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

• ClinicalTrials.gov Identifier: NCT00968032
• Recruitment Status: Completed
• First Posted: August 28, 2009
• Results First Posted: March 9, 2011
• Last Update Posted: June 2, 2011
• Sponsor: pfm medical ag
• Collaborator: MDT Medical Device Testing GmbH
• Information provided by: pfm medical ag

Tracking Information

• First Submitted Date: August 27, 2009
• First Posted Date: August 28, 2009
• Results First Submitted Date: January 27, 2011
• Results First Posted Date: March 9, 2011
• Last Update Posted Date: June 2, 2011
• Study Start Date: July 2009
• Actual Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Procedural Success and Safety of the Nit-Occlud® Patent Foramen Ovale (PFO) Closure Device and Its Application System
• 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.
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

Device: Nit-Occlud® PFO

Transcatheter implantation of a PFO occluder (Nitinol double Umbrella)

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 3, 2010): 63
• Original Estimated Enrollment (submitted: August 27, 2009): 60
• Actual Study Completion Date: June 2010
• Actual Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT00968032
• Other Study ID Numbers: 09k003
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Christof Schmeer head of quality assurance pfm group, pfm medical ag
• Study Sponsor: pfm medical ag
• Collaborators: MDT Medical Device Testing GmbH

Investigators

• Principal Investigator: Horst Sievert, Prof. Dr.; Cardio-Vascular Centre, Sankt Kathrinen, Frankfurt, Germany

• PRS Account: pfm medical ag
• Verification Date: May 2011