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

This study has been completed.
Sponsor:
Information provided by:
Carag AG
ClinicalTrials.gov Identifier:
NCT00207376
First received: September 13, 2005
Last updated: June 23, 2009
Last verified: February 2007
  Purpose

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).


Condition Intervention
Atrial Septal Defect
Patent Foramen Ovale
Device: Solysafe Septal Occluder

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Further study details as provided by Carag AG:

  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • ASD
  • PFO with a medical history of cryptogenic stroke due to presumed paradoxical embolism caused by a PFO

Exclusion Criteria:

  • Criteria that exclude catheterization (e.g. size too small, disseminated intravascular coagulopathy (DIC), high risk of bleeding such as coagulation or clotting disorders)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207376

Locations
Germany
German Heart Institute
Berlin, Germany, 13353
Sponsors and Collaborators
Carag AG
Investigators
Principal Investigator: Peter Ewert, PD Dr. German Heart Institute, Berlin
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00207376     History of Changes
Other Study ID Numbers: 04k001
Study First Received: September 13, 2005
Last Updated: June 23, 2009
Health Authority: Germany: LAGetSi, Berlin

Additional relevant MeSH terms:
Foramen Ovale, Patent
Heart Septal Defects
Heart Septal Defects, Atrial
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 26, 2014