CSP-SOLIA-REGISTRY
Brazilian Assessment of Technique, Utilization, QRS Response, and Long-term Electrical Performance of the Solia CSP Lead
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: André B Davila
- Phone Number: 55 48 9 91234886
- Email: grazydamasceno@clinicaritmo.com.br
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 months
|
|
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.
|
From implantation through 12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CSP-SOLIA-REGISTRY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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