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Next-Gen heart defibrillators put to the test

NCT ID NCT07360158

Disease control Sponsor: Biotronik SE & Co. KG 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study will test the safety and performance of a new generation of implantable heart devices called CorSky ICDs and CRT-Ds. These devices help control dangerous heart rhythms in people with heart failure or tachyarrhythmia. About 151 participants will be implanted with the device and monitored for 6 months using home monitoring technology.

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 confirm that the new CorSky devices are safe and work well for controlling dangerous heart rhythms.
What could go wrong
This is a post-market study, not a large randomized trial. It only follows 151 people for 6 months, so long-term benefits or rare risks may not be fully captured.

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

About 151 people

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

Started

Jun 2026

Expected to finish

May 2028

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.

Who is studied

Standard indication for ICD or CRT-D

Ages

18 to 99 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.

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 * Ability to understand the nature of the study. * 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 an interventional clinical investigation in parallel to this study. , * Life-expectancy less than 12 months.

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Conditions

The condition(s) this trial relates to.

cardiac rhythm disease heart failure Tachycardia

As listed by the trial registrant

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

Heart failure Tachyarrhythmia Tachycardia, heart failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites in 4 countries. 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

  • Fakultní nemocnice u sv. Anny v Brně

    RECRUITING

    Brno, CZ-65691, Czechia

  • Medizinische Universität Graz

    RECRUITING

    Graz, Styria, 8010, Austria

  • Nemocnice Ceske Budejovice, a.s.

    RECRUITING

    České Budějovice, 37001, Czechia

  • SRH Wald-Klinikum Gera GmbH

    RECRUITING

    Gera, Thuringia, 07548, Germany

  • Semmelweis University

    RECRUITING

    Budapest, 1122, Hungary

  • University of Pécs

    RECRUITING

    Pécs, H-7624, Hungary

  • Universitätsklinikum Würzburg

    RECRUITING

    Würzburg, Bavaria, 97080, Germany

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