Patent foramen ovale (PFO) related stroke or transient ischemic attack (TIA)
Conditions
Interventions
Test group:Transcatheter patent foramen ovale suture system (Hanxin Medical Technology (Shenzhen) Co., Ltd.)
Sponsors
Shenzhen Hospital, Fuwai Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) 18-65 years old (inclusive), regardless of gender; (2) the presence of PFO; confirmed by echocardiography; (3) the presence of a large number of RLS; (4) clinically diagnosed as PFO-related stroke or TIA; (5) the subjects or their legal guardians agreed to participate in this trial and signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) according to the judgment of the researchers, any other cause of ischemic stroke or TIA could be found; (2) preoperative modified Rankin score (mRS) = 4; (3) presence of intracardiac thrombus or mass or vegetation; (4) acute myocardial infarction or unstable angina pectoris within 30 days before signing informed consent; (5) left ventricular aneurysm or left ventricular wall dyskinesia. (6) severe valvular stenosis or regurgitation, moderate or above pulmonary hypertension (mPAP > 30mmHg or PASP > 50mmHg); (7) previous valve replacement or PFO surgery; (8) dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy; (9) severe cardiac insufficiency (NYHA is III-IV) or LVEF < 35%; (10) right-to-left shunt caused by other causes, including atrial septal defect or perforated diaphragm, pulmonary arteriovenous shunt; (11) atrial fibrillation / atrial flutter; (12) active endocarditis or other untreated infectious diseases; (13) impairment of liver and kidney function (glutamic pyruvic transaminase (ALT) or glutamic oxaloacetic transaminase (AST) > 3 times the normal limit, serum creatinine (Cr) > 2 times the normal limit); (14) Thrombosis or other conditions that affect the normal use of instruments; (15) taboos on antiplatelet or anticoagulation therapy; (16) subjects with a life expectancy of less than 1 year; (17) pregnant or lactating women and those who plan to become pregnant during the trial; (18) those who come out of other clinical trials (drugs or devices) or are participating in other clinical trials within 30 days before signing the informed consent form; (19) other situations that the researchers believe are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective closure rate 360 days after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of operation;Effective closure rate 180 days after operation;Complete closure rate;PFO-related stroke / TIA recurrence rate; | — |
Countries
China
Contacts
Public ContactPan Xiangbin
Shenzhen Hospital, Fuwai Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed