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.
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 Type
OBSERVATIONAL
Enrollment
300
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.
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
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
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