Suitable for occlusion of patent foramen ovale in congenital heart disease
Conditions
Interventions
Experimental group: Fully degradable patent foramen ovale occluder system:Using the fully degradable patent foramen ovale occluder system developed and produced by Shanghai Jinsi Medical Equipment Tec
Control group: Metal occluder:Use metal occluder System
Sponsors
The First Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Participants in the experiment are aged between 18 and 60 years old (inclusive); 2. Imaging examination confirms the presence of patent foramen ovale and moderate to large right to left shunting: a) Echocardiography (TTE or TEE) confirms the presence of patent foramen ovale (PFO); b) Contrast enhanced ultrasound (cTTE or cTEE or cTCD) confirms the presence of moderate to large right to left shunting (RLS); 3. After clinical judgment and exclusion of other causes, diagnosed as PFO related stroke; 4. The participants or their guardians are able to understand the purpose of the experiment, voluntarily participate, and sign a written informed consent form. Note: The grading standards for ultrasound contrast imaging are attached. PFO related stroke is defined as an ischemic stroke involving the cortex, multiple softening/ischemic lesions, white matter lesions, or retinal infarction in the presence of patent foramen ovale and no other clear etiology has been identified.
Exclusion criteria
Exclusion criteria: 1. Researchers have determined that non PFO related causes of ischemic stroke can be identified; Large area cerebral infarction occurs within 2.4 weeks; 3. Intracardiac thrombosis or tumor, intracardiac vegetations; Acute myocardial infarction within 4.3 months; 5. Existence of left ventricular aneurysm or left ventricular wall motion disorder; 6. Concurrent severe valve disease, such as severe mitral regurgitation or stenosis, severe aortic regurgitation or stenosis, mitral or aortic valve vegetations; 7. Combination of dilated cardiomyopathy and hypertrophic cardiomyopathy; 8. Combined with severe heart failure, LVEF3 times the upper limit of normal, or serum creatinine (Cr)>2 times the upper limit of normal); 15. Coagulation dysfunction diseases with bleeding tendency or contraindications to antiplatelet/anticoagulant therapy determined by researchers; 16. Pregnant or lactating women; 17. The researchers determined that the structure of the patent foramen ovale in the trial participants was not suitable for implantation of occluders or had contraindications for patent foramen ovale occlusion; 18. Merge other cardiac malformations that require cardiac surgery; 19. Currently participating in other clinical trials that have not yet reached the trial endpoint; 20. Other situations that the researchers believe are not suitable for participating in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transthoracic echocardiography;Occlusion success rate? 12 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Instrument success rate;Surgery success rate; | — |
Countries
China
Contacts
Public ContactYuan Bai
The First Affiliated Hospital of Naval Medical University
Outcome results
None listed