← Back to Search

PFO Occluder

AMPLATZER PFO Occluder for Patent Foramen Ovale (PFO PAS Trial)

Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Screening 3 weeks
Treatment Varies
Follow Up through 5 years
Awards & highlights

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.

Who is the study for?
This trial is for people aged 18-60 who've had a stroke linked to a heart defect called PFO within the last 547 days. They must be able to take antiplatelet therapy and commit to follow-up visits. It's not for those with uncontrolled high blood pressure, certain heart conditions, severe infections, recent serious heart events, or other identified causes of stroke.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of the AMPLATZER™ PFO Occluder device in patients after it has been approved. This device is designed to close the PFO and potentially reduce the risk of future strokes.See study design
What are the potential side effects?
Possible side effects may include discomfort at the implant site, bleeding or bruising, irregular heartbeat, allergic reactions to device materials or medications used during procedure, and risks associated with heart catheterization like blood vessel damage.

PFO PAS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Effectiveness: 5 year rate of recurrent ischemic stroke
Primary Safety: Device or procedure related serious adverse events

PFO PAS Trial Design

1Treatment groups
Experimental Treatment
Group I: DeviceExperimental Treatment1 Intervention
Subjects implanted with the AMPLATZER™ PFO Occluder.

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
640 Previous Clinical Trials
404,606 Total Patients Enrolled
Barathi Sethuraman, PhDStudy DirectorAbbott
1 Previous Clinical Trials
721 Total Patients Enrolled

Media Library

AMPLATZER™ PFO Occluder (PFO Occluder) Clinical Trial Eligibility Overview. Trial Name: NCT03309332 — N/A
Patent Foramen Ovale Research Study Groups: Device
Patent Foramen Ovale Clinical Trial 2023: AMPLATZER™ PFO Occluder Highlights & Side Effects. Trial Name: NCT03309332 — N/A
AMPLATZER™ PFO Occluder (PFO Occluder) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03309332 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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)."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~75 spots leftby Oct 2024