New heart device tested in everyday use to seal birth defects

NCT ID NCT05887700

Recruiting now Disease control Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is tracking 145 people who have a hole in their heart (atrial septal defect) and received the CeraFlex closure device. Researchers want to see how well the device works in real-world settings, focusing on safety and successful closure of the hole at 6 months. The device is implanted through a tube in a blood vessel, avoiding open-heart surgery.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: CeraFlex ASD closure device (a heart implant that closes a hole in the heart wall)
What this could lead to: If successful, this registry could confirm that the CeraFlex device is a safe and effective option for closing atrial septal defects without open-heart surgery.
What could go wrong: This is an observational registry, not a controlled trial, so results may be less definitive. Risks include device-related complications like stroke, embolization, or residual shunts.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

atrial septal defect

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ATRIAL SEPTAL DEFECT

Contacts and locations

Locations

HCOR - Associação Beneficente Síria
RECRUITING

São Paulo, Brazil
Hospital Beneficência Portuguesa
RECRUITING

São Paulo, Brazil
Hospital Pequeno Príncipe
RECRUITING

Curitiba, Brazil
Onassis Cardiac Surgery Center
RECRUITING

Kallithea, Greece
Santa Casa de Misericórdia de Porto Alegre
RECRUITING

Porto Alegre, Brazil

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