Study 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.
- Patent Foramen Ovale
- Stroke
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
2 Primary · 0 Secondary · Reporting Duration: Through 5 years
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
1 Treatment Group
Device
1 of 1
Experimental Treatment
1214 Total Participants · 1 Treatment Group
Primary Treatment: AMPLATZER™ PFO Occluder · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 60 · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you: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." - Anonymous Online Contributor
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)." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor