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Procedural Success and Safety of the Nit-Occlud® Patent Foramen Ovale (PFO) Closure Device and Its Application System (09k003)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00968032
Recruitment Status : Completed
First Posted : August 28, 2009
Results First Posted : March 9, 2011
Last Update Posted : June 2, 2011
MDT Medical Device Testing GmbH
Information provided by:
pfm medical ag

Tracking Information
First Submitted Date  ICMJE August 27, 2009
First Posted Date  ICMJE August 28, 2009
Results First Submitted Date  ICMJE January 27, 2011
Results First Posted Date  ICMJE March 9, 2011
Last Update Posted Date June 2, 2011
Study Start Date  ICMJE July 2009
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2011)
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 Measures  ICMJE
 (submitted: August 27, 2009)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Procedural Success and Safety of the Nit-Occlud® Patent Foramen Ovale (PFO) Closure Device and Its Application System
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Foramen Ovale, Patent
  • Heart Catheterization
  • Heart Septal Defects, Atrial
Intervention  ICMJE Device: Nit-Occlud® PFO
Transcatheter implantation of a PFO occluder (Nitinol double Umbrella)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2010)
Original Estimated Enrollment  ICMJE
 (submitted: August 27, 2009)
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Diagnosis of patent foramen ovale (PFO)

  1. Age between 18 and 65 years of both gender
  2. 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
  3. Signed informed consent
  4. 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
  5. 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
  6. 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.

Exclusion Criteria:

  1. PFO dimensions exceeding Inclusion criterium 5)
  2. Active endocarditis
  3. Presence of an infectious disease
  4. Vascular anatomy unable to accommodate the appropriate-sized sheath for device introduction
  5. Current arrhythmia, or history of arrhythmia
  6. Prior cardiac surgery, including implantation of active and non-active cardiac device (coronary stent is allowed)
  7. Confinement to bed (because of higher potential for clot formation)
  8. Heart abnormality other than PFO
  9. Accessory atrial defects
  10. Participation in an investigational drug or device trial within 30 days prior to selection, or current inclusion in any other clinical trial or research project
  11. Known allergy to nickel
  12. Known allergy to contrast agents
  13. Cancerogenic disease or malignant tumor, or other severe disease
  14. Intracardiac mass or vegetation
  15. Thrombus at the intended site of implant or documented evidence of venous thrombus in the vessel to which access to the defect is gained
  16. Unable to tolerate Aspirin or Clopidogrel, and/or antibiotic prophylaxis for at least three months following the procedure
  17. Pregnant or breast feeding female patients
  18. Subjects who, in the opinion of the investigator, will be inappropriate for inclusion into this trial or will not comply with requirements of the study
  19. Subjects who are imprisoned (according to MPG § 20.3)
  20. Patients who are lawfully kept in an institution
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00968032
Other Study ID Numbers  ICMJE 09k003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christof Schmeer head of quality assurance pfm group, pfm medical ag
Study Sponsor  ICMJE pfm medical ag
Collaborators  ICMJE MDT Medical Device Testing GmbH
Investigators  ICMJE
Principal Investigator: Horst Sievert, Prof. Dr. Cardio-Vascular Centre, Sankt Kathrinen, Frankfurt, Germany
PRS Account pfm medical ag
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP