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Which scan better guides a heart device implant?

NCT ID NCT07815119

Disease control Sponsor: Shanghai Zhongshan Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers compare two imaging strategies for planning left atrial appendage closure in adults with nonvalvular atrial fibrillation. Participants are randomly assigned to have their heart anatomy assessed either by transesophageal echocardiography or by cardiac CT angiography before the procedure. The trial tracks serious safety events during and shortly after the procedure, and later checks for leaks or other device-related issues. The goal is to see whether one imaging approach leads to better outcomes.

What this could mean

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

Active substance
Preprocedural imaging strategy: transesophageal echocardiography or cardiac CT angiography
What this could lead to
If one imaging method proves safer or more accurate, doctors could adopt it as the standard way to plan left atrial appendage closure, potentially lowering procedure complications.
What could go wrong
The trial may find little difference between the two imaging strategies, or the results may not apply to all hospitals or patients. Both imaging tests carry small risks, such as discomfort or contrast reactions.

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

About 590 people

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

Started

Sep 2026

Expected to finish

Sep 2029

An estimate. End dates often move.

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: * 1\. Age 18 years or older. 2. Diagnosis of nonvalvular atrial fibrillation, including paroxysmal, persistent, or permanent atrial fibrillation. 3\. Planned percutaneous left atrial appendage closure for stroke prevention and considered by the investigator to meet an accepted indication for LAAC. 4\. Able to complete randomization and the assigned preprocedural imaging assessment. 5\. Expected to be able to complete paired TEE and CCTA follow-up at 3 months after LAAC. 6\. Able to complete protocol-specified clinical follow-up. 7. Written informed consent provided by the participant. Exclusion Criteria: * 1\. Atrial fibrillation with moderate or severe mitral stenosis or a history of mechanical valve replacement. 2\. Contraindication to TEE, such as severe esophageal disease or inability to tolerate the procedure. 3\. Contraindication to CCTA, such as severe renal dysfunction or a known allergy to iodinated contrast that cannot be adequately premedicated. 4\. Another established indication for long-term full-dose anticoagulation, such as a mechanical valve or active venous thromboembolism. 5\. Life expectancy shorter than 1 year or a severe noncardiovascular disease that may prevent completion of follow-up or reliable assessment of clinical events. 6\. Pregnancy or breastfeeding. 7. Any other condition that, in the investigator's judgment, makes participation inappropriate.

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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.

Nonvalvular atrial fibrillation

How to take part

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

  1. The places running it

    1 site. 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

  • Zhognshan Hospital ,Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

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