Left Bundle Branch Area PacingNCT07808554
CSP-SOLIA-REGISTRY
An observational study of Left Bundle Branch Area Pacing, run by Hospital SOS Cardio.
Trial summary
The CSP Registry is a prospective, multicenter, observational, real-world study designed to evaluate the acute feasibility and long-term performance of the Solia CSP lead in Brazilian patients with a clinical indication for permanent ventricular pacing. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Left Bundle Branch Area Pacing
- What is being tested?
- Solia CSP S Lead
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2026to 2 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adult patients with a clinical indication for permanent ventricular pacing in whom the treating physician, based on routine clinical practice and independently of study participation, has decided to attempt conduction system pacing using the Solia CSP lead, preferably in the left bundle branch area. Participants will be consecutively enrolled at up to 10 electrophysiology centers in Brazil and followed for up to 24 months.
Who may be able to join
- Age ≥18 years. Clinical indication for a cardiac implantable electronic device requiring permanent ventricular pacing, according to contemporary guidelines.
- Treating physician's clinical decision to use the Solia CSP lead for conduction system pacing, preferably LBBAP.
- Planned implantation of a BIOTRONIK device with remote monitoring capability. Ability to comply with the study follow-up schedule for up to 24 months. Written informed consent.
Who cannot join
- Inability to provide written informed consent. Active systemic infection or local infection at the implantation site. Life expectancy <24 months due to a non-cardiovascular condition. Inability to comply with remote monitoring requirements. Participation in another cardiovascular device study with conflicting objectives or endpoints.
- Previous implantation of a CSP lead at the same anatomical site. Emergency procedure preventing standardized collection of baseline variables. Pregnancy or breastfeeding in women of childbearing potential.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Brazilian Assessment of Technique, Utilization, QRS Response, and Long-term Electrical Performance of the Solia CSP Lead
The CSP Registry is a prospective, multicenter, observational, real-world study designed to evaluate the acute feasibility and long-term performance of the Solia CSP lead in Brazilian patients with a clinical indication for permanent ventricular pacing. Approximately 300 adult participants will be enrolled at up to 10 electrophysiology centers in Brazil and followed for up to 24 months. The study will assess implantation success, electrical performance, maintenance of conduction system capture, procedure- and device-related complications, and relevant clinical outcomes.
Read the detailed description
The CSP Registry is a prospective, multicenter, observational, investigator-initiated study conducted at up to 10 electrophysiology centers in Brazil. The study plans to enroll approximately 300 adult patients with a clinical indication for permanent ventricular pacing in whom the treating physician has independently decided to use the Solia CSP lead (BIOTRONIK) for conduction system pacing (CSP), preferably left bundle branch area pacing (LBBAP).
The decision to implant the device, the selection of the lead and generator, the implantation technique, and device programming are based exclusively on routine clinical practice and are made independently of study participation. The Solia CSP lead is used within its approved indication and conditions of use. No experimental intervention or randomization is introduced by the protocol.
The primary objective is to evaluate the acute feasibility and longitudinal performance of the Solia CSP lead in real-world clinical practice. The primary endpoint is lead success at 12 months, based on a composite technical and electrophysiological outcome including successful implantation with confirmed CSP/LBBAP capture, acceptable electrical parameters, absence of clinically relevant loss of capture, absence of lead revision, dislodgement or abandonment, and absence of major lead-, procedure-, or device-related complications.
Secondary outcomes include acute implantation success, reasons for unsuccessful CSP/LBBAP capture or positioning, procedural characteristics, longitudinal pacing threshold, R-wave sensing and lead impedance, capture classification, heart failure hospitalization, all-cause mortality, changes in left ventricular ejection fraction when echocardiographic assessments are available, and findings from Home Monitoring. Exploratory analyses will evaluate clinical and procedural factors associated with implantation success and longitudinal lead performance.
Participants will be followed for up to 24 months after implantation, with predefined assessments including clinical evaluation, 12-lead electrocardiography, device interrogation, assessment of conduction system capture, electrical lead parameters, adverse events, and remote monitoring.
- Conditions
- Left Bundle Branch Area Pacing
- Being tested
- Solia CSP S Lead
- Keywords
- Conduction System Pacing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solia CSP S LeadDevice
The Solia CSP S lead (BIOTRONIK) is a stylet-driven, fixed-helix pacing lead used for conduction system pacing (CSP), preferably left bundle branch area pacing (LBBAP). The decision to use the lead is made by the treating physician according to clinical indication and routine practice, prior to and independently of study enrollment. The device is used within its approved indication and instructions for use. The study does not assign the intervention or modify the implantation procedure, but prospectively evaluates the lead's acute feasibility, electrical performance, safety, and clinical outcomes during follow-up.
What is being measured
The primary outcome is the main question the study is designed to answer.
Solia CSP Lead Success at 12 Months
Proportion of participants with Solia CSP lead success at 12 months, defined by the absence of lead revision, dislodgement or abandonment; unacceptable electrical parameters; serious lead-, procedure-, or device-related complications; and confirmed loss of CSP/LBBAP capture in participants with capture confirmed at implantation.
Measured: 12 months
Solia CSP Lead Success at 12 Months
Proportion of participants with Solia CSP lead success at 12 months, defined by the absence of lead revision, dislodgement or abandonment; unacceptable electrical parameters; serious lead-, procedure-, or device-related complications; and confirmed loss of CSP/LBBAP capture in participants with capture confirmed at implantation.
