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Heart device study aims to reduce painful shocks with smarter pacing

NCT ID NCT05426785

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two ways of programming implantable defibrillators (ICDs) in 398 Japanese patients. One group uses early, multiple bursts of rapid pacing (ATP) to stop dangerous heart rhythms, while the other uses a longer detection time before pacing. The goal is to see which approach reduces the need for painful shocks and is safe. Results could help doctors set ICDs to work better for patients.

What this could mean

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

Active substance
Anti-tachycardia pacing (ATP) delivered by an implantable cardioverter defibrillator (ICD)
What this could lead to
If successful, this could lead to fewer painful shocks from ICDs, improving quality of life for patients at risk of dangerous heart rhythms.
What could go wrong
This is a mid-stage study in a specific population (Japanese patients), so results may not apply broadly. The intervention is a device setting change, not a new therapy, so the impact is incremental.

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

About 398 people

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

Started

May 2023

Expected to finish

Dec 2027

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: * Patient has an indication for ICD according to the The Japanese Circulation Society (JCS )/ Japanese Heart Rhythm Society (JHRS) 2021 Guideline Focused Update on Non-Pharmacotherapy of Cardiac Arrhythmias * Patient is either planned for de novo ICD implantation or is already implanted with an investigational ICD for 10 days or less. * Patient can be treated with ATP therapy for both VT and VF zone * Patient is willing and able to use the CardioMessenger and accepts the Home Monitoring concept * Patient is willing to visit the hospital in accordance with physician's instruction * Patient is able to understand the nature of the study and to provide written informed consent Exclusion Criteria: * Patient planned for implantation with or already implanted with Cardiac Resynchronization Therapy Defibrillator (CRT-D) device * A patient who is confirmed to have received ICD therapy * A patient who is diagnosed as Idiopathic VF (e.g. Brugada syndrome, Long QT Syndrome, other IVF) * Age \< 18 years * A patient who has impaired mental status * Life expectancy less than 18 months * Participation in another interventional clinical investigation * Pregnant or breastfeeding

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Conditions

The condition(s) this trial relates to.

Shock ventricular fibrillation ventricular tachycardia

As listed by the trial registrant

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

Implantable cardioverter defibrillator (ICD)

Contacts and locations

Locations

  • Kokura Memorial Hospital

    Kitakyushu, Fukuoka, ８０２８５５５, Japan

More trials for these conditions

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