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

This study has been completed.
Sponsor:
Collaborator:
MDT Medical Device Testing GmbH
Information provided by:
pfm medical ag
ClinicalTrials.gov Identifier:
NCT00968032
First received: August 27, 2009
Last updated: May 30, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Foramen Ovale, Patent
Heart Catheterization
Heart Septal Defects, Atrial
Device: Nit-Occlud® PFO

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Further study details as provided by pfm medical ag:

Primary Outcome Measures:
  • Number of Participants With a Successful Implantation. [ Time Frame: 6 weeks ± 2 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 63
Study Start Date: July 2009
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Nit-Occlud® PFO
    Transcatheter implantation of a PFO occluder (Nitinol double Umbrella)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00968032

Locations
Germany
Cardio-Vascular Centre, Sankt Kathrinen
Frankfurt, Germany, 60389
Sponsors and Collaborators
pfm medical ag
MDT Medical Device Testing GmbH
Investigators
Principal Investigator: Horst Sievert, Prof. Dr. Cardio-Vascular Centre, Sankt Kathrinen, Frankfurt, Germany
  More Information

No publications provided

Responsible Party: Christof Schmeer head of quality assurance pfm group, pfm medical ag
ClinicalTrials.gov Identifier: NCT00968032     History of Changes
Other Study ID Numbers: 09k003
Study First Received: August 27, 2009
Results First Received: January 27, 2011
Last Updated: May 30, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by pfm medical ag:
PFO
Patent Foramen Ovale

Additional relevant MeSH terms:
Foramen Ovale, Patent
Heart Septal Defects
Heart Septal Defects, Atrial
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 26, 2014