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

NCT00968032 | Completed Results

• 1 other identifier: 09k003
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

PFO; Patent Foramen Ovale

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Successful Implantation.

  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.

  6 weeks ± 2 weeks

Interventions

Nit-Occlud® PFO DEVICE

Transcatheter implantation of a PFO occluder (Nitinol double Umbrella)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of patent foramen ovale (PFO)
• Age between 18 and 65 years of both gender
• Ability to give written informed consent after being told the potential benefits and risks of entering the trial to understand the planned clinical study and able to participate in all follow-up procedures
• Signed informed consent
• Presenting with neurological symptoms and at least one of the following clinical circumstances:
• Diagnosis of cryptogenic stroke based on clinical neurological examination
• Diagnosis of a transient ischemic attack (TIA) based on clinical neurological examination
• PFO defect with or without atrial septal aneurysm of a balloon stretched diameter less than 18 mm. PFO tunnel length less than 10 mm in TEE
• Mental and physical ability of patient to follow the protocol according to compliance to time schedule, treatment plan,completion of CRF pages and further study procedures.

You may not qualify if:

• Active endocarditis
• Presence of an infectious disease
• Vascular anatomy unable to accommodate the appropriate-sized sheath for device introduction
• Current arrhythmia, or history of arrhythmia
• Prior cardiac surgery, including implantation of active and non-active cardiac device (coronary stent is allowed)
• Confinement to bed (because of higher potential for clot formation)
• Heart abnormality other than PFO
• Accessory atrial defects
• Known allergy to nickel
• Known allergy to contrast agents
• Cancerogenic disease or malignant tumor, or other severe disease
• Intracardiac mass or vegetation
• Thrombus at the intended site of implant or documented evidence of venous thrombus in the vessel to which access to the defect is gained
• Unable to tolerate Aspirin or Clopidogrel, and/or antibiotic prophylaxis for at least three months following the procedure
• Pregnant or breast feeding female patients

Sponsors & Collaborators

• pfm medical gmbh: lead
• MDT Medical Device Testing GmbH: collaborator

Study Sites (1)

Cardio-Vascular Centre, Sankt Kathrinen

Frankfurt, 60389, Germany

Location

MeSH Terms

Conditions

Foramen Ovale, Patent; Heart Septal Defects, Atrial

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Christof Schmeer
• Organization: pfm medical ag

christof.schmeer@pfmmedical.com

+49 6873 9011

Study Officials

• Horst Sievert, Prof. Dr.

  Cardio-Vascular Centre, Sankt Kathrinen, Frankfurt, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: August 27, 2009
• First Posted: August 28, 2009
• Study Start: July 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 2, 2011
• Results First Posted: March 9, 2011

Record last verified: 2011-05

Locations

DE (1)