Foramen Ovale, Patent, Heart Catheterization, Heart Septal Defects, Atrial
Conditions
Keywords
PFO, Patent Foramen Ovale
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.
Interventions
DEVICENit-Occlud® PFO
Transcatheter implantation of a PFO occluder (Nitinol double Umbrella)
Sponsors
MDT Medical Device Testing GmbH
pfm medical gmbh
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Successful Implantation. | 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. |
Countries
Germany
Participant flow
Recruitment details
The recruitment period was set between June 2009 and July 2010 at a single medical clinic.
Pre-assignment details
No enrolled participants were excluded from the trial.
Participants by arm
| Arm | Count |
|---|---|
| Nit-Occlud® PFO | 63 |
| Total | 63 |
Baseline characteristics
| Characteristic | Nit-Occlud® PFO |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 61 Participants |
| Age Continuous | 45.7 years STANDARD_DEVIATION 11.2 |
| Region of Enrollment Germany | 63 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 19 / 63 |
| serious Total, serious adverse events | 0 / 63 |
Outcome results
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.
Time frame: 6 weeks ± 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nit-Occlud® PFO | Number of Participants With a Successful Implantation. | 62 participants |