RecruitingNot Applicable

BIO|STREAM.CSP Study

Australia, Austria, Czechia1,000 participantsStarted 2026-05-25

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

SADE-d free rate related to any investigatonal device

Timeframe: throughout study duration, average of 4 years; annual evaluations

Rate of successful acute implantation in LBBAP using investigational devices in LBBAP

Timeframe: Day 1

Capture type at implantation

Timeframe: Day 1

Long-term maintenance of LBBAP

Timeframe: throughout study duration, average of 4 years; annual evaluations

Electrical parameters - pacing threshold

Timeframe: throughout study duration, average of 4 years; annual evaluations

Electrical parameters - sensing amplitude

Timeframe: throughout study duration, average of 4 years; annual evaluations

Electrical parameters - pacing impedance

Timeframe: throughout study duration, average of 4 years; annual evaluations

Trial details

NCT IDNCT07393009

SponsorBiotronik SE & Co. KG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2033-02-01

Contact for this trial

Johannes Pfaffenberger

+493068905 csp-stream@biotronik.com

View on ClinicalTrials.gov More Cardiac Pacing trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

SADE-d free rate related to any investigatonal device

Timeframe: throughout study duration, average of 4 years; annual evaluations

Rate of successful acute implantation in LBBAP using investigational devices in LBBAP

Timeframe: Day 1

Capture type at implantation

Timeframe: Day 1

Long-term maintenance of LBBAP

Timeframe: throughout study duration, average of 4 years; annual evaluations

Electrical parameters - pacing threshold

Timeframe: throughout study duration, average of 4 years; annual evaluations

Electrical parameters - sensing amplitude

Timeframe: throughout study duration, average of 4 years; annual evaluations

Electrical parameters - pacing impedance

Timeframe: throughout study duration, average of 4 years; annual evaluations