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Clinical Studies
PFO closure has been extensively studied
There are several randomized controlled trials studying PFO closure devices, including the RESPECT trial for the Amplatzer PFO Occluder. 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.
The RESPECT trial¹
Device Used: Amplatzer™ PFO Occluder
Number of patients: 980
Timeframe: Median 5.9 years follow-up
Key result: Lower rate of stroke recurrence with the Amplatzer PFO Occluder plus medication* than medication alone.
*Antithrombotic medication (antiplatelets or anticoagulants).
Amplatzer™ PFO Occluder and Amplatzer™ Talisman™ PFO Occluder post approval study (PFO PAS)
Abbott continues to collect data on our PFO closure devices. In fact, enrollment for a large study is currently underway. Talk to your doctor to find out if you are eligible to participate.
Devices Used: Amplatzer™ PFO Occluder and Amplatzer™ Talisman™ PFO Occluder
Number of patients needed: 1,214
Long-term follow up: 5 years after receiving the device.
CLOSE trial²
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.