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New heart device tested in everyday use to seal birth defects

NCT ID NCT05887700

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 145 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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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