Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT00968032
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 ยง 20.3)
20. Patients who are lawfully kept in an institution
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00968032
Study Brief:
Protocol Section:
NCT00968032