Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.

Launched by LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. · Mar 15, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medical device called the Cera™ patent foramen ovale (PFO) occluder, which is designed to help close a small opening in the heart known as a patent foramen ovale. This opening can sometimes lead to problems like cryptogenic stroke, where the cause of the stroke is unknown. The goal of the trial is to see how safe and effective this device is for patients who have certain risk factors related to their PFO and have experienced a stroke.

To participate in this trial, you need to be between the ages of 18 and 60 and have a confirmed patent foramen ovale diagnosed through specific heart imaging tests. You should also be willing to give your consent to take part in the study. It's important to note that there are certain health conditions that may prevent you from participating, such as serious heart problems or recent strokes. If you join the trial, you will be monitored closely to see how well the device works and to ensure your safety throughout the study.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patients aged 18-60 years;
• • 2. Be able to understand the purpose of the experiment, voluntarily participate in the experiment and sign the informed consent;
• 3. Patent foramen ovale was confirmed by at least one of the following conditions exists:
• • 1. Patent foramen ovale was confirmed by Transthoracic echocardiography (TTE) or Transesophageal echocardiography (TEE);
• • 2. The presence of medium or large right-to-left shunt was confirmed by Right-heart acoustic contrast (cTTE or cTCD);
• 4. It meets the clinical status of patent foramen ovale plugging indication, and at least one of the following conditions exists:
• • 1. Cryptogenic stroke complicated with patent foramen ovale, combined with one or more clinical risk factors;
• • 2. Cryptogenic stroke complicated with patent foramen ovale, combined with one or more anatomical risk factors of patent foramen ovale;
• • 3. Cryptogenic stroke complicated with patent foramen ovale, with clear deep vein thrombosis or pulmonary embolism, and not suitable for anticoagulant therapy;
• • 4. Cryptogenic stroke complicated with patent foramen ovale, but still recurred with antiplatelet or anticoagulant therapy.
• Exclusion Criteria:
• • 1. Carotid atherosclerotic stenosis was determined by the investigator based on CT or vascular ultrasound (\> 50%);
• • 2. Large cerebral infarction occurred within 4 weeks (MR/CT or DWI image ASPECTS score \<6 points or infarction volume ≥70 ml or infarction area \> 1/3 middle cerebral artery blood supply area);
• • 3. Patients with intracardiac thrombosis or tumor, intracardiac vegetations;
• • 4. Acute myocardial infarction or unstable angina within 6 months;
• • 5. Left ventricular aneurysm formation or left ventricular wall movement disorder;
• • 6. Mitral/aortic disease: including mitral stenosis or severe mitral regurgitation of any cause, severe aortic stenosis or severe aortic regurgitation, mitral or aortic valve vegetations or prior valve replacement surgery;
• • 7. Dilated cardiomyopathy, LVEF \< 35%, or other severe heart failure;
• • 8. Patients with right-to-left shunt due to other causes, including atrial septal defect or perforated diaphragm;
• • 9. Atrial fibrillation/atrial flutter (chronic or intermittent);
• • 10. Pregnant or planning to become pregnant during the trial;
• • 11. Patients with active endocarditis or other untreated infections or other hemorrhagic diseases;
• • 12. Pulmonary hypertension or patent foramen ovale was a special channel;
• • 13. Liver and kidney function impairment (ALT or AST \> 3 times the upper limit of normal value, serum creatinine (Cr) \> 2 times the upper limit of normal value);
• • 14. Uncontrolled hypertension (\> 180/100 mmHg);
• • 15. Contraindication of antiplatelet or anticoagulant therapy, such as severe bleeding within 3 months, obvious retinopathy, history of other intracranial bleeding, and obvious intracranial diseases;
• • 16. Coronary heart disease, hypertension, diabetes and other vascular diseases that are poorly controlled by drugs or other means;
• • 17. The investigator determined that the patient was not suitable for implantation of PFO occluder (for example, the diameter of the base of the atrial septal tumor ≥25mm and the size of the foramen ovale ≥5mm) or the patient has contraindications for implantation of PFO occluder;
• • 18. Thrombosis exists at the location or route of implantation;
• • 19. Malignant neoplasms or other diseases with a life expectancy of less than 2 years;
• • 20. Patients who could not be followed up during the trial;
• • 21. Participate in clinical trials of other drugs or medical devices within three months.