AMPLATZER™ PFO Occluder for Patent Foramen Ovale

University of Nebraska Medical Center, Omaha, NE
Patent Foramen Ovale+1 More ConditionsAMPLATZER™ PFO Occluder - Device
18 - 60
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Patent Foramen Ovale
  • Stroke

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Through 5 years

Day 30
Primary Safety: Device or procedure related serious adverse events
Through 5 years
Primary Effectiveness: 5 year rate of recurrent ischemic stroke

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

1 of 1

Experimental Treatment

1214 Total Participants · 1 Treatment Group

Primary Treatment: AMPLATZER™ PFO Occluder · No Placebo Group · N/A

Experimental Group · 1 Intervention: AMPLATZER™ PFO Occluder · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through 5 years

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
604 Previous Clinical Trials
364,693 Total Patients Enrolled
Barathi Sethuraman, PhDStudy DirectorAbbott
1 Previous Clinical Trials
721 Total Patients Enrolled

Eligibility Criteria

Age 18 - 60 · All Participants · 0 Total Inclusion Criteria

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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

Unverified Answer

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

Unverified Answer

Is enrollment for this research endeavor still available to participants?

"Affirmative. Data housed on 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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.