The Effect of Device Closure of Patent Foramen Ovale in Elderly Patients With Crytogenic Stoke/TCI

NCT01018355 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2010-05-06

No results posted yet for this study

Summary

The primary objective is to evaluate if patent foramen ovale (PFO) closure and antiplatelet medical management can reduce the risk of recurrent stroke or transient ischemic attack (TIA) when compared to antiplatelet medical management alone in elderly patients above 50 years of age with a PFO and a history of cryptogenic stroke or TIA.

Conditions

  • Patent Foramen Ovale
  • PFO
  • Stroke
  • TIA

Interventions

DEVICE

Percutaneous device closure of patent foramen ovale

Percutaneous device closure of patent foramen ovale

Sponsors & Collaborators

  • Hillerod Hospital, Denmark

    lead OTHER

Principal Investigators

  • Christian S Hansen, dr. · Hillerød Hospital. dept. of cardiology and endocrinology

  • Niels Tønder, Dr. · Hillerød Hospital. dept. of cardiology and endocrinology

  • Kasper K Iversen, Dr. · Hillerød Hospital. dept. of cardiology and endocrinology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
51 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-09-30
Completion
2015-06-30

Countries

  • Denmark

Study Locations

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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 NCT01018355 on ClinicalTrials.gov