NCT00207376

Brief 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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

June 24, 2009

Status Verified

February 1, 2007

First QC Date

September 13, 2005

Last Update Submit

June 23, 2009

Conditions

Atrial Septal DefectPatent Foramen Ovale

Interventions

Solysafe Septal OccluderDEVICE

Eligibility Criteria

Age3 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Criteria that exclude catheterization (e.g. size too small, disseminated intravascular coagulopathy (DIC), high risk of bleeding such as coagulation or clotting disorders)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Heart Institute

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Heart Septal Defects, AtrialForamen Ovale, Patent

Condition Hierarchy (Ancestors)

Heart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Peter Ewert, PD Dr.

    German Heart Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Last Updated

June 24, 2009

Record last verified: 2007-02

Locations

DE(1)