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CSP-SOLIA-REGISTRY
Sponsor: Hospital SOS Cardio
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.
Official title: Brazilian Assessment of Technique, Utilization, QRS Response, and Long-term Electrical Performance of the Solia CSP Lead
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2026-11-02
Completion Date
2029-09-02
Last Updated
2026-09-09
Healthy Volunteers
Yes
Conditions
Interventions
Solia CSP S Lead
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.