safety and performance evaluation of a new catheter range for lead implantation at interventricular septum

Conditions: Bradycardia; Cardiac Resynchronization Therapy; Left Bundle Branch Area Pacing

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 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