Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.

Patent Foramen Ovale Clinical Trial

Official title:

A Prospective, Multi-center, Randomized, Controlled Non-inferiority Clinical Trial to Evaluate the Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05774288
• Other study ID #: TB-CM01-P-275
• Status: Recruiting
• Phase: N/A
• Start date: June 8, 2023
• Est. completion date: June 30, 2029

Study information

• Verified date: August 2023
• Source: Lifetech Scientific (Shenzhen) Co., Ltd.
• Contact: Xiangbin Pan, Doctor
• Phone: 13811763898
• Email: xiangbin428[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

The purpose of this prospective, multi-center, randomized, controlled non-inferiority clinical trial was to evaluate the safety and efficacy of Cera™ patent foramen ovale occluders developed by Lifetech Scientific (Shenzhen) Co., LTD for the treatment of cryptogenic stroke complicated with patent foramen ovale. The study required the implant to follow instructions strictly.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 244
• Est. completion date: June 30, 2029
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cryptogenic Stroke
• Foramen Ovale, Patent
• Ischemic Stroke
• Patent Foramen Ovale

Intervention

Device:
• Cera™ patent foramen ovale occluders
Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with the Cera™ patent foramen ovale occluders according to the INSTRUCTIONS for Use (IFU).
• Another patent foramen ovale occluders
Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with the Another patent foramen ovale occluders according to the INSTRUCTIONS for Use (IFU).

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Lifetech Scientific (Shenzhen) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of effective occlusion	Effective occlusion was defined as: 180 days after the surgery, Transthoracic echocardiography (TTE) showed that the position and shape of the occluder were normal, and no horizontal atrial shunt was observed. Re-examination by Contrast transthoracic echocardiography (cTTE) showed no or only a small amount of right-to-left shunt, that is, no microvesicles or less than 10 microvesicles/frame in left heart cavity after Valsalva and resting state.	180 days after surgery
Secondary	Success rate of occluder implantation technology	The success of occluder implantation technology is defined as successful intraoperative implantation of occluder and immediate Echocardiography confirmed that the shape and position of the sealing device were appropriate, no new pericardial effusion or valve regurgitation was found, and the perioperative patients survived.	7 days after surgery
Secondary	Success rate of surgical implantation of occlusion	Successful occluder implantation was defined as successful implantation of occluder and routine postoperative hospitalization that there were no serious adverse events related to surgery.	7 days after surgery
Secondary	Success rate of complete occlusion	Complete occlusion was defined as the Transthoracic echocardiography (TTE) showing occlusion 180 days after surgery The position and shape of the apparatus were normal, and no horizontal atrial shunt was observed. The results of Contrast transthoracic echocardiography (cTTE) were reviewed there was no right-to-left shunt, that is, no microbubbles in the left heart cavity after Valsalva and resting state.	180 days after surgery
Secondary	Success rate of effective occlusion	Success rate of effective occlusion was defined as: Transthoracic echocardiography (TTE) showed the position and shape of the occluder 360 days after the operation Normal condition, no horizontal atrial shunt; Reexamination by Contrast transthoracic echocardiography (cTTE) showed no or few results in other words, there were no microbubbles or less than 10 microbubbles in the left heart cavity after Valsalva and resting state.	360 days after surgery
Secondary	Recurrence or incidence of cryptogenic stroke during follow-up	Cryptogenic stroke was defined as a new focal cerebral ischemia confirmed by neuroimaging (cranial MRI or CT), which was performed After extensive vascular, cardiac, and blood evaluation, non-atherosclerotic, cardiogenic, or arteriolar obliterators were identified Cerebral infarction caused by the diagnosis of exclusion.	360 days, 2 years, 3 years, 4 years, 5 years after surgery
Secondary	All-cause mortality rate	All-cause death is defined as death from any cause during the follow-up period.	360 days, 2 years, 3 years, 4 years, 5 years after surgery
Secondary	Incidence of new atrial fibrillation and atrial flutter during follow-up period	atrial fibrillation and atrial flutter	360 days, 2 years, 3 years, 4 years, 5 years after surgery
Secondary	Incidence of device-related serious adverse events during follow-up (including device-related thrombosis, embolic stroke, and peripheral stroke)	Arterial embolism, Atrioventricular block III degree, heart abrasion, infective endocarditis, severe hemolytic anemia, etc.);	360 days, 2 years, 3 years, 4 years, 5 years after surgery
Secondary	Incidence of device defects.	Device defects refer to unreasonable risks that may endanger human health and safety under normal use of medical devices in clinical trials, such as label errors, quality problems and failures.	360 days, 2 years, 3 years, 4 years, 5 years after surgery