AMPLATZER PFO Occluder for Patent Foramen Ovale

(PFO PAS Trial)

Recruiting at 91 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

1214 Participants Needed

Trial Summary

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 data supports the effectiveness of the AMPLATZER PFO Occluder treatment for Patent Foramen Ovale?

Research shows that the AMPLATZER PFO Occluder is effective in closing a patent foramen ovale (a small hole in the heart) and helps prevent stroke recurrence in patients who have had strokes due to paradoxical embolism (a type of blood clot). Studies have demonstrated successful outcomes without severe complications in many patients. ^{1 2 3 4 5}

Is the AMPLATZER PFO Occluder generally safe for humans?

The AMPLATZER PFO Occluder has been used in many patients without severe complications, but there have been reports of issues like new-onset atrial fibrillation (irregular heartbeat), residual shunt (incomplete closure), and other device-related problems. Long-term follow-up is recommended to monitor for complications that may appear years after the device is placed. ^{1 3 4 6 7}

How is the AMPLATZER PFO Occluder treatment different from other treatments for patent foramen ovale?

The AMPLATZER PFO Occluder is unique because it is a device specifically designed for percutaneous (through the skin) closure of a patent foramen ovale (a hole in the heart), which helps prevent stroke recurrence by stopping blood clots from passing through the hole. Unlike medication, this treatment involves a minimally invasive procedure to physically close the opening in the heart. ^{1 2 4 5 8}

What is the purpose of this trial?

The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZER™ PFO Occluder in the post Approval Setting.

Research Team

Barathi Sethuraman, PhD

Principal Investigator

Abbott

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

References

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

Comparison of the short-term efficacy of different Amplatzer models and similar occluders in the treatment of patent foramen ovale. [2023]

2. Mexico pubmed.ncbi.nlm.nih.gov

[Percutaneous closure of patent foramen ovale with amplatzer device. Report of two cases]. [2007]

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

Is routine ultrasound guidance really necessary for closure of patent foramen ovale using the Amplatzer PFO occluder? [2016]

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

Cardiac perforation following transcatheter PFO closure. [2016]

5. France pubmed.ncbi.nlm.nih.gov

A propensity score-matched comparison between Cardia and Amplatzer PFO closure devices - insights from the SOLUTION registry (Swiss percutaneOus patent foramen ovale cLosUre in recurrent clinical events prevenTION). [2015]

6. England pubmed.ncbi.nlm.nih.gov

Percutaneous closure of patent foramen ovale: impact of device design on safety and efficacy. [2019]

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

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

8. England pubmed.ncbi.nlm.nih.gov

Application of Transesophageal Echocardiography in Amplatzer Atrial Septal Defect Occluder for Percutaneous Closure of Large Patent Foramen Ovale. [2022]