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Procedural Success and Safety of the Nit-Occlud® Patent Foramen Ovale (PFO) Closure Device and Its Application System

NCT00968032 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2011-06-02

Study results available
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Summary

The foramen ovale is an opening in the interatrial septum. It results from an incomplete coverage of the ostium secundum. In 10 to 24% of the general population incomplete fibrosis of the interatrial septum is a clinical finding and is defined as a patent foramen ovale (PFO). The Nit-Occlud® PFO umbrella is a permanent implant for closing PFOs that is implanted in the PFO using minimally invasive catheter technology. The umbrella is made from Nitinol, a material with superelastic properties, which, in its relaxed state, has the form of a double umbrella. This is a single-center, non-comparative, prospective interventional clinical investigation involving 1 center in Germany to assess the effectiveness, safety and practicability of implantation of the Nit-Occlud PFO® Closure Device.

Conditions

  • Foramen Ovale, Patent
  • Heart Catheterization
  • Heart Septal Defects, Atrial

Interventions

DEVICE

Nit-Occlud® PFO

Transcatheter implantation of a PFO occluder (Nitinol double Umbrella)

Sponsors & Collaborators

  • MDT Medical Device Testing GmbH

    collaborator INDUSTRY

  • pfm medical gmbh

    lead INDUSTRY

Principal Investigators

  • Horst Sievert, Prof. Dr. · Cardio-Vascular Centre, Sankt Kathrinen, Frankfurt, Germany

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-05-31
Completion
2010-06-30

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 NCT00968032 on ClinicalTrials.gov