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Patent Foramen OvaleNCT05774288

Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.

A study testing Cera™ patent foramen ovale occluders and Another patent foramen ovale occluders in people with Patent Foramen Ovale and Cryptogenic Stroke, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 14 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Patent Foramen Ovale, Cryptogenic Stroke
What is being tested?
Cera™ patent foramen ovale occluders and Another patent foramen ovale occluders
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
244 participants
Where
14 sitesChina
Study dates
8 Jun 2023to 30 Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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:
Show all 10Show fewer
  • 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.

Who cannot join

  • 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;
Show all 21Show fewer
  • 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.

Trial locations and contacts

14 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xiangbin Pan, Doctor contact

13811763898

xiangbin428@hotmail.com

Hongbo Yang, Bachelor contact

14 sites in 1 country

China14 sites, 14 recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Yan Liang, 010-64008229

    Wei Ma, Doctor

    Not yet recruiting

  • Fuwai Hospital ，CAMS&PUMC

    Beijing, Beijing Municipality, 100037

    Hanlu LI, 010-68331753

    Haibo Hu, Doctor

    Not yet recruiting

  • The First Hospital Of JiLin Universitv

    Changchun, Jilin, 130021

    Fei Wang, 15804301330

    Yongsheng Gao, Master

    Not yet recruiting

  • The Second XiangYa Hospital of Central South University

    Changsha, Hunan, 410000

    Chuankun Miao, 0731-85292495

    Zhenfei Fang, Doctor

    Recruiting

  • The Third XiangYa Hospital of Central South University

    Changsha, Hunan, 410000

    Yuxia Xiang, 0731-88618931

    Zhihui Zhang, Doctor

    Recruiting

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510080

    Lei Tang, 020-87608185

    Zhongkai Wu, Doctor

    Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014

    Can Wang, 0571-85893646

    Lihong Wang, Doctor

    Recruiting

  • Qilu Hospitalof Shandong University

    Jinan, Shandong, 250012

    Bailu Wang, 18560080852

    Xinhua Gu, Doctor

    Not yet recruiting

  • The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)

    Jinan, Shandong, 250014

    Juan Yin, 15806627462

    Hongxin Li, Doctor

    Not yet recruiting

  • Fuwai Yunnan Cardiovascular Hospital

    Kunming, Yunnan, 650000

    Da Zhu, (+86) 0871-65199777

    Xiangbin Pan, Doctor

    Recruiting

  • Meizhou people'Hospital

    Meizhou, Guangdong, 514031

    Fayou Yang, 0753-2131905

    Wei Zhong, Master

    Recruiting

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, 315010

    Qingya Yang, 0574-87085034

    Huiming Chu, Master

    Not yet recruiting

  • General Hospital of Northern Theater Command

    Shenyang, Liaoning, 110015

    Hongying Zhang, 024-28897204

    Qiguang Wang, Doctor

    Not yet recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

    Huafang Chen, 0577-55579590

    Hao Zhou, Doctor

    Recruiting

Other trials in China

About this study

Official title: 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;

Read the detailed 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.

Being tested
Cera™ patent foramen ovale occluders, Another patent foramen ovale occluders
Medical subject headings
Foramen Ovale, Patent, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cera™ patent foramen ovale occludersDevice

    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 occludersDevice

    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).

Study groups in NCT05774288
Study groupRoleWhat they receive
Cera™ patent foramen ovale occludersExperimentalPatients with cryptogenic stroke complicated with patent foramen ovale will be implanted with the Cera™ patent foramen ovale occluders according to the INSTRUCTIONS for Use (IFU).
Receives: Device: Cera™ patent foramen ovale occluders
Another patent foramen ovale occludersActive comparatorPatients with cryptogenic stroke complicated with patent foramen ovale will be implanted with the Another patent foramen ovale occluders according to the INSTRUCTIONS for Use (IFU).
Receives: Device: Another patent foramen ovale occluders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 180 days after surgery

Secondary outcomes (9)

  1. 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.

    Measured: 7 days after surgery

  2. 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.

    Measured: 7 days after surgery

  3. 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.

    Measured: 180 days after surgery

  4. 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.

    Measured: 360 days after surgery

  5. 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.

    Measured: 360 days, 2 years, 3 years, 4 years, 5 years after surgery

  6. All-cause mortality rate

    All-cause death is defined as death from any cause during the follow-up period.

    Measured: 360 days, 2 years, 3 years, 4 years, 5 years after surgery

  7. Incidence of new atrial fibrillation and atrial flutter during follow-up period

    atrial fibrillation and atrial flutter

    Measured: 360 days, 2 years, 3 years, 4 years, 5 years after surgery

  8. 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.);

    Measured: 360 days, 2 years, 3 years, 4 years, 5 years after surgery

  9. 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.

    Measured: 360 days, 2 years, 3 years, 4 years, 5 years after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2023
  2. Study start8 Jun 2023
  3. Primary completion30 Apr 2025 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Non-inferiority randomized controlled clinical trial
Masking
None (open label)
Enrolment
244 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05774288
Sponsor's protocol ID
TB-CM01-P-275
Status last verified
Aug 2023
First submitted
26 Feb 2023
Last updated
1 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Cera™ patent foramen ovale occluders and Another patent foramen ovale occluders in people with Patent Foramen Ovale and Cryptogenic Stroke, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 14 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiangbin Pan, Doctor (13811763898, xiangbin428@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success rate of effective occlusion (time frame: 180 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05774288.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.

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