RESPECT Clinical Trial
The RESPECT trial demonstrated that PFO closure with
the AMPLATZER PFO Occluder was more effective
than medical management in preventing recurrent
cryptogenic stroke in patients with a PFO.
RESPECT Clinical Trial
The RESPECT Clinical Trial is a randomized clinical research study required by the Food and Drug Administration (FDA) that compares the effectiveness and safety of the AMPLATZER PFO Occluder closure device to treatment with blood thinners.
How was the RESPECT Clinical Trial conducted?
Participants in the RESPECT Trial had been diagnosed with a cryptogenic stroke and a PFO. Participants were randomly assigned to one of two groups. One group received the AMPLATZER PFO Occluder plus medical management. The other group did not receive the device, and instead followed the standard of care medical management, which meant receiving blood-thinning medicine alone to potentially decrease the risk of another stroke. Each patient’s physician decided which type and amount of medicine was the best treatment plan for them. Patients had regularly scheduled appointments with their physician throughout the duration of the clinical trial to determine their progress.
Who participated in the study?
Study participants were between the ages of 18-60 years of age, with an average age of 46 when they were enrolled in the study. Participants agreed to continue to be followed in the study at specific time frames for as long as the study lasted.
What are the results of the RESPECT Clinical Trial?
Over the past eight years, 980 patients have participated in the RESPECT clinical trial, equating to over 2,300 patient years of clinical data. The data that was collected has been reviewed by an independent clinical research group to determine the meaning behind the data that was collected on each patient. The RESPECT trial found that patients that received the AMPLATZER PFO Occluder had a 46.6-72.7% risk reduction in recurrent cryptogenic stroke over those that were only on medical therapy.
The AMPLATZER™ PFO Occluder from St. Jude Medical
- Only PFO closure device used in the St. Jude Medical RESPECT trial.
- Only PFO closure device clinically proven to reduce the risk of recurrent stroke1
- Proven device performance through extensive clinical experience of over 60,000 devices implanted worldwide2
- Minimally invasive closure of patent foramen ovale allows most patients to return home within 24 hours of the procedure
- Data on file at St. Jude Medical.
- Data on File at St Jude Medical, number of implants as of March, 2011.