NCT06453850
Recruiting
Not Applicable
Safety and Performance Evaluation of a New Catheter Range for Lead Implantation At Interventricular Septum
MicroPort CRM3 sites in 2 countries216 target enrollmentFebruary 14, 2025
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bradycardia
- Sponsor
- MicroPort CRM
- Enrollment
- 216
- Locations
- 3
- Primary Endpoint
- Absence of Unanticipated Serious Adverse Device Effect (USADE) related to FLEXIGO delivery catheter
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The purpose of the clinical investigation is to evaluate the safety of the FLEXIGO delivery catheter for transvenous pacing lead implantation.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Absence of Unanticipated Serious Adverse Device Effect (USADE) related to FLEXIGO delivery catheter
Time Frame: 72 hours after implantation
Any event caused by use of the FLEXIGO delivery catheter or any accessory packaged with the catheter, will be considered as an ADE related to the FLEXIGO delivery catheter. The primary endpoint evaluation will be based on Sponsor assessment of safety events, based on investigational site reporting.
Secondary Outcomes
- Left Bundle Branch Area Pacing (LBBAP) implantation success rate per indication (cardiac pacing and CRT) and per ventricular pacing lead model(During implantation)
- Implantation success rates(During implantation)
- Implantation usability(During implantation)
- Serious Adverse Device Effect (SADE) rate related to FLEXIGO delivery catheter or the slitter(72 hours after implantation)
- Implantation time(During implantation)
Study Sites (3)
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