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Taking people in FranceNo phase

Follow-up of People With Heart Devices Using Conduction System Pacing

Follows adults whose heart pacing devices use a Solia lead in routine care.

Key facts

Who runs it
Biotronik SE & Co. KG
Where
Clermont-Ferrand, Marseille, Metz, Nantes, Pessac, and Saint-Laurent-du-Var, FranceSee the 6 sitesAlso in 12 other countries, 40 sites
Trial code
Registry title
BIO|STREAM.CSP Study
Status
Recruiting
People taking part
1,000 people, planned
Started
25 May 2026
Expected to end
1 Feb 2033
Type of study
Observational
Treatments tested
  • Implantation of the Solia CSP S pacing lead for LBBAP
Record updated
23 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who need a pacemaker or a cardiac resynchronization device and are getting, or have just received, a BIOTRONIK device placed deep in the heart's septum (conduction system pacing).

Age
18 years and older
Sex
All
Disease stage
A guideline-based need for a pacemaker or cardiac resynchronization therapy, with or without a defibrillator function.
Earlier treatment
New first-time implant of the study generator and lead, or just implanted and not yet sent home, or coming over from the BIO|MASTER.CSP study.

Main reasons for not taking part

  • Life expectancy under 12 months
  • Pregnant or breastfeeding
  • Under 18 years old
  • Planned heart surgery, heart transplant or other heart procedures within one year after joining
  • Taking part in another interventional trial, except sub-parts of this study

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Planned for cardiac surgical procedures, heart transplantation or interventional measures other than the study procedure within one year after enrollment
  • Age less than 18 years
  • Planned dation from intended use
  • Life-expectancy less than 12 months
  • Pregnant or breast feeding
  • Participation in an interventional clinical investigation, except for submodules within this study

Where in France

Also in 12 other countries, 40 sites

  • Hopital Gabriel MontpiedClermont-Ferrand, FranceContact: Johannes PfaffenbergerTaking people
  • Hopital de la TimoneMarseille, FranceContact: Johannes PfaffenbergerNot yet recruiting
  • Centre Hospitalier Metz-ThionvilleMetz, FranceContact: Johannes PfaffenbergerNot yet recruiting
  • Hôpital Privé du ConfluentNantes, FranceContact: Johannes PfaffenbergerTaking people
  • Hopital Haut-LevequePessac, FranceContact: Johannes PfaffenbergerNot yet recruiting
  • Institut Arnaud TzanckSaint-Laurent-du-Var, FranceContact: Johannes PfaffenbergerNot yet recruiting

About the trial

What the trial wants to find out

The registry is designed to assess outcome, performance and residual safety aspects of BIOTRONIK products which are used in the context of CSP based on long-term data from an unselected, real-life clinical set-up.

Treatments tested

  • Implantation of the Solia CSP S pacing lead for LBBAP

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Observation of Clinical Routine Care for Patients Implanted With BIOTRONIK Devices Used for Conduction System Pacing (CSP)
Plain-language title
Follow-up of People With Heart Devices Using Conduction System PacingGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
23 October 2026