| NCT ID | NCT07393009 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Biotronik SE & Co. KG |
| Condition | Cardiac Pacing |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2026-05-25 |
| Primary Completion | 2033-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2026-05-25 with a primary completion date of 2033-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07393009 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Pacing. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07393009 currently recruiting?
Yes, NCT07393009 is actively recruiting participants. Contact the research team at csp-stream@biotronik.com for enrollment information.
Where is the NCT07393009 trial being conducted?
This trial is being conducted at Adelaide, Australia, Linz, Austria, Olomouc, Czechia, Prague, Czechia and 11 additional locations.
Who is sponsoring the NCT07393009 clinical trial?
NCT07393009 is sponsored by Biotronik SE & Co. KG. The trial plans to enroll 1,000 participants.