foramen ovale not closed
Conditions
Interventions
test group:Implantation of the Flexible Lumbar Single Rivet Ovarian Occluder System
control group:Implantation of Cardi-O-Fix Ovarian Hole Failure Occluder
Sponsors
The First Affiliated Hospital of Naval Military Medical University
Eligibility
Sex/Gender
All
Age
16 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1) Patients were aged 16-60 years old; 2)Able to understand the purpose of the trial, voluntarily participate in the trial and sign the informed consent form; 3) The presence of patent foramen ovale failure confirmed by one of the following tests: a) Transthoracic ultrasound (TTE) or transesophageal ultrasound (TEE) confirming the presence of patent foramen ovale; b) The presence of a moderate-to-massive right-to-left shunt confirmed by right heart acoustic contrast (cTTE or cTCD) at rest or after a Valsalva maneuver; 4) The presence of at least one of the following clinical conditions that fulfill the indications for closure of the patent foramen ovale: a) Cryptogenic stroke combined with patent foramen ovale closure, combined with 1 or more clinical risk factors; b) Cryptogenic stroke combined with unclosed foramen ovale, combining 1 or more anatomic risk factors for unclosed foramen ovale; c) Cryptogenic stroke combined with patent foramen ovale, with definite deep vein thrombosis or pulmonary embolism, for which anticoagulation is not indicated; d) Cryptogenic stroke combined with patent foramen ovale with recurrence despite antiplatelet or anticoagulation therapy; Migraine symptoms despite adequate pharmacologic treatment and neurology consultation did not reveal any other migraine mechanism opinion.
Exclusion criteria
Exclusion criteria: 1) Atherosclerotic stenosis of the carotid artery (>50%) as determined by the investigator based on the patient's CT or vascular ultrasound; 2)large cerebral infarction within 4 weeks (ASPECTS score 1/3 middle cerebral artery blood-supplying area); 3)intracardiac thrombus or tumor, intracardiac superfluous organisms; 4)acute myocardial infarction or unstable angina within 6 months; 5)left ventricular ventricular wall tumor formation or left ventricular wall dyskinesia; 6)mitral/aortic lesions: including mitral stenosis or severe mitral regurgitation from any cause, severe aortic stenosis or severe aortic regurgitation, mitral or aortic valve redundancy, or previous valve replacement surgery; 7)Dilated cardiomyopathy with LVEF 3 times the upper limit of normal, or serum creatinine (Cr) > 2 times the upper limit of normal); 14)uncontrolled hypertension (> 180/100 mmHg); 15)contraindication to antiplatelet or anticoagulant therapy, e.g., severe bleeding within 3 months, significant retinopathy, history of other intracranial hemorrhage, significant intracranial disease; 16)Other vascular conditions such as coronary artery disease, hypertension, or diabetes mellitus that are poorly controlled by medications or other means; 17)Patient judged by the investigator to be unsuitable for implantation of a PFO occluder or patient with contraindications to occluder implantation; 18)The presence of thrombus at the implantation site or in the implantation path; 19)malignant tumors or other diseases with a life expectancy of less than 2 years; 20)patients who cannot be followed up during the trial; 21) patients who are participating in other drug or medical device clinical trials within three months, and/or are currently participating in other clinical trials that have not reached the trial endpoint.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective blocking success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of blocker implantation techniques;Success rate of occluder implantation;Complete blocking success rate;Recurrence or incidence of cryptogenic stroke during the follow-up period; | — |
Countries
China
Contacts
Public Contactyongwen Qing
The First Affiliated Hospital of Naval Military Medical University
Outcome results
None listed