Studying Routine Patient Care With BIOTRONIK Devices That Allow a More Natural Heart Stimulation (BIO|STREAM-CSP)

Observation of Clinical Routine Care for Patients Implanted With BIOTRONIK Devices Used for Conduction System Pacing (CSP)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; Bradycardia; Tachycardia; Cardiac Pacing; Implantable Cardioverter Defibrillator; Cardiac Pacemaker; Cardiac Resynchronization Therapy Devices
• Intervention / Treatment: Device: Implantation of the Solia CSP S pacing lead for LBBAP

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Johannes Pfaffenberger; Phone Number: 1318 +493068905; Email: csp-stream@biotronik.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The patient population consists exclusively of patients with an indication for pacemaker or cardiac resynchronization therapy according to the current clinical practice.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SADE-d free rate related to any investigatonal device	Rate of serious adverse device effects possible, probable or causal related to any investigational device.	throughout study duration, average of 4 years; annual evaluations
Rate of successful acute implantation in LBBAP using investigational devices in LBBAP	All implantations, in which the investigator decides to leave the Solia CSP S pacing lead permanently deep within the intraventricular septum are counted as acute success.	Day 1
Capture type at implantation	The investigator confirms the type of pacing capture for any implantation in which the pacing lead is permanently positioned deep within the interventricular septum. Success rates for LBBAP and CSP are determined based on ECG parameters.	Day 1
Long-term maintenance of LBBAP	The investigator is asked to assess the effectiveness of LBBAP during follow-up based on the interpretation of a 12-lead ECG recording.	throughout study duration, average of 4 years; annual evaluations
Electrical parameters - pacing threshold	The investigators will be asked to record the pacing thresholds (Volts) of the LBBAP leads at a pulse width of 0.4 ms.	throughout study duration, average of 4 years; annual evaluations
Electrical parameters - sensing amplitude	The investigators will be asked to record the sensing amplitude (Millivolts) of the LBBAP leads.	throughout study duration, average of 4 years; annual evaluations
Electrical parameters - pacing impedance	The investigators will be asked to record the lead pacing impedance (Ohms) of the LBBAP leads.	throughout study duration, average of 4 years; annual evaluations

Collaborators and Investigators

• Sponsor: Biotronik SE & Co. KG

Study record dates

Study Major Dates

• Study Start (Estimated): May 29, 2026
• Primary Completion (Estimated): February 1, 2033
• Study Completion (Estimated): February 1, 2033

Study Registration Dates

• First Submitted: January 9, 2026
• First Submitted That Met QC Criteria: January 30, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Conduction system pacing (CSP); Left bundle branch area pacing (LBBAP)
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Heart Failure; Tachycardia; Bradycardia
• Other Study ID Numbers: BA118

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No