CSP-SOLIA-REGISTRY

NCT07808554 | Not Yet Recruiting

• 1 other identifier: CSP-SOLIA-REGISTRY
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Left Bundle Branch Area Pacing

Keywords

Conduction System Pacing

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From implantation through 12 months

Interventions

Solia CSP S Lead DEVICE

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital SOS Cardio: lead

Central Study Contacts

André B Davila

CONTACT

55 48 9 91234886; grazydamasceno@clinicaritmo.com.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: André Davila

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 9, 2026
• Study Start (Estimated): November 2, 2026
• Primary Completion (Estimated): March 2, 2028
• Study Completion (Estimated): September 2, 2029
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share