About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame

12 months

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.

Time frame

From implantation through 12 months

Locations

This trial has no locations.

CSP-SOLIA-REGISTRY