PFO Closure for Stroke

(STOP Trial)

Overseen By Melanie Cote, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Josep Rodes-Cabau

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Atrial fibrillation, Hypertension, Cancer, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

714 Participants Needed

Trial Summary

What is the purpose of this trial?

Patent foramen ovale PFO closure has been shown to reduce the risk of stroke in patients with recurrent stroke. However, the majority of existing clinical studies in this field excluded patients over the age of 60 years. Data in older patients is limited and since the population ages and stroke remains a major cause of death and morbidity, randomized clinical trials are needed to better assess the benefit of PFO closure in this elderly population. Therefore, this study proposal sought to determine the efficacy of PFO closure for the prevention of recurrent stroke in older patients with PFO and cryptogenic stroke.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you need chronic anticoagulation therapy or have a contraindication for antiplatelet therapy like aspirin or clopidogrel.

What data supports the effectiveness of the treatment for PFO closure in preventing strokes?

Research shows that closing a PFO (a small hole in the heart) is better at preventing strokes than just using medicine alone. This has been proven in several large studies, making PFO closure the preferred choice for preventing strokes in people with this condition. ^{1 2 3 4 5}

Is transcatheter PFO closure generally safe for humans?

Transcatheter PFO closure is generally considered safe, but the safety can depend on the specific device used. It is a routine procedure, though complications can occur during the process. ^{1 6 7 8 9}

How does transcatheter PFO closure differ from other treatments for stroke prevention?

Transcatheter PFO closure is a unique treatment for stroke prevention as it involves a minimally invasive procedure to close a small hole in the heart (patent foramen ovale) that can allow blood clots to pass from one side of the heart to the other, potentially causing a stroke. This approach is different from traditional treatments like long-term use of blood thinners, as it directly addresses the structural heart defect rather than just managing the risk of clot formation. ^{1 4 5 10 11}

Research Team

IUCPQ Rodes-Cabau, MD, PhD

Principal Investigator

Fondation IUCPQ

Eligibility Criteria

This trial is for individuals over 60 years old who have had a cryptogenic stroke, which means the cause of their stroke was unknown, and they also have a patent foramen ovale (PFO), a small opening in the heart. They must show evidence of right-to-left shunt on an echocardiogram.

Inclusion Criteria

I had a stroke with an unknown cause.

I am older than 60 years.

You have a heart condition called a right-to-left shunt, as confirmed by an echocardiogram.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either transcatheter PFO closure with optimal medical treatment or optimal medical treatment alone

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of stroke events and mortality

10 years

Treatment Details

Interventions

• Optimal medical treatment
• Transcatheter PFO closure

Trial Overview The study is testing whether closing the PFO with a special procedure called transcatheter closure can prevent future strokes compared to just receiving optimal medical treatment without closure. The participants will be randomly assigned to one of these two approaches.

Participant Groups

Group I: transcatheter PFO closure + optimal medical treatment Experimental Treatment 2 Interventions

Patients will undergoes transcatheter PFO closure (+ optimal medical treatment). Patients will receive antithrombotic agents (single antiplatelet treatment ), and modifiable vascular risk factors (dyslipidemia, hypertension, diabetes) according to stroke prevention guidelines. The type of antithrombotic therapy will be left to the discretion of the physician responsible for the patient.

Group II: Optimal medical treatment Experimental Treatment 1 Intervention

Patients will receive antithrombotic agents (single antiplatelet treatment ), and modifiable vascular risk factors (dyslipidemia, hypertension, diabetes) according to stroke prevention guidelines. The type of antithrombotic therapy will be left to the discretion of the physician responsible for the patient.

Who Is Running the Clinical Trial?

Josep Rodes-Cabau

Lead Sponsor

Trials

4

Recruited

1,400+

References

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

[Patent foramen ovale - an unsuspected defect in the body]. [2016]

2. England pubmed.ncbi.nlm.nih.gov

A novel system for transcatheter closure of patent foramen ovale: clinical and echocardiographic outcome comparison with other contemporary devices. [2016]

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

Practice advisory: Recurrent stroke with patent foramen ovale (update of practice parameter): Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. [2022]

4. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Residual Right-to-Left-Shunt Following Transcatheter Patent Foramen Ovale Closure: The Role of Antithrombotic Treatment. [2023]

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

Initial experience with a transcatheter septal closure system for secondary stroke prevention in patients with interatrial septal defects. [2012]

6. Australia pubmed.ncbi.nlm.nih.gov

Early experience with a simplified technique for transcatheter closure of the patent foramen ovale. [2012]

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

Propensity-Score Matched Comparison of the Cera PFO Occluder With the Amplatzer PFO Occluder for Percutaneous Closure of Patent Foramen Ovale Without Echocardiographic Guidance. [2019]

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

Comparison of contemporary devices used for transcatheter patent foramen ovale closure. [2014]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Transcatheter Closure of Patent Foramen Ovale: Devices and Technique. [2019]

10. Italy pubmed.ncbi.nlm.nih.gov

Percutaneous transcatheter closure of patent foramen ovale. [2014]

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

Percutaneous transcatheter closure of patent foramen ovale in patients with paradoxical embolism. [2019]