Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New heart device tested in humans for first time

NCT ID NCT06840509

Disease control Sponsor: Biotronik Australia Pty Ltd. 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This early study tests the safety and performance of a new implantable defibrillator (the CorSky ICD) in 52 people who need one for heart failure or dangerous fast heart rhythms. Participants will be followed for 12 months to check for device-related problems. The device is programmed to each person's medical needs.

What this could mean

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

Active substance
CorSky ICD or CRT-D device
What this could lead to
If successful, this could lead to a new, safe option for implantable defibrillators that help control dangerous heart rhythms in people with heart failure.
What could go wrong
This is a very early, small study (52 people) focused only on safety and device function. It does not test whether the device improves health outcomes, and device-related complications are possible.

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

52 people

The number who actually took part.

Started

Jul 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

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 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: * Standard indication for ICD or CRT-D therapy according to clinical guidelines * Planned for de novo implantation of an ICD/CRT-D, or upgrade/exchange from existing ICD/CRT-D or pacemaker implant * Ability to understand the nature of the study * Willingness to provide written informed consent * Ability and willingness to perform all on-site follow-up visits at the study site Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring concept Exclusion Criteria: * For VR-T DX and CRT-DX: Permanent atrial tachyarrhythmia * For VR-T DX and CRT-DX: Patients requiring atrial pacing * Planned for His-Bundle-Pacing * Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months * Pregnant or breast feeding * Age less than 18 years * Participation in another interventional clinical investigation according to the definition given below 2,3 * Life-expectancy less than 12 months

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Heart failure are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

heart failure Tachycardia

As listed by the trial registrant

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

Heart failure Tachycardia

Contacts and locations

Locations

  • Princess Alexandra Hospital

    Brisbane, Australia

More trials for these conditions

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