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Safety and Effectiveness Study of the Solysafe Septal Occluder in Patients With Atrial Septum Defect and Patent Foramen Ovale

NCT00207376 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL

Last updated 2009-06-24

No results posted yet for this study

Summary

This is a prospective multicenter clinical study to evaluate the safety and effectiveness of an intracardiac septal closure device in patients with atrial septum defect (ASD) and patent foramen ovale (PFO).

Conditions

  • Atrial Septal Defect
  • Patent Foramen Ovale

Interventions

DEVICE

Solysafe Septal Occluder

Sponsors & Collaborators

  • Carag AG

    lead INDUSTRY

Principal Investigators

  • Peter Ewert, PD Dr. · German Heart Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Germany

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 NCT00207376 on ClinicalTrials.gov