Safety and Performance Evaluation of a New Catheter Range for Lead Implantation At Interventricular Septum
Trial Parameters
Brief Summary
The purpose of the clinical investigation is to evaluate the safety of the FLEXIGO delivery catheter for transvenous pacing lead implantation.
Eligibility Criteria
Inclusion criteria (phase I): * Patient indicated for cardiac pacing according to the most recent guidelines from the European Society of Cardiology (ESC) * Patient planned for a de novo implantation of any Single Chamber (SR) or Dual Chamber (DR) CE marked pacemaker * Patient planned for a catheter-guided implantation in the interventricular septum area * Patient planned for the implantation of any CE marked ventricular pacing lead compatible with the FLEXIGO delivery catheter * Patient reviewed, signed and dated the Informed Consent Form (ICF) Inclusion criteria (phase II): * Patient indicated for cardiac pacing or CRT according to the most recent guidelines from the ESC * Patient planned for a de novo implantation of any SR or DR CE marked pacemaker, or any CE marked CRT-D * Patient planned for a catheter-guided implantation in the interventricular septum area * Patient planned for the implantation of any CE marked ventricular pacing lead compatible with the FLEXIGO delivery cathete