Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up

April 11, 2024 updated by: Lifetech Scientific (Shenzhen) Co., Ltd.

A Multi-center, Single-arm, Real-world Registry Assessing the Clinical Use of the Lifetech CeraFlex™ ASD Closure System

The objective of this post-market registry is to assess the clinical use of the Lifetech CeraFlex™ Closure System in a real-world and on-label fashion.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The study intends to collect data from patients who have implanted with the device between 2019 and 2022. The data collection process is expected to complete by end of 2024. Final report shall be available in 2025.

Study Type

Observational

Enrollment (Estimated)

145

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • Curitiba, Brazil
        • Hospital Pequeno Principe
        • Contact:
          • Leo Solarewicz
      • Porto Alegre, Brazil
        • Santa Casa de Misericordia de Porto Alegre
        • Contact:
          • Carlo Pilla
      • São José, Brazil
        • Instituto de Cardiologia de Santa Catarina
        • Contact:
          • Luiz Giuliano
      • São Paulo, Brazil
        • Hospital Beneficência Portuguesa
        • Contact:
          • Salvador Cristóvão
      • São Paulo, Brazil
        • HCOR - Associação Beneficente Síria
        • Contact:
          • Carlos Pedra
  • Greece
  • Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device.

Description

Inclusion Criteria:

  1. Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device as per IFU instructions.
  2. Patients or legally authorized representatives have signed Data Release Consent or equivalent documents.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ASD subjects
Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device.
Device: CeraFlex™ Atrial Septal Defect (ASD) Closure System
The CeraFlex™ ASD Occluder have two types of occluders, CeraFlex™ ASD Occluder and CeraFlex™ Multi-fenestrated (Cribriform) ASD Occluder. The CeraFlex™ ASD Occluder is percutaneous, transcatheter closure devices for the non-surgical closure of atrial septal defects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural success
Time Frame: 6 months post-implantation

Procedural success is defined as a composite of:

  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.
6 months post-implantation

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of moderate or large residual shunt
Time Frame: At procedure, 6 months and 12 months post-implantation
At procedure, 6 months and 12 months post-implantation
Incidence of device or procedure related Adverse Events (AEs)
Time Frame: From attempted procedure to 24 months post-implantation
From attempted procedure to 24 months post-implantation
Incidence of device or procedure related Serious Adverse Events (SAEs)
Time Frame: From attempted procedure to 24 months post-implantation
From attempted procedure to 24 months post-implantation
Incidence of Device Deficiencies (DD)
Time Frame: From attempted procedure to 24 months post-implantation
From attempted procedure to 24 months post-implantation
Incidence of death
Time Frame: From attempted procedure to 24 months post-implantation
From attempted procedure to 24 months post-implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 24, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT-TS-271-2023-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Septal Defect

Clinical Trials on CeraFlex™ Atrial Septal Defect (ASD) Closure System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe