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AMPLATZER PFO Occluder for Patent Foramen Ovale (PFO PAS Trial)
PFO PAS Trial Summary
This trial is to confirm the safety and effectiveness of a heart device called the AMPLATZER™ PFO Occluder in people who have had the device implanted already.
PFO PAS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PFO PAS Trial Design
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Who is running the clinical trial?
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- I have not had a heart attack or unstable chest pain in the last 6 months.My heart has a weakened or bulging area.I have severe narrowing or leaking of my aortic valve.I have a heart condition that causes irregular heartbeats.I have had a stroke caused by a heart condition within the last 18 months.I have kidney, liver, or lung failure as described.My high blood pressure is not controlled by medication and is over 160/90 mmHg.I have diabetes with high blood sugar levels despite taking insulin.My blood vessels are too small for the required medical device.My doctor expects me to live more than 2 years despite my illness.The device needed for my heart condition would interfere with my heart or blood vessels.My heart's left ventricle is enlarged and pumps less effectively.I had a small stroke likely due to a blockage in a tiny blood vessel in my brain.My stroke was caused by a tear in my artery.I have a blood condition that makes my blood clot more easily.I cannot take medication to prevent blood clots.My stroke has left me with significant disabilities.You have growths or artificial valves in your heart.I do not have active endocarditis or other untreated infections.I have a blocked artery in my brain affecting more than half its width.I have a blood clot or tumor in my heart.There is proof of a blood clot in the blood vessels used to access the PFO.I need treatment for a serious mitral valve issue.You have plaques in your aortic arch that stick out more than 4mm into the blood vessel.I am either younger than 18 or older than 60 years old.You have a specific heart condition that causes blood to flow in the wrong direction.
- Group 1: Device
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the exact number of participants in this research endeavor?
"Abbott Medical Devices is responsible for executing this trial, which necessitates the recruitment of 1214 eligible patients. The study will be conducted at various medical centres including Ohio State University in Columbus and University of Nebraska Medical Center in Omaha."
Is eligibility open for this research initiative?
"This research is recruiting 1214 individuals who have experienced a stroke within the last 18 to 60 months. The key eligibility criteria involves having had an ischemic stroke in the past 547 days and presenting with a patent foramen ovale (PFO)."
Is enrollment for this research endeavor still available to participants?
"Affirmative. Data housed on clinicaltrials.gov verifies that recruiting is underway for this medical trial, which was first registered on January 31st 2018 and has been revised as recently as August 9th 2022. The team needs to collect data from 1214 participants spread across 71 different sites."
Does this medical experiment accept participants under eighty years of age?
"This trial's enrolment requirements state that participants must be between 18 to 60 years old. Concurrently, there are 39 trials for minors and 1018 studies involving patients over the age of 65."
Are there multiple medical centers conducting the trial in this urban area?
"This clinical experiment is being carried out in 71 different sites, with locations ranging from Columbus and Omaha to New york. To ensure you have the lowest possible travelling time for appointments, it is recommended that participants choose a clinic closest to them when enrolling."
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