BEGIN YOUR JOURNEY TOWARDS PREVENTING CRYPTOGENIC STROKE
If you’ve had a stroke due to an unknown cause, learn how you may be able to prevent another with the Amplatzer™ PFO Occluder.
Current selected region:
UNITED STATES
The RESPECT Trial
The leading device, the landmark trial and a turning point for PFO closure
The Amplatzer™ PFO Occluder, the leading PFO closure device, demonstrated excellent safety and efficacy in reducing the risk of recurrent stroke in the largest PFO trial ever conducted.
The landmark RESPECT Trial¹
Most patients studied
The RESPECT trial is the largest clinical trial evaluating patent foramen ovale (PFO) closure.
Most extensive follow-up
The trial spanned 13 years, collecting over 5,810 patient-years of data.
Patient benefits¹
The Amplatzer™ PFO Occluder significantly lowers the risk of recurrent ischemic stroke.
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.
Rigorous PFO trial
Broad inclusion criteria, with most 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 and the prevention of recurrent ischemic stroke.
- The trial enrolled 980 patients at 69 medical centers across the U.S. and Canada
- 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
Safety: No device embolization, aortic erosion/dissection, device thrombus
Data from the closure group of the RESPECT trial showed low rates of Serious Adverse Events (SAEs), including no incidence of embolization, aortic erosion/dissection, thrombus formation and low risk of serious atrial fibrillation, consistent with medical therapy.¹
Efficacy: significantly reduced risk of recurrent stroke¹
The trial also demonstrated a 45% relative risk reduction for any recurrent ischemic stroke over nearly six years of follow-up with the use of the Amplatzer™ PFO Occluder¹
The RESPECT trial showed that there was a 62% relative risk reduction for recurrent cryptogenic stroke with the use of the Amplatzer™ PFO Occluder¹
Consistency: Excellent procedural results¹
94.2% effective PFO closure (n≤9 bubbles at 6 months). Patients measured after only 6 months demonstrated freedom from shunt at both rest and Valsalva.
In the RESPECT Trial, the Amplatzer™ PFO Occluder demonstrated 99.1% technical success.²*
In the RESPECT Trial, the Amplatzer™ PFO Occluder demonstrated 96.1% procedural success with excellent effective closure.²**
Find out more about the Amplatzer™ PFO Occluder and the PFO closure 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.
- Carroll et al (2013). Closure of Patent Foramen Ovale versus Medical Therapy after Cryptogenic Stroke. N Engl J Med 368;12 nejm.1092 org