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PC-Trial: Patent Foramen Ovale and Cryptogenic Embolism

NCT00166257 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 414

Last updated 2009-05-27

No results posted yet for this study

Summary

The purpose of this study is to compare two treatments strategies to prevent further attacks in patients who have suffered an stroke or occlusion of a major artery with no obvious reason other than a persistent small opening between the upper heart chambers

Conditions

  • Embolism, Paradoxical
  • Heart Septal Defects, Atrial

Interventions

DEVICE

Percutaneous closure of patent foramen ovale

Percutaneous implantation of an AMPLATZER® PFO Occluder

DRUG

Medical antitrhombotic treatment

Investigator's choice: Anticoagulation to INR 2.0 - 3.0 OR Aspirin 100-325 mg/d OR Clopidogrel 75-150 mg/d

Sponsors & Collaborators

  • Abbott Medical Devices

    collaborator INDUSTRY

  • Foundation for Cardiovascular Research, Zurich

    lead OTHER

Principal Investigators

  • Bernhard Meier, MD · Dept. Cardiology, University Hospital Insel, Berne, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2000-02-29
Primary Completion
2011-02-28
Completion
2011-05-31

Countries

  • Australia
  • Austria
  • Belgium
  • Switzerland

Study Locations

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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 NCT00166257 on ClinicalTrials.gov