New heart imaging device tested in small study
NCT ID NCT05931835
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
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18 people
The number who actually took part.
- Started
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Jan 2025
- Finished
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May 2025
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Mater Private Network
Dublin, Leinster, D07 RD8P, Ireland
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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