Cera™ ASD Occluder Post-Market Clinical Follow-Up Study
ConditionAtrial Septal Defect
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorLifetech Scientific (Shenzhen) Co., Ltd.
About this trial
The objective of this post-market study is to:
* collect real-word clinical data and confirm the long-time safety and performance of the Lifetech Cera™ ASD Occluder * identify previously unknown side-effects
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with a confirmed diagnosis of secundum Atrial Septal Defect (ASD).
Patients was implanted with the study device from 01 Jan 2020 to 31 Dec 2023 as per IFU instructions.
Patients or legally authorized representative are willing to the collection and processing of his/her data or sign the Informed Consent.
Disqualifiers
Patients who have extensive congenital cardiac anomaly which can only be adequately repaired by cardiac surgery.
Patients who have sepsis within one month prior to implantation, or any systemic infection that can't be successfully treated prior to device placement.
Patients known to have a bleeding disorder, untreated ulcer or any other contraindications to aspirin therapy, unless another anti-platelet agent can be administered for 6 months.
Patients who have demonstrated intra-cardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi).
Trial population
Patients with a confirmed diagnosis of secundum Atrial Septal Defect (ASD), who needs endovascular aortic repair.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Procedural success
1. Absence of stroke/TIA, device embolization, cardiac or vascular perforation or device/procedure related death, assessed at 6 months post-implantation. 2. Successful closure of the defects, with no, trivial or small residual shunt confirmed by Doppler echocardiography at 6 months post-implantation.
Time frame
6 months post-implantationSecondary outcomes
1
Successful closure of the defects
With no, trivial or small residual shunt confirmed by Doppler echocardiography
Time frame
at procedure, discharge（up to 2 days）and 12 months post-implantation2
Incidence of new onset arrhythmia requiring medical treatment
Include medication, intervention or surgical treatment
Time frame
From attempted procedure to 2 years post-implantation3
Incidence of device or procedure related Adverse Events (AEs)
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the study medical device and whether anticipated or unanticipated.
Time frame
From attempted procedure to 2 years post-implantation4
Incidence of device or procedure related Serious Adverse Events (SAEs)
Adverse event that led to any of the following: 1. death, 2. serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure or a body function including chronic diseases, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury, or permanent impairment to a body structure or a body function, 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment
Time frame
From attempted procedure to 2 years post-implantationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov