 9 years follow-up post PFO closure with Amplatzer PFO Occluder was 1.5%.

3. cardiovascular.abbott cardiovascular.abbott/us/en/hcp/products/structural-heart/structural-interventions/amplatzer-talisman.html

Amplatzer Talisman PFO Occluder | PFO Closure Device The AMPLATZER™ PFO Occluder is indicated for percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke ...

4. crf.org crf.org/crf/contact-us/64-tct-2016/press-release/1855-long-term-study-results-show-that-pfo-closure-is-more-effective-than-medical-management-in-preventing-recurrent-stroke

Long-Term Study Results Show That PFO Closure is More ... Technical success (delivery and release of the device) of the PFO closure was 99.1% and procedural success (implantation without in-hospital ...

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf12/p120021b.pdf

FDA - Summary of Safety and Effectiveness Data (SSED) The number needed to treat with the AMPLATZER PFO Occluder to prevent one recurrent stroke at 5 years was 27 in the initial data lock analysis ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf12/P120021c.pdf

PFO Occluder The AMPLATZER™ PFO Occluder is indicated for percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8980243/

Amplatzer Patent Foramen Ovale Occluder Device-Related ... The Amplatzer PFO occluder device has a significantly lower recurrent stroke risk on the sensitivity analysis of three trials that used the ...

8. structuralheart.abbott structuralheart.abbott/patients/treatment/hole-in-heart-pfo-closure

Patent Foramen Ovale Treatment | PFO Closure The Amplatzer Talisman PFO Occluder should not be implanted in patients who: Have a tumor or blood clots at the implantation site of the device or in the ...