Cera™ VSD Occluder Post Market Clinical Follow-up

NCT ID: NCT05939713

Last Updated: 2025-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

152 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-13

Study Completion Date

2025-03-04

Brief Summary

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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

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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.

Conditions

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Ventricular Septal Defect

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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VSD subjects

Patients with a confirmed diagnosis of Ventricular Septal Defect (VSD) and implanted with the Cera VSD occluder as per IFU instructions

Cera™ VSD occluder implantation

Intervention Type DEVICE

To collect data from patients who have implanted with the device before 2022.

Interventions

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Cera™ VSD occluder implantation

To collect data from patients who have implanted with the device before 2022.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardiac Children's Foundation Taiwan

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jou-Kou Wang

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Site Status

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Taipei Mackay Memorial Hospital

Taipei, , Taiwan

Site Status

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

Linkou Chang-Gung Memorial Hospita

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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LT/TS/29I-01N-01

Identifier Type: -

Identifier Source: org_study_id

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