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Tests treatment safety and results for Patent Foramen Ovale
Official title Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.
ClinicalTrials.gov ID: NCT05774288
What this study is testing
- What it's testing
- To evaluate the performance of Cera™ patent foramen ovale occluders developed by Lifetech Scientific (Shenzhen) Co., LTD;
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join 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);
You likely can't join 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 \ 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...
See the full eligibility criteria
- 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.
- 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 \ 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Meizhou, Guangdong, China
- Changsha, Hunan, China
- Changchun, Jilin, China
- Shenyang, Liaoning, China
- Jinan, Shandong, China
- Kunming, Yunnan, China
- Hangzhou, Zhejiang, China
- Ningbo, Zhejiang, China
- Wenzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Meizhou, Guangdong, China; Changsha, Hunan, China; Changchun, Jilin, China; Shenyang, Liaoning, China and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.