Clinical trial NCT05939713: Cera™ VSD Occluder Post Market Clinical Follow-up
Official title: A Multi-center, Single Arm, Real-World Registry Assessing the Clinical Use of the Cera™ VSD Occluder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Septal Defect
Keywords: Cera VSD occluder
Observational
Retrospective
Multi-center
Lead sponsor: Cardiac Children's Foundation Taiwan
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 152
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study intends to collect data from patients who have implanted with the device before 2022

Brief summary: The objective of this post-market registry is to assess the safety and performance of the Lifetech Cera™ VSD occluder in a real-world and on-label fashion.

Detailed description: The study intends to collect data from patients who have implanted with the device before 2022. The study is expected to completed by the end of 2024.

Eligibility criteria: Inclusion Criteria:

* Patients with a confirmed diagnosis of Ventricular Septal Defect (VSD) and implanted with the investigational device as per IFU instructions

Exclusion Criteria:

* Patients did not conduct any follow up visit after hospital discharge.

Primary outcomes:
measure: Procedural success
timeFrame: 6 months post-implantation
Secondary outcomes:
measure: Incidence of moderate or large residual shunt
timeFrame: at procedure, 6 months and 12 months post-implantation
measure: Incidence of new onset complete AV block (third-degree AV block) or any new onset arrhythmia needing for pacemaker implantation, or new onset left bundle branch block (LBBB);
timeFrame: from attempted procedure to 24 months post-implantation
measure: Incidence of new onset second-degree AV block
timeFrame: from attempted procedure to 24 months post-implantation
measure: Incidence of new onset severe aortic or tricuspid regurgitation
timeFrame: from attempted procedure to 24 months post-implantation
measure: Incidence of device-related thrombosis (DRT)
timeFrame: from attempted procedure to 24 months post-implantation
measure: Incidence of device embolization
timeFrame: from attempted procedure to 24 months post-implantation
measure: Incidence of device or procedure related Adverse Events (AEs)
timeFrame: from attempted procedure to 24 months post-implantation
measure: Incidence of device or procedure related Serious Adverse Events (SAEs)
timeFrame: from attempted procedure to 24 months post-implantation
measure: Incidence of Device Deficiencies (DD)
timeFrame: from attempted procedure to 24 months post-implantation
measure: Incidence of death
timeFrame: from attempted procedure to 24 months post-implantation
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang-Gung Memorial Hospita
Study officials:
affiliation: National Taiwan University Hospital
name: Jou-Kou Wang
role: PRINCIPAL_INVESTIGATOR
References: