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Can mixed reality make heart valve surgery safer and faster?

NCT ID NCT06539416

Disease control Sponsor: Nemocnice AGEL Trinec-Podlesi a.s. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This trial tests whether doctors using mixed reality goggles (HoloLens 2.0) can perform MitraClip heart valve repair more efficiently and with less stress. Twenty adults with leaky mitral valves will undergo the standard clip procedure, but the surgeon will also wear a headset that projects 3D images of the heart. Researchers will measure procedure time, radiation exposure, and the surgeon's stress levels to see if the technology helps.

What this could mean

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

Active substance
MitraClip implantation (a procedure to repair a leaky heart valve) guided by mixed reality using HoloLens 2.0
What this could lead to
If successful, mixed reality could make MitraClip procedures faster, safer, and less stressful for doctors.
What could go wrong
This is a very small early study with only 20 participants, so results may not apply broadly. The technology may not improve outcomes or could add complexity.

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.

Participants

20 people

The number who actually took part.

Started

Aug 2024

Finished

Sep 2025

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.

Who is studied

The study population comprises adult patients aged over 18 who require MitraClip implantation for the treatment of mitral valve regurgitation. These patients are selected from the patient pool at Hospital AGEL Trinec-Podlesi, Trinec, Czechia.

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: * Adults aged over 18 years * Patients diagnosed with mitral valve regurgitation requiring MitraClip implantation * Ability to provide informed consent and comply with study procedures Exclusion Criteria: * Patients with contraindications for MR technology (e.g., MRI incompatibility) * Individuals unable to comply with study procedures due to physical or cognitive impairments * Pregnant or breastfeeding women

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Conditions

The condition(s) this trial relates to.

mitral valve insufficiency

As listed by the trial registrant

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

Mitral regurgitation

Contacts and locations

Locations

  • Hospital AGEL Trinec-Podlesi a.s.

    Třinec, CZ, 73961, Czechia

More trials for these conditions

Other studies related to the condition(s) this trial covers.