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Clinical Studies
Articles on PFO closure have been published around the world
PFO closure has been intensively studied in several randomized controlled trials. These trials were designed and conducted to compare PFO closure to medical management to see if there was a greater benefit to patients to have their PFO closed to prevent another stroke.
Read on to learn more.
Amplatzer™ PFO Occluder Post Approval Study (PFO PAS)
Abbott continues to collect clinical data on PFO Closure with the Amplatzer™ PFO Occluder through our Post Approval Study.
In order to continue to evaluate the long-term safety and effectiveness of the FDA-approved Amplatzer™ PFO Occluder, Abbott is partnering with cardiologists and neurologists across the US and Canada to enroll 1,215 patients into a study at up to 100 sites. Adults between the ages of 18 and 60 years who have a patent foramen ovale (PFO) and have had a stroke of unknown cause (i.e., a cryptogenic stroke) in the last 1.5 years may be eligible to participate. Study enrollment is underway, and patients will be followed for five years after they receive the device.
If you would like to learn more about this exciting study and find out if you are eligible to participate, please talk with your doctor. (S)he will help you locate a participating medical facility near you. You can also find additional information about the study below.
The RESPECT trial¹
The RESPECT Trial focused on the long-term outcomes of patent foramen ovale closure as compared to medical therapy after stroke. This trial was conducted in the United States and studied 980 patients who had a recent cryptogenic stroke and were found to have a PFO. The trial compared two groups of patients and followed them for a median of 5.9 years. One group had their PFO closed and took antiplatelet medication; the other group did not have their PFO closed – they only took antithrombotic medication (antiplatelets or anticoagulants). The study results showed that PFO closure was associated with a lower rate of recurrent stroke than medication alone.
REDUCE trial²
The REDUCE Trial focused on patent foramen ovale closure as compared to antiplatelet therapy for cryptogenic stroke. This was a multinational trial and studied patients from Canada, Denmark, Finland, Norway, Sweden, and the United States. 664 patients with a recent cryptogenic stroke and a PFO participated. The trial compared two groups of patients and followed them for a median of 3.2 years. One group of patients had their PFO closed and took antiplatelet medication, while the other group only took antiplatelet medication. The study results showed that PFO closure was associated with a lower rate of recurrent stroke than antiplatelet medication alone.
CLOSE Trial³
The CLOSE Trial studied patent foramen ovale closure and compared it to antiplatelet medication alone and anticoagulation medication alone. This study was conducted in France and Germany and studied 663 recent cryptogenic stroke patients who had a PFO. Patients were split into three groups: PFO closure and antiplatelet medication, antiplatelet medication alone, or anticoagulation medication alone. Patients were followed for a median of 5.3 years. The study results showed that patients who had their PFO closed and took antiplatelet medication had a lower rate of stroke recurrence than patients who only took antiplatelet medication. There were not enough data to draw a conclusion between PFO closure and anticoagulation medication.
- Saver JL, Carroll JD, Thaler DE, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017; 377: 1022-32.
- Søndergaard L, Kasner SE, Rhodes JF, et al. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med. 2017; 377: 1033-42.
- Mas J-L, Derumeaux G, Guillon B, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med. 2017; 377: 1011-21.