Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorLifetech Scientific (Shenzhen) Co., Ltd.
About this trial
To evaluate the performance of Cera™ patent foramen ovale occluders developed by Lifetech Scientific (Shenzhen) Co., LTD;
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 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);
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Cera™ patent foramen ovale occluders
DevicePatients 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
DevicePatients 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).
Treatment groups
244 Participants
are divided into 2 treatment groupsGroup A: Cera™ patent foramen ovale occludersExperimental treatment 1 intervention
Group B: Another patent foramen ovale occludersActive comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
180 days after surgerySecondary outcomes
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.
Time frame
7 days after surgery2
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.
Time frame
7 days after surgery3
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.
Time frame
180 days after surgery4
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.
Time frame
360 days after surgerySponsors and contacts
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Source ClinicalTrials.gov