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

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.

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.

Study Overview

• Status: Completed
• Conditions: Heart Septal Defects, Atrial; Foramen Ovale, Patent; Heart Catheterization
• Intervention / Treatment: Device: Nit-Occlud® PFO

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Frankfurt, Germany, 60389
    • Cardio-Vascular Centre, Sankt Kathrinen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: pfm medical ag
• Collaborators: MDT Medical Device Testing GmbH
• Investigators: Principal Investigator: Horst Sievert, Prof. Dr., Cardio-Vascular Centre, Sankt Kathrinen, Frankfurt, Germany

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: August 27, 2009
• First Submitted That Met QC Criteria: August 27, 2009
• First Posted (Estimate): August 28, 2009

Study Record Updates

• Last Update Posted (Estimate): June 2, 2011
• Last Update Submitted That Met QC Criteria: May 30, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: Patent Foramen Ovale; PFO
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects; Heart Septal Defects, Atrial; Foramen Ovale, Patent
• Other Study ID Numbers: 09k003