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New pacemaker setting aims to cut irregular heartbeat risk

NCT ID NCT07608822

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 17, 2026 · Updated 1 time

Summary

This study is observing 150 people who have a pacemaker with a special setting called Closed Loop Stimulation (CLS) combined with left bundle branch area pacing. The goal is to see if this setting reduces the occurrence of atrial fibrillation over two years. Participants have sinus node disease or heart block and are already enrolled in a larger registry. The study will track device-detected atrial fibrillation episodes and heart rate patterns.

What this could mean

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

Active substance
Left bundle branch area pacing with Closed Loop Stimulation (pacemaker device)
What this could lead to
If successful, this could show that a specific pacemaker setting reduces the risk of atrial fibrillation in people with certain heart rhythm problems.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may not apply to all patients, and the device may not reduce atrial fibrillation as hoped.

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 150 people

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

Started

May 2026

Expected to finish

May 2030

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

Patients with an indication for de novo dual-chamber pacing due to SND with evidence of AV conduction disorders, enrolled in the BIO\|STREAM.CSP registry.

Ages

18 to 18 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: * Enrolled in the BIO\|STREAM.CSP registry * Standard indication for dual-chamber pacing due to any form of sinus node disease according to guidelines * DDD-CLS pacing mode activated * Either ≥ II degree AV block, or native PR interval ≥ 200 ms at baseline ECG with expected RVP ≥ 20% Exclusion Criteria: * Implantation dates back more than 90 days * History of clinical AF * Patients intended to receive, or already received a pacing lead for traditional RV pacing, His bundle pacing or right bundle branch pacing * Upgrade from previous pacemaker system * Patients transitioning from the BIO\|MASTER.CSP study * DDAF episodes present in the device memory at the time of registration

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Conditions

The condition(s) this trial relates to.

atrioventricular block sick sinus syndrome sinoatrial node disorder

As listed by the trial registrant

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

Atrioventricular block Sinus node disease

How to take part

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

  1. The places running it

    12 sites in 5 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

  • A.O.U. Maggiore della Carita di Novara

    RECRUITING

    Novara, Italy

  • Fondazione Policlinico Universitario "Agostino Gemelli" Università Cattolica del Sacro Cuore

    NOT_YET_RECRUITING

    Roma, Italy

  • Hospital Universitario 12 de Octubre

    NOT_YET_RECRUITING

    Madrid, Spain

  • Hospital Universitario La Fe

    NOT_YET_RECRUITING

    Valencia, Spain

  • Masarykova nemocnice v Usti nad Labem

    NOT_YET_RECRUITING

    Ústí nad Labem, Czechia

  • Niguarda hospital

    NOT_YET_RECRUITING

    Milan, Italy

  • Ospedale Di Summa - Perrino

    NOT_YET_RECRUITING

    Brindisi, Italy

  • Ospedale di Piove di Sacco

    NOT_YET_RECRUITING

    Piove di Sacco, Italy

  • SS Annunziata Taranto

    NOT_YET_RECRUITING

    Taranto, Italy

  • Semmelweis University

    NOT_YET_RECRUITING

    Budapest, Hungary

  • Unidade local de Saúde de Coimbra, EPE - Centro Hospitalar Universitario de Coimbra

    NOT_YET_RECRUITING

    Coimbra, Portugal

  • University of Szeged

    NOT_YET_RECRUITING

    Szeged, Hungary

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