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New study tracks Real-World use of advanced heart pacemakers

NCT ID NCT07393009

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 30, 2026 · Updated 3 times

Summary

This study will observe 1000 people who receive BIOTRONIK pacemakers for conditions like slow heartbeat or heart failure. The goal is to see how well the devices work in everyday medical practice, focusing on safety and performance over time. Researchers will track device-related side effects and how effectively the leads pace the heart.

What this could mean

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

Active substance
BIOTRONIK pacemaker devices (Solia CSP S pacing lead)
What this could lead to
If successful, this could confirm that these devices work well in everyday care, potentially improving pacing methods for 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 device risks like infection or lead issues remain.

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 1,000 people

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

Started

May 2026

Expected to finish

Feb 2033

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

The patient population consists exclusively of patients with an indication for pacemaker or cardiac resynchronization therapy according to the current clinical practice.

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: * Guideline indication for pacemaker or cardiac resynchronization therapy with or without defibrillation function (CRT-P/-D) * Patient is intended for a de novo implantation and LBBAP therapy with an investigational generator and an investigational lead OR has just been implanted with an investigational generator and an investigational lead positioned permanently deep within the intraventricular septum and has not yet been discharged from the hospital OR transitions from the BIO\|MASTER.CSP study * Ability to understand the nature of the study * Ability and willingness to perform all follow-up visits * Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring concept Exclusion Criteria: * Planned dation from intended use * Planned for cardiac surgical procedures, heart transplantation or interventional measures other than the study procedure within one year after enrollment * Life-expectancy less than 12 months * Pregnant or breast feeding * Age less than 18 years * Participation in an interventional clinical investigation, except for submodules within this study.

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Conditions

The condition(s) this trial relates to.

Bradycardia heart failure Tachycardia

As listed by the trial registrant

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

Bradycardia Cardiac pacemaker Cardiac pacing Cardiac resynchronization therapy devices Heart failure Implantable cardioverter defibrillator Tachycardia

How to take part

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

  1. The places running it

    40 sites in 13 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

  • Assuta Medical Center

    NOT_YET_RECRUITING

    Ashdod, Israel

  • Auckland City Hospital

    NOT_YET_RECRUITING

    Grafton, New Zealand

  • Central Hospital of Northern Pest - Military Hospital

    RECRUITING

    Budapest, Hungary

  • Centre Hospitalier Metz-Thionville

    NOT_YET_RECRUITING

    Metz, France

  • FN Kralovske Vinohrady

    NOT_YET_RECRUITING

    Prague, Czechia

  • Fakultní nemocnice Olomouc

    NOT_YET_RECRUITING

    Olomouc, Czechia

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

    NOT_YET_RECRUITING

    Roma, Italy

  • Herz- und Diabeteszentrum NRW

    NOT_YET_RECRUITING

    Bad Oeynhausen, Germany

  • Hillel Yaffe Medical Center

    NOT_YET_RECRUITING

    Hadera, Israel

  • Hospital La Luz

    NOT_YET_RECRUITING

    Madrid, Spain

  • Hospital Universitari Germans Trias i Pujol

    NOT_YET_RECRUITING

    Barcelona, Spain

  • Hospital Universitario 12 de Octubre

    NOT_YET_RECRUITING

    Valencia, Spain

  • Hospital Universitario La Fe

    NOT_YET_RECRUITING

    Valencia, Spain

  • Hôpital Gabriel Montpied

    NOT_YET_RECRUITING

    Clermont-Ferrand, France

  • Hôpital Haut Lévêque

    NOT_YET_RECRUITING

    Pessac, France

  • Hôpital de la Timone

    NOT_YET_RECRUITING

    Marseille, France

  • Hôpital privé du Confluent

    NOT_YET_RECRUITING

    Nantes, France

  • Inselspital, Universitätsspital Bern

    NOT_YET_RECRUITING

    Bern, Switzerland

  • Integral Healthcare

    NOT_YET_RECRUITING

    Adelaide, Australia

  • Kepler Universitätsklinikum GmbH

    NOT_YET_RECRUITING

    Linz, Austria

  • Kerckhoff-Klinik GmbH

    NOT_YET_RECRUITING

    Bad Nauheim, Germany

  • Krankenhaus Porz am Rhein gGmbH

    NOT_YET_RECRUITING

    Cologne, Germany

  • Niels-Stensen-Kliniken, Marienhospital Osnabrück

    NOT_YET_RECRUITING

    Osnabrück, Germany

  • 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

  • Pauls Stradins Clinical University Hospital

    NOT_YET_RECRUITING

    Riga, Latvia

  • SS Annunziata Taranto

    NOT_YET_RECRUITING

    Taranto, Italy

  • Semmelweis University

    NOT_YET_RECRUITING

    Budapest, Hungary

  • Shaare Zedek MC

    NOT_YET_RECRUITING

    Jerusalem, Israel

  • Soroka Medical Center

    NOT_YET_RECRUITING

    Beersheba, Israel

  • Tel Aviv Sourasky Medical Center

    NOT_YET_RECRUITING

    Tel Aviv, Israel

  • Unidade Local de Saúde de Santa Maria, E. P. E.

    NOT_YET_RECRUITING

    Lisbon, Portugal

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

    NOT_YET_RECRUITING

    Coimbra, Portugal

  • Unidade local de Saúde de Sao José, EPE - Hospital Santa Marta

    NOT_YET_RECRUITING

    Lisbon, Portugal

  • University of Pécs

    RECRUITING

    Pécs, Hungary

  • University of Szeged

    NOT_YET_RECRUITING

    Szeged, Hungary

  • Universitäts-Herzzentrum Freiburg Bad Krozingen

    NOT_YET_RECRUITING

    Bad Krozingen, Germany

  • Universitätsspital Zürich (USZ)

    NOT_YET_RECRUITING

    Zurich, Switzerland

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