RecruitingNot Applicable

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

Brazil145 participantsStarted 2024-07-09

Plain-language 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.

Who can participate

SexALL

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Inclusion criteria

✓. 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.

What they're measuring

Procedural success

Timeframe: 6 months post-implantation

Trial details

NCT IDNCT05887700

SponsorLifetech Scientific (Shenzhen) Co., Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-12

Contact for this trial

Rae Gong, PM

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

View on ClinicalTrials.gov More Atrial Septal Defect trials