NCT05887700

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Jul 2024

Typical duration for all trials

Geographic Reach
3 countries

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Jul 2024Dec 2027

First Submitted

Initial submission to the registry

May 24, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 9, 2024

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

3.4 years

First QC Date

May 24, 2023

Last Update Submit

January 6, 2025

Conditions

Atrial Septal Defect

Keywords

LifetechAtrial Septal DefectASDCeraFlexASD Closure System

Outcome Measures

Primary Outcomes (1)

  • Procedural success

    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 Outcomes (5)

  • Incidence of moderate or large residual shunt

    At procedure, 6 months and 12 months post-implantation

  • Incidence of device or procedure related Adverse Events (AEs)

    From attempted procedure to 24 months post-implantation

  • Incidence of device or procedure related Serious Adverse Events (SAEs)

    From attempted procedure to 24 months post-implantation

  • Incidence of Device Deficiencies (DD)

    From attempted procedure to 24 months post-implantation

  • Incidence of death

    From attempted procedure to 24 months post-implantation

Study Arms (1)

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

Interventions

CeraFlex™ Atrial Septal Defect (ASD) Closure SystemDEVICE

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.

ASD subjects

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hospital Pequeno Príncipe

Curitiba, Brazil

NOT YET RECRUITING

Universidade Federal do Ceará

Fortaleza, Brazil

NOT YET RECRUITING

Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Brazil

NOT YET RECRUITING

HCOR - Associação Beneficente Síria

São Paulo, Brazil

NOT YET RECRUITING

Hospital Beneficência Portuguesa

São Paulo, Brazil

NOT YET RECRUITING

Onassis Cardiac Surgery Center

Kallithea, Greece

RECRUITING

IRCCS Policlinico San Donato

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Heart Septal Defects, Atrial

Condition Hierarchy (Ancestors)

Heart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Rae Gong, PM

CONTACT

(86-755)-86026250-6957gongrui@lifetechmed.com

KaDirr Shemsi, APM

CONTACT

+86-176-2130-9203KaDirr@lifetechmed.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2023

First Posted

June 5, 2023

Study Start

July 9, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 8, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)IT(1)BR(5)