Evaluating Cera™ devices for closing heart openings in stroke patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the safety and effectiveness of Cera™ patent foramen ovale occluders developed by Lifetech Scientific for patients experiencing cryptogenic stroke associated with a patent foramen ovale. It is a prospective, multi-center, randomized, controlled non-inferiority trial that requires strict adherence to the implant instructions. Participants will be monitored to determine the occluder's performance compared to other available devices.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting
• Meizhou people'Hospital
  Meizhou, Guangdong, China Recruiting
• The Second XiangYa Hospital of Central South University
  Changsha, Hunan, China Recruiting
• The Third XiangYa Hospital of Central South University
  Changsha, Hunan, China Recruiting
• Fuwai Yunnan Cardiovascular Hospital
  Kunming, Yunnan, China Recruiting
• Zhejiang Provincial People's Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Xiangbin Pan, Doctor — Fuwai Yunnan Cardiovascular Hospital
• Study coordinator: Xiangbin Pan, Doctor
• Email: xiangbin428@hotmail.com
• Phone: 13811763898

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-term outcomes after PFO closure at Severance Hospital

  This registry tests how well percutaneous PFO closure works over the long term and what factors predict residual shunt, new atrial fibrillation, or other outcomes in adults who had the procedure.

  Recruiting Yonsei University · Seoul · NCT07724171

• P3 Occluder System for closing a heart opening (PFO) after stroke

  We are testing the P3 Occluder System to see if it safely and effectively closes a patent foramen ovale in adults who had a stroke related to their heart opening.

  Recruiting Recross Cardio, Inc. · Belgrade · NCT07698951

• Percutaneous repair of the atrial septum using the P3 Occluder System for PFO closure

  This trial tests the P3 Occluder System to close a patent foramen ovale (PFO) in adults 18–65 who have had a stroke that may be linked to their PFO.

  Recruiting at 5 sites Recross Cardio, Inc. · Los Angeles, California and 4 other locations · NCT07172464

• Transcatheter closure versus medical therapy for PFO in older adults

  This tests whether closing a patent foramen ovale (PFO) with a catheter plus usual medicines prevents another unexplained (cryptogenic) stroke in people over 60 better than medicines alone.

  Recruiting Institut universitaire de cardiologie et de pneumologie de Québec, University Laval · Québec, Quebec and 1 other locations · NCT05907694

• Testing a new device for closing a heart defect related to stroke

  This study is testing a new device to close a heart defect in patients who have had a stroke to see if it works as well as other approved devices.

  Recruiting at 8 sites Encore Medical Inc. · Little Rock, Arkansas and 7 other locations · NCT05537753

• PFO-Directed Therapy for Migraines: Closing the Hole or Using a Blood Thinner

  This study tests whether closing a patent foramen ovale (PFO) plus 24 weeks of prasugrel works better for long-term migraine relief than prasugrel alone in people whose migraines improve on blood-thinning therapy.

  Recruiting Phase 3 Columbia University · New York, New York · NCT07629635

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.