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

Foramen Ovale, Patent Clinical Trial

— 09k003  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00968032
• Other study ID #: 09k003
• Status: Completed
• Phase: N/A
• First received: August 27, 2009
• Last updated: May 30, 2011
• Start date: July 2009
• Est. completion date: June 2010

Study information

• Verified date: May 2011
• Source: pfm medical ag
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Nit-Occlud® PFO
Transcatheter implantation of a PFO occluder (Nitinol double Umbrella)

Locations

Country	Name	City	State
Germany	Cardio-Vascular Centre, Sankt Kathrinen	Frankfurt

Sponsors (2)

Lead Sponsor	Collaborator
pfm medical ag	MDT Medical Device Testing GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes