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New pacemaker system aims to improve heart rhythm therapy

NCT ID NCT06620237

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests the safety and performance of a new pacemaker system (Amvia pacemaker and Solia CSP S lead) for people who need help with their heart's electrical system. The device is designed to pace a specific part of the heart's natural wiring to improve efficiency. 152 participants will be followed for at least a year to monitor for any serious side effects.

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 152 people

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

Started

Oct 2024

Expected to finish

Sep 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: For patient enrollment in the study all of the following inclusion criteria have to be fulfilled at the time of enrollment: * Standard indication for de novo pacemaker implantation or cardiac resynchronization therapy (CRT) * Patient is intended for implantation of a pacemaker or CRT-P system with left bundle branch area stimulation * Ability to understand the nature of the study * Ability and willingness to perform all follow-up visits at the study site * Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring concept Exclusion Criteria: Enrollment of a patient is not permitted if at least one of the following criteria is fulfilled: * Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months * Expected to receive heart transplantation or ventricular assist device within 12 months * Life-expectancy less than 12 months * Pregnant or breast feeding * Age less than 18 years * Participation in another interventional clinical investigation (according to the definition given in the CIP)

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac Bradycardia cardiac conduction defect Cardiac Conduction System Disease heart conduction disease heart failure

As listed by the trial registrant

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

Bradycardia Cardiac pacemaker, artificial Cardiac pacing, artificial Cardiac resynchronization therapy devices Conduction defect, cardiac Conduction disorder Heart failure

Contacts and locations

Locations

  • AZ Sint-Jan

    Bruges, 8000, Belgium

  • Auckland City Hospital

    Grafton, 1023, New Zealand

  • Catharina Ziekenhuis

    Eindhoven, 5623 EJ, Netherlands

  • Centre Hospitalier Metz-Thionville

    Metz, 57038, France

  • Clinique Saint-Pierre Ottignies

    Ottignies, 1340, Belgium

  • Grand Hôpital de Charleroi

    Charleroi, 6060, Belgium

  • Hopital de la Timone (CHU La Timone)

    Marseille, 13005, France

  • Hôpital Haut Lévêque (CHU)

    Pessac, 33600, France

  • Hôpital privé du Confluent

    Nantes, 44277, France

  • Integral Healthcare

    Adelaide, 5068, Australia

  • Lyell McEwin Hospital

    Elizabeth Vale, 5112, Australia

  • Noordwest Ziekenhuisgroep

    Alkmaar, 1815 JD, Netherlands

  • UZ Gent - Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • Victorian Heart Hospital

    Clayton, 3168, Australia

More trials for these conditions

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