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New heart imaging device tested in small study

NCT ID NCT05931835

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new imaging system called VERAFEYE in 18 people already scheduled for standard heart procedures like ablation or closure. Doctors used the device during the procedure and gave feedback via a questionnaire. The goal was to gather information to improve the system, not to prove it works or is safe.

What this could mean

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

Active substance
VERAFEYE System (imaging device)
What this could lead to
If successful, this could help refine a new imaging tool to assist doctors during heart procedures.
What could go wrong
This is a very early feasibility study with only 18 people, not designed to prove safety or effectiveness. Results may not lead to a usable product.

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

18 people

The number who actually took part.

Started

Jan 2025

Finished

May 2025

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.

Ages

18 to 80 years

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.

Key Inclusion Criteria: * Subject is 18 to 80 years of age at the time of consent * Subject is scheduled to undergo a standard of care, de-novo catheter-ablation procedure to treat typical AFL or AF; or left atrial appendage (LAA)/ atrial septal defect (ASD) closure procedure * Subject is able to understand and willing to provide written informed consent Key Exclusion Criteria: * Any of the following within 6 months prior to enrolment: * Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotomy * Thromboembolic event (stroke), transient ischemic attack (TIA) or neurological disturbances * Myocardial infarction * Any surgical or percutaneous cardiac procedure including coronary intervention and cardiac ablation * Dilated or hypertropic cardiomyopathy * Any planned surgical or endovascular intervention within 30 days before or after the ablation, or LAA/ASD closure procedure. * Any of the following cardiac conditions: * New York Heart Association (NYHA) class IV * Left ventricular ejection fraction (LVEF) \< 30% * Implanted with a cardiac rhythm management device (pacemaker, CRT, ICD, loop recorder) * Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation * Active coronary ischemia, significant valvular heart disease, or hemodynamically significant congenital cardiac abnormality * Body mass index (BMI) \> 40 kg/m2 * Body weight \< 50kg * Pregnant women or women who plan to become pregnant during the course of their participation in the study (women should either be of non- childbearing potential at the time of enrolment (as documented in the medical file) or have a negative pregnancy test within the previous 7 days prior to the ablation, or LAA/ASD closure procedure) * Life expectancy less than 12 months * Subjects who are currently enrolled in another study * Subjects with a thrombus or pericardial effusion detected in the LA/LAA during standard of care imaging

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Mater Private Network

    Dublin, Leinster, D07 RD8P, Ireland

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