The RESPECT Trial
The leading device, the landmark trial, and a turning point for PFO closure
The Amplatzer™ Talisman™ PFO Occluder is built off the most studied device that demonstrated excellent safety and efficacy in reducing the risk of recurrent stroke.
The landmark RESPECT Trial¹
Most patients studied
The RESPECT trial remains the largest randomized controlled trial on PFO closure.
Most extensive follow-up
The trial spanned 13 years, collecting 5,810 patient-years of data.
The Amplatzer PFO Occluder significantly lowers the risk of recurrent ischemic stroke, as compared to medical therapy alone.
A rigorous design, demonstrating significant stroke reduction
The results of the landmark RESPECT trial—a rigorous trial evaluating PFO occlusion—were published in the September 14, 2017 issue of the New England Journal of Medicine.View published study
Rigorous PFO trial
Broad inclusion criteria, with extensive follow-up
The landmark RESPECT trial is the largest trial with the most extensive patient follow-up of any trial conducted on PFO closure to reduce the risk of recurrent ischemic stroke.
- The trial enrolled 980 patients at 69 medical centers across the U.S. and Canada
- One group underwent PFO closure plus antithrombotic medication (almost exclusively antiplatelet); the other group received antithrombotic medication only (antiplatelets or anticoagulants)
- Patients on anticoagulation therapy were not excluded from the trial
- Patients in the trial were followed for a median of 5.9 years
- The trial collected a total of 5,810 patient-years of data, more follow-up than any other PFO trial
Highlights from the RESPECT trial
Efficacy: significantly reduced risk of recurrent stroke¹
*As compared to medical therapy alone.
Consistency: Excellent procedural results¹
(n≤9 bubbles at 6 months).
Learn more about the PFO Closure Procedure with the Amplatzer™ Talisman™ PFO OccluderRead about the procedure
*Technical success = Successful delivery and release of the device.
†Procedural success = Successful implant of the device with no in-hospital serious adverse events.
- 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. doi: 10.1056/NEJMoa1610057
- Carroll JD, Saver JL, Thaler DE, et al. Closure of patent foramen ovale versus medical therapy after cryptogenic stroke. N Engl J Med. 2013;368:1092-100. doi: 10.1056/NEJMoa1301440