Patent foramen ovale
Conditions
Interventions
Trial group:Implantation of nano membrane obturator for patent foramen ovale
Control group:Implantation of cardi-o-fix patent foramen ovale occluder
Sponsors
West China Hospital,Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The age of the patients was 18-65 years old; 2) Be able to understand the purpose of the experiment, participate voluntarily and sign the informed consent form; 3) The presence of PFO was confirmed by tee or TTE; 4) Right heart contrast echocardiography (ctte) or transcranial Doppler foaming test (ctcd) confirmed the presence of moderate to large right to left shunt (calm state or after Valsalva maneuver or cough); 5) At least one of the following clinical conditions exists: a) Stroke of unknown origin complicated with PFO; e) Transient ischemic attack of unknown cause complicated with PFO; f) Recurrent migraine with PFO.
Exclusion criteria
Exclusion criteria: 1) The investigator judges that there are other clear causes of cerebral infarction or transient ischemic attack based on the patient's CT/MRI examination results and the characteristics of the medical history; 2) Intracardiac thrombus or tumor, neoplasm in the heart; 3) Acute myocardial infarction or unstable angina within 3 months; 4) Left ventricular aneurysm or dyskinesia; 5) Large area cerebral infarction within 1 month; 6) Severe bleeding diseases within 3 months, especially intracranial hemorrhage, obvious retinopathy; 7) Patients with right to left shunt caused by other reasons, including atrial septal defect and pulmonary arteriovenous fistula; 8) Patients with pulmonary hypertension or PFO as a special necessary channel; 9) Patients with active endocarditis or other systemic or local infections that have not been effectively controlled; 10) Those who are pregnant or plan to become pregnant during the trial period; 11) Malignant tumors or other diseases with life expectancy less than 2 years; 12) Those who cannot be followed up during the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful rate of effective occlusion 12 months after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of occluder implantation; | — |
Countries
China
Contacts
Public ContactNianguo Dong
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Outcome results
None listed