Assessment of the Axone Micro Quadripolar Lead for Enhanced Cardiac Resynchronization Therapy

Prior treatment

• LV lead previous implant attempt
• Upgrade to CRT from a previously implanted pacemaker or implantable cardioverter-defibrillator (ICD), or CRT device replacement
• Stroke, myocardial infarction or cardiac revascularization within 40 days prior to implant
• Previous heart transplant or currently on heart transplant list

Other illness

• Known allergy to contrast media used for imaging during cardiac catheterization
• Tricuspid valvular disease or any type of tricuspid replacement heart valve (mechanical or tissue)
• Diagnosis of drug addiction (substance use disorder)

Lab values

• Severe renal failure (creatinine clearance according to the Modification of Diet in Renal Disease (MDRD) formula \< 30ml/min/m²)

Age

• Pre-menopausal women / women in childbearing age, including pregnant and breastfeeding women
• Less than 18 years old or under guardianship

Other

• Active myocarditis
• Life expectancy less than 1 year
• Already included in another clinical study that could confound the results of this study
• Incapacitated subject, inability to understand the purpose of the study, or to meet follow-up visits at the implanting site as defined in the protocol

• Indication for cardiac resynchronization therapy-defibrillator (CRT-D) device implant according to the latest ESC (European Society of Cardiology) guidelines
• De-novo implant of a Platinium 4LV CRT-D device (or any newer 4LV CRT-D model manufactured by MicroPort CRM)
• Reviewed, signed and dated informed consent form