Measured: From implantation through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start2 Nov 2026 (estimated)
- Primary completion2 Mar 2028 (estimated)
- Study completion2 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Bundle Branch Area 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.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital SOS Cardio
- Sponsor type
- Research network
- Responsible party
- Principal investigator, André Davila, Hospital SOS Cardio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808554
- Sponsor's protocol ID
- CSP-SOLIA-REGISTRY
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brazilian Assessment of Technique, Utilization, QRS Response, and Long-term Electrical Performance of the Solia CSP Lead
- ClinicalTrials.gov ID
- NCT07808554
- Acronym / sponsor ID
- CSP-SOLIA-REGISTRY
- Conditions
- Left Bundle Branch Area Pacing
- Keywords
- Conduction System Pacing
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospital SOS CardioResearch network
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 2 Mar 2028 (estimated)
- Study completion
- 2 Sep 2029 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The CSP Registry is a prospective, multicenter, observational, real-world study designed to evaluate the acute feasibility and long-term performance of the Solia CSP lead in Brazilian patients with a clinical indication for permanent ventricular pacing. Approximately 300 adult participants will be enrolled at up to 10 electrophysiology centers in Brazil and followed for up to 24 months. The study will assess implantation success, electrical performance, maintenance of conduction system capture, procedure- and device-related complications, and relevant clinical outcomes.
Detailed description
The CSP Registry is a prospective, multicenter, observational, investigator-initiated study conducted at up to 10 electrophysiology centers in Brazil. The study plans to enroll approximately 300 adult patients with a clinical indication for permanent ventricular pacing in whom the treating physician has independently decided to use the Solia CSP lead (BIOTRONIK) for conduction system pacing (CSP), preferably left bundle branch area pacing (LBBAP).
The decision to implant the device, the selection of the lead and generator, the implantation technique, and device programming are based exclusively on routine clinical practice and are made independently of study participation. The Solia CSP lead is used within its approved indication and conditions of use. No experimental intervention or randomization is introduced by the protocol.
The primary objective is to evaluate the acute feasibility and longitudinal performance of the Solia CSP lead in real-world clinical practice. The primary endpoint is lead success at 12 months, based on a composite technical and electrophysiological outcome including successful implantation with confirmed CSP/LBBAP capture, acceptable electrical parameters, absence of clinically relevant loss of capture, absence of lead revision, dislodgement or abandonment, and absence of major lead-, procedure-, or device-related complications.
Secondary outcomes include acute implantation success, reasons for unsuccessful CSP/LBBAP capture or positioning, procedural characteristics, longitudinal pacing threshold, R-wave sensing and lead impedance, capture classification, heart failure hospitalization, all-cause mortality, changes in left ventricular ejection fraction when echocardiographic assessments are available, and findings from Home Monitoring. Exploratory analyses will evaluate clinical and procedural factors associated with implantation success and longitudinal lead performance.
Participants will be followed for up to 24 months after implantation, with predefined assessments including clinical evaluation, 12-lead electrocardiography, device interrogation, assessment of conduction system capture, electrical lead parameters, adverse events, and remote monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients with a clinical indication for permanent ventricular pacing in whom the treating physician, based on routine clinical practice and independently of study participation, has decided to attempt conduction system pacing using the Solia CSP lead, preferably in the left bundle branch area. Participants will be consecutively enrolled at up to 10 electrophysiology centers in Brazil and followed for up to 24 months.
Key inclusion criteria (3 listed)
- Age ≥18 years. Clinical indication for a cardiac implantable electronic device requiring permanent ventricular pacing, according to contemporary guidelines.
- Treating physician's clinical decision to use the Solia CSP lead for conduction system pacing, preferably LBBAP.
- Planned implantation of a BIOTRONIK device with remote monitoring capability. Ability to comply with the study follow-up schedule for up to 24 months. Written informed consent.
Key exclusion criteria (2 listed)
- Inability to provide written informed consent. Active systemic infection or local infection at the implantation site. Life expectancy <24 months due to a non-cardiovascular condition. Inability to comply with remote monitoring requirements. Participation in another cardiovascular device study with conflicting objectives or endpoints.
- Previous implantation of a CSP lead at the same anatomical site. Emergency procedure preventing standardized collection of baseline variables. Pregnancy or breastfeeding in women of childbearing potential.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solia CSP S LeadThe Solia CSP S lead (BIOTRONIK) is a stylet-driven, fixed-helix pacing lead used for conduction system pacing (CSP), preferably left bundle branch area pacing (LBBAP). The decision to use the lead is made by the treating physician according to clinical indication and routine practice, prior to and independently of study enrollment. The device is used within its approved indication and instructions for use. The study does not assign the intervention or modify the implantation procedure, but prospectively evaluates the lead's acute feasibility, electrical performance, safety, and clinical outcomes during follow-up. | Device | – |
Primary outcome
Solia CSP Lead Success at 12 Months
Time frame: 12 months
Proportion of participants with Solia CSP lead success at 12 months, defined by the absence of lead revision, dislodgement or abandonment; unacceptable electrical parameters; serious lead-, procedure-, or device-related complications; and confirmed loss of CSP/LBBAP capture in participants with capture confirmed at implantation.
Solia CSP Lead Success at 12 Months
Time frame: From implantation through 12 months
Proportion of participants with Solia CSP lead success at 12 months, defined by the absence of lead revision, dislodgement or abandonment; unacceptable electrical parameters; serious lead-, procedure-, or device-related complications; and confirmed loss of CSP/LBBAP capture in participants with capture confirmed at implantation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Bundle Branch Area Pacing, run by Hospital SOS Cardio.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact André B Davila (55 48 9 91234886, grazydamasceno@clinicaritmo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Solia CSP Lead Success at 12 Months (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.