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AMPLATZER PFO Occluder Post Approval Study

NCT03309332 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1214

Last updated 2026-03-11

No results posted yet for this study

Summary

The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZER™ PFO Occluder in the post Approval Setting.

Conditions

Interventions

DEVICE

AMPLATZER™ PFO Occluder

Implantation of the AMPLATZER™ PFO Occluder in the PFO

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Barathi Sethuraman, PhD · Abbott

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-31
Primary Completion
2030-02-05
Completion
2030-02-05
FDA Device
Yes

Countries

  • United States
  • Canada
  • Germany
  • Italy
  • Portugal
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03309332 on ClinicalTrials.gov