Studying Routine Patient Care With BIOTRONIK Devices That Allow a More Natural Heart Stimulation

NCT07393009 | Not Yet Recruiting

• 1 other identifier: BA118
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiac Pacing; Implantable Cardioverter Defibrillator; Cardiac Pacemaker; Bradycardia; Cardiac Resynchronization Therapy Devices; Tachycardia; Heart Failure

Keywords

Conduction system pacing (CSP); Left bundle branch area pacing (LBBAP)

Outcome Measures

Primary Outcomes (7)

• 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

Interventions

Implantation of the Solia CSP S pacing lead for LBBAP DEVICE

Observation of clinical routine care for patients implanted with BIOTRONIK devices used for conduction system pacing (CSP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

MeSH Terms

Conditions

Bradycardia; Tachycardia; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Conduction System Disease

Central Study Contacts

Johannes Pfaffenberger

CONTACT

+493068905; csp-stream@biotronik.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: February 6, 2026
• Study Start: May 29, 2026
• Primary Completion (Estimated): February 1, 2033
• Study Completion (Estimated): February 1, 2033
• Last Updated: May 15, 2026

Record last verified: 2025-12