Congenital heart disease patent foramen ovale
Conditions
Interventions
Experimental group:Implant a occluder for treatment
Sponsors
Peking University First Hospital/The First Affiliated Hospital of Xi 'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65; 2. Imaging studies confirmed the presence of Pfos accompanied by moderate to large numbers of RLS (resting and Valsalva movements), and at least one of the following clinical conditions was associated with clinical PFO occlusion: a) PFO-related stroke /TIA; b) Migraine patients who do not respond/are not responding well to medication/are unwilling to take medication; c) FO-related stroke with definite DVT or pulmonary embolism; d) Patients with oblique breathing and orthostatic hypoxemia; 3. The patient had good compliance, voluntarily participated in the experiment and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1) Cerebral embolism determined by the researchers to be of any other cause; 2) RLS caused by other causes such as atrial septal defect or perforated diaphragm and pulmonary arteriovenous shunt 3) Patients with intracardiac thrombus, tumor or intracardiac growth, and patients with thrombus in implantation location or implantation path; 4) Patients with acute myocardial infarction or unstable angina within 6 months prior to knowing; 5) Patients with left ventricular aneurysm or movement disorder; 6) Patients with mitral or aortic stenosis or severe regurgitation; Previous mitral or aortic valve replacement surgery; 7) Patients with dilated cardiomyopathy, hypertrophic cardiomyopathy or restricted cardiomyopathy; 8) Severe cardiac insufficiency or left ejection fraction LVEF 3 times the upper limit of normal, serum creatinine (Cr) > 2 times the upper limit of normal); 11) Antiplatelet or anticoagulant therapy is contraindicated, such as severe bleeding within 3 months, obvious retinopathy, history of other intracranial bleeding, and obvious intracranial diseases; 12) Allergic to nickel titanium materials in the past 13) Malignant tumours or other diseases with a life expectancy of less than one year; 14) Those who are pregnant or plan to become pregnant during the trial; 15) Participate in clinical trials of other drugs or medical devices within three months; 16) The researchers judged that PFO occluder implantation was not suitable, or there were other conditions that the researchers thought were not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of effective plugging 360 days after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate;Success rate of operation;Success rate of effective plugging 180 days after operation; | — |
Countries
China
Contacts
Public ContactWei Ma/Yushun Zhang
Peking University First Hospital/The First Affiliated Hospital of Xi 'an Jiaotong University
Outcome results
None listed