Procedural Success and Safety of the Nit-Occlud® Patent Foramen Ovale (PFO) Closure Device and Its Application System
Information source: pfm Produkte fuer die Medizin AG
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Foramen Ovale, Patent; Heart Catheterization; Heart Septal Defects, Atrial
Intervention: Nit-Occlud® PFO (Device)
Phase: N/A
Status: Recruiting
Sponsored by: pfm Produkte fuer die Medizin AG Official(s) and/or principal investigator(s):
Horst Sievert, Prof. Dr., Principal Investigator, Affiliation: Cardio-Vascular Centre, Sankt Kathrinen, Frankfurt, Germany
Overall contact:
Christof Schmeer, Phone: +49 06873 901141, Email: christof.schmeer@pfm-ag.de
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.
Clinical Details
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.
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Christof Schmeer, Phone: +49 06873 901141, Email: christof.schmeer@pfm-ag.de
Cardio-Vascular Centre, Sankt Kathrinen, Frankfurt 60389, Germany; Recruiting
Horst Sievert, Prof. Dr.
Horst Sievert, Prof. Dr., Principal Investigator
Additional Information
Starting date: July 2009
Ending date: April 2010
Last updated: August 27, 2009
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