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3D-Printed heart models could make stroke prevention safer

NCT ID NCT07483008

Disease control Sponsor: Chinese University of Hong Kong Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether using a 3D-printed model of a heart chamber helps doctors better plan a procedure to close off a small pouch in the heart. This pouch, called the left atrial appendage, is a common source of blood clots that can cause stroke in people with atrial fibrillation. The trial involved 184 people and compared standard planning with planning that included a custom 3D-printed model. The goal was to see if the 3D model leads to a more complete seal and fewer complications.

What this could mean

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

Active substance
3D-printed models of the left atrial appendage
What this could lead to
If it works, this could make a common heart procedure safer and more effective, reducing complications like stroke and bleeding.
What could go wrong
This is a single, completed trial with 184 people. The technology may not improve outcomes enough to justify the extra cost and time.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

184 people

The number who actually took part.

Started

Oct 2017

Finished

Jan 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

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: * Age ≥18 years * Non-valvular atrial fibrillation * CHA2DS2-VASc ≥2 * Absolute or relative contraindications to long-term oral anticoagulation (e.g. history of intracranial or life-threatening bleeding, HAS-BLED ≥3, triple anticoagulant therapy) * Planned for LAAO procedure Exclusion Criteria: * Intracardiac thrombus is visualized by echocardiographic imaging * An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present * The LAA anatomy will not accommodate a device * Any of the customary contraindications for other percutaneous catheterization procedures (e.g., patient size too small to accommodate TEE probe or required catheters) or conditions (e.g., active infection, bleeding disorder) are present. * Known hypersensitivity to any portion of the device material or the individual components * Comorbidities other than atrial fibrillation that required oral anticoagulation * Suboptimal LAA image on TEE or CT that is inadequate for 3D modelling and printing * Refusal to participate the study

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Conditions

The condition(s) this trial relates to.

atrial fibrillation stroke disorder prevention target

As listed by the trial registrant

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

3D printing Atrial fibrillation (AF) Cost-benefit analysis

Contacts and locations

Locations

  • Division of Cardiology, Department of Medicine and Therapeutics Faculty of Medicine, The Chinese University of Hong Kong

    Hong Kong, New Territories, Sha Tin, Hong Kong

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