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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Single-center Non-comparative, Prospective Interventional Clinical Investigation on the Procedural Success and Safety of the Nit-Occlud® PFO Closure Device and Its Application System.

Brief 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.

Detailed Summary:
Sponsor: pfm medical ag

Current Primary Outcome: Number of Participants With a Successful Implantation. [ Time Frame: 6 weeks ± 2 weeks ]

The implantation of the device under investigation in a single patient is defined as successful if delivery, placement and release of the device in a stable position is successful. The value will be compared to the number of patient enrolled.


Original Primary Outcome: Primary Outcome Measure: The primary variable measuring the procedural success is the rate of successful implantation, i.e. delivery and placement, of the device. It is a combined endpoint for each patient [ Time Frame: 6 weeks ± 2 weeks ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: pfm medical ag

Dates:
Date Received: August 27, 2009
Date Started: July 2009
Date Completion:
Last Updated: May 30, 2011
Last Verified: May 2011