Safety and Performance Evaluation of a New Catheter Range for Lead Implantation At Interventricular Septum

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