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Pacemaker that thinks for itself could ease heart failure

NCT ID NCT04774523

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested a pacemaker feature called AutoAdapt that automatically adjusts timing settings to help the heart pump better. It involved 198 people with heart failure who needed a special pacemaker. The goal was to see if this smart feature improves symptoms, reduces hospital stays, and boosts quality of life compared to standard settings.

What this could mean

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

Active substance
BIOTRONIK AutoAdapt algorithm (pacemaker feature)
What this could lead to
If successful, this could improve heart function and quality of life for people with heart failure who need a special pacemaker.
What could go wrong
This is a completed study, but results may not apply to all heart failure patients. The feature may not provide significant benefit over standard settings.

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

198 people

The number who actually took part.

Started

Aug 2021

Finished

Jul 2025

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: * Indication for de novo implantation or upgrade to a CRT-D device * Enrolled in BIO\|STREAM.HF but not yet implanted with or upgraded to CRT-D * LVEF \< 35% * QRS \> 120 ms * NYHA II-IV * Atrial heart rate during sinus rhythm at rest below 100 bpm * Patient is able to understand the nature of the study and willing to provide written informed consent to this submodule Exclusion Criteria: * Planned implantation or previous implantation with a BIOTRONIK DX ICD lead * History of persistent/permanent AF * History of complete AV-block

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac heart failure left ventricular failure ventricular arrhythmias due to cardiac ryanodine receptor calcium release deficiency syndrome Ventricular Dysfunction, Left

As listed by the trial registrant

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

Cardiac arrhythmia Heart failure Left ventricular dysfunction

Contacts and locations

Locations

  • Dr Francisco Javier Garcia

    Burgos, Castille and León, 09006, Spain

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