Status:
COMPLETED
Procedural Success and Safety of the Nit-Occlud® Patent Foramen Ovale (PFO) Closure Device and Its Application System
Lead Sponsor:
pfm medical gmbh
Collaborating Sponsors:
MDT Medical Device Testing GmbH
Conditions:
Foramen Ovale, Patent
Heart Catheterization
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Diagnosis of patent foramen ovale (PFO)
- Age between 18 and 65 years of both gender
- 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
- Signed informed consent
- 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
- 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
- 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
- PFO dimensions exceeding Inclusion criterium 5)
- Active endocarditis
- Presence of an infectious disease
- Vascular anatomy unable to accommodate the appropriate-sized sheath for device introduction
- Current arrhythmia, or history of arrhythmia
- Prior cardiac surgery, including implantation of active and non-active cardiac device (coronary stent is allowed)
- Confinement to bed (because of higher potential for clot formation)
- Heart abnormality other than PFO
- Accessory atrial defects
- 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
- Known allergy to nickel
- Known allergy to contrast agents
- Cancerogenic disease or malignant tumor, or other severe disease
- Intracardiac mass or vegetation
- Thrombus at the intended site of implant or documented evidence of venous thrombus in the vessel to which access to the defect is gained
- Unable to tolerate Aspirin or Clopidogrel, and/or antibiotic prophylaxis for at least three months following the procedure
- Pregnant or breast feeding female patients
- 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
- Subjects who are imprisoned (according to MPG § 20.3)
- Patients who are lawfully kept in an institution
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00968032
Start Date
July 1 2009
End Date
June 1 2010
Last Update
June 2 2011
Active Locations (1)
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1
Cardio-Vascular Centre, Sankt Kathrinen
Frankfurt, Germany, 60389