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Can a new ultrasound catheter give doctors a better view inside the heart?

NCT ID NCT07806890

Knowledge-focused Sponsor: The Cleveland Clinic 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

Researchers at the Cleveland Clinic are testing a prototype 4D intracardiac echocardiography (ICE) catheter that provides real-time ultrasound images from inside the heart. The study involves 20 adults scheduled for a left atrial appendage closure procedure, a common treatment for atrial fibrillation. The catheter is used alongside standard imaging to see if it offers clearer pictures and better guidance during the procedure. The goal is to compare its image quality and safety with current methods, not to change the treatment itself.

What this could mean

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

Active substance
4D ICE catheter used as an adjunct imaging tool during heart procedures
What this could lead to
If it works, this could improve how doctors see the heart during procedures, potentially making them safer and more precise.
What could go wrong
This is a small early study focused on imaging quality, not on changing treatment outcomes. The catheter is used only as an extra tool, so any benefit may be modest.

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 20 people

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

Started

Aug 2026

Expected to finish

Dec 2028

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. Be aged above 18 for adult participants 2. Be scheduled for a LAAO transcatheter procedure with or without concurrent procedures. 3. Be able and willing to give informed consent 4. (For concomitant cases only) Ablation will occur prior to LAAO implantation Exclusion Criteria: Potential subjects must not include: 1. Subjects who are currently enrolled in any other investigational clinical studies 2. Subjects with any bleeding diathesis 3. Subjects with known vascular abnormality rendering right heart catheterization from right or left femoral vein impossible. 4. Subjects with known intracardiac thrombus 5. Subjects with myocardial infarction within the prior two months 6. Subjects with class IV angina or heart failure 7. Subjects with sepsis or active infection 8. Subjects with immune-deficiency or immune-compromised status 9. Subjects with cerebral ischemic event in the prior six months 10. Subjects with deep vein thrombosis

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

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

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

  • Cleveland Clinical Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

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