Tests Cera occluder device for patent foramen ovale in people with cryptogenic stroke
Compares the Cera heart device with another device for a small heart opening, in adults.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.
Key facts
- Where
- Beijing, Changchun, Changsha, Guangzhou, Hangzhou, Jinan, Kunming, Meizhou, Ningbo, Shenyang, and Wenzhou, ChinaSee the 14 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT05774288, who can take part
Where in China
- Fuwai Hospital ，CAMS&PUMCBeijing, ChinaNot yet recruiting
- Peking University First HospitalBeijing, ChinaNot yet recruiting
- The First Hospital Of JiLin UniversitvChangchun, ChinaNot yet recruiting
- The Second Xiangya Hospital of Central South UniversityChangsha, ChinaTaking people
- The Third Xiangya Hospital of Central South UniversityChangsha, ChinaTaking people
- The First Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, ChinaTaking people
- Zhejiang Provincial People's HospitalHangzhou, ChinaTaking people
- Qilu Hospitalof Shandong UniversityJinan, ChinaNot yet recruiting
- The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)Jinan, ChinaNot yet recruiting
- Fuwai Yunnan Cardiovascular HospitalKunming, ChinaTaking people
- Meizhou People HospitalMeizhou, ChinaTaking people
- The First Affiliated Hospital of Ningbo UniversityNingbo, ChinaNot yet recruiting
- General Hospital of Northern Theater CommandShenyang, ChinaNot yet recruiting
- The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Trial code
- NCT05774288
- Record updated
- 1 September 2023
- Original description
To evaluate the performance of Cera™ patent foramen ovale occluders developed by Lifetech Scientific (Shenzhen) Co., LTD;Read full original descriptionShow less
A Prospective, Multi-center, Randomized, Controlled Non-inferiority Clinical Trial to Evaluate the Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.
To evaluate the performance of Cera™ patent foramen ovale occluders developed by Lifetech Scientific (Shenzhen) Co., LTD;
Inclusion: Patients aged 18-60 years; Be able to understand the purpose of the experiment, voluntarily participate in the experiment and sign the informed consent; Patent foramen ovale was confirmed by at least one of the following conditions exists:; Patent foramen ovale was confirmed by Transthoracic echocardiography (TTE) or Transesophageal echocardiography (TEE); The presence of medium or large right-to-left shunt was confirmed by Right-heart acoustic contrast (cTTE or cTCD); It meets the clinical status of patent foramen ovale plugging indication, and at least one of the following conditions exists:; Cryptogenic stroke complicated with patent foramen ovale, combined with one or more clinical risk factors; Cryptogenic stroke complicated with patent foramen ovale, combined with one or more anatomical risk factors of patent foramen ovale; Cryptogenic stroke complicated with patent foramen ovale, with clear deep vein thrombosis or pulmonary embolism, and not suitable for anticoagulant therapy; Cryptogenic stroke complicated with patent foramen ovale, but still recurred with antiplatelet or anticoagulant therapy.
Exclusion: 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; Participate in clinical trials of other drugs or medical devices within three months; Patients with intracardiac thrombosis or tumor, intracardiac vegetations; Acute myocardial infarction or unstable angina within 6 months; Left ventricular aneurysm formation or left ventricular wall movement disorder; Patients with active endocarditis or other untreated infections or other hemorrhagic diseases; Pulmonary hypertension or patent foramen ovale was a special channel; Uncontrolled hypertension (> 180/100 mmHg); Contraindication of antiplatelet or anticoagulant therapy, such as severe bleeding within 3 months, obvious retinopathy, history of other intracranial bleeding, and obvious intracranial diseases; Coronary heart disease, hypertension, diabetes and other vascular diseases that are poorly controlled by drugs or other means; Thrombosis exists at the location or route of implantation; Malignant neoplasms or other diseases with a life expectancy of less than 2 years; Dilated cardiomyopathy, LVEF < 35%, or other severe heart failure; 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); Carotid atherosclerotic stenosis was determined by the investigator based on CT or vascular ultrasound (> 50%); 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); Patients with right-to-left shunt due to other causes, including atrial septal defect or perforated diaphragm; Atrial fibrillation/atrial flutter (chronic or intermittent); Pregnant or planning to become pregnant during the trial; 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; Patients who could not be followed up during the trial.