Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.

Recruiting now · Not applicable

Conditions studied: Patent Foramen Ovale, Cryptogenic Stroke

In brief

To evaluate the performance of Cera™ patent foramen ovale occluders developed by Lifetech Scientific (Shenzhen) Co., LTD;

Key facts

Study ID

NCT05774288

Run by

Lifetech Scientific (Shenzhen) Co., Ltd.

People needed

244

Starts

2023-06-08

Expected to finish

2029-06-30

Last updated by the study team

2023-09-01

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 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;
• 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;
• Dilated cardiomyopathy, LVEF < 35%, or other severe heart failure;
• 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;
• Patients with active endocarditis or other untreated infections or other hemorrhagic diseases;
• Pulmonary hypertension or patent foramen ovale was a special channel;
• 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);
• 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;
• 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;
• Thrombosis exists at the location or route of implantation;
• Malignant neoplasms or other diseases with a life expectancy of less than 2 years;
• Patients who could not be followed up during the trial;
• Participate in clinical trials of other drugs or medical devices within three months.

Where it is running

• Meizhou people'Hospital — Meizhou, Guangdong, China (enrolling)
• The Second XiangYa Hospital of Central South University — Changsha, Hunan, China (enrolling)
• The Third XiangYa Hospital of Central South University — Changsha, Hunan, China (enrolling)
• Fuwai Yunnan Cardiovascular Hospital — Kunming, Yunnan, China (enrolling)
• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (enrolling)
• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (enrolling)
• General Hospital of Northern Theater Command — Shenyang, Liaoning, China
• Fuwai Hospital ，CAMS&PUMC — Beijing, Beijing Municipality, China
• The First Hospital Of JiLin Universitv — Changchun, Jilin, China
• Peking University First Hospital — Beijing, Beijing Municipality, China
• Qilu Hospitalof Shandong University — Jinan, Shandong, China
• The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital) — Jinan, Shandong, China
• The First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China

Full record on ClinicalTrials.gov

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