BIO|STREAM.CSP Study

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

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

Trial locations and contacts

46 sites in 13 countries. Contact the study team or a site near you to ask about taking part.

About this study

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

Conditions

Cardiac Pacing, Cardiac Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy Devices, Bradycardia, Tachycardia

Being tested

Implantation of the Solia CSP S pacing lead for LBBAP

Keywords

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

Medical subject headings

Bradycardia, Tachycardia, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Implantation of the Solia CSP S pacing lead for LBBAPDevice

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

What is being measured

The primary outcome is the main question the study is designed to answer.

1. SADE-d free rate related to any investigatonal device

   Rate of serious adverse device effects possible, probable or causal related to any investigational device.

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

2. 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.

   Measured: Day 1

3. 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.

   Measured: Day 1

4. 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.

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

5. 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.

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

6. Electrical parameters - sensing amplitude

   The investigators will be asked to record the sensing amplitude (Millivolts) of the LBBAP leads.

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

7. Electrical parameters - pacing impedance

   The investigators will be asked to record the lead pacing impedance (Ohms) of the LBBAP leads.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted6 Feb 2026
2. Study start25 May 2026
3. Primary completion1 Feb 2033 (estimated)
4. Study completion1 Feb 2033 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Cardiac PacingStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.