Actively Recruiting

All Genders
NCT05887700

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

Led by Lifetech Scientific (Shenzhen) Co., Ltd. · Updated on 2025-01-08

145

Participants Needed

7

Research Sites

177 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Hospital Pequeno Príncipe

Curitiba, Brazil

Not Yet Recruiting

2

Universidade Federal do Ceará

Fortaleza, Brazil

Not Yet Recruiting

3

Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Brazil

Not Yet Recruiting

4

HCOR - Associação Beneficente Síria

São Paulo, Brazil

Not Yet Recruiting

5

Hospital Beneficência Portuguesa

São Paulo, Brazil

Not Yet Recruiting

6

Onassis Cardiac Surgery Center

Kallithea, Greece

Actively Recruiting

7

IRCCS Policlinico San Donato

Milan, Italy

Actively Recruiting

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Research Team

R

Rae Gong, PM

CONTACT

K

KaDirr Shemsi, APM

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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