BIO|STREAM.CSP Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBiotronik SE & Co. KG

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Implantation of the Solia CSP S pacing lead for LBBAP

Treatment groups

No treatment groups listed

Sponsors and collaborators