NCT00968032

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: pfm medical gmbh · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	Nit-Occlud® PFO	Transcatheter implantation of a PFO occluder (Nitinol double Umbrella)

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-05-01
• Completion: 2010-06-01
• First posted: 2009-08-28
• Last updated: 2011-06-02
• Results posted: 2011-03-09

Locations

1 site across 1 country: Germany