Overview

The purpose of the clinical investigation is to evaluate the safety of the FLEXIGO delivery catheter for transvenous pacing lead implantation.

Eligibility

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 catheter
• Patient reviewed, signed and dated the ICF

Exclusion criteria (phase I):

• Patient planned for a device upgrade, or a device or a lead replacement
• Patient with a congenital heart disease
• Patient with significant hypertrophic cardiomyopathy, cardiac amyloidosis or obstructive hypertrophic cardiomyopathy
• Patient with a Left Ventricular Ejection Fraction (LVEF) ≤ 35%
• Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device)
• Patient implanted despite a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient contraindicated for a single dose of 310 μg of dexamethasone sodium phosphate, patient implanted with a tricuspid replacement heart valve, with prior tricuspid valve intervention or with a significant tricuspid valve disease that may lead to future replacement heart valve surgery)
• Minor age patient (i.e. under 18 years of age)
• Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation
• Non-menopausal women

Exclusion criteria (phase II):

• Patient planned for a device upgrade, or a device or a lead replacement
• Patient with a congenital heart disease
• Patient with significant hypertrophic cardiomyopathy, cardiac amyloidosis or obstructive hypertrophic cardiomyopathy
• Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device)
• Patient implanted despite a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient contraindicated for a single dose of 310 μg of dexamethasone sodium phosphate, patient implanted with a tricuspid replacement heart valve, with prior tricuspid valve intervention or with a significant tricuspid valve disease that may lead to future replacement heart valve surgery)
• Minor age patient (i.e. under 18 years of age)
• Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation
• Non-menopausal women