AXONE-Acute II: Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy

AXONE-Acute II: Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy

Pilot study to evaluate the performance of a lead below 2 French with specific distal shape to deliver efficient LV pacing

Inclusion Criteria:

• Male or female patient aged ≥18 years old.
• Patient presenting a CRT-P or CRT-D indication according to the latest ESC guidelines1.
• Primary implant of a CRT device (including upgrade from a single or dual-chamber pacemaker or ICD).
• Signed and dated informed consent.

Exclusion Criteria:

• Class IV of NYHA (ambulatory or not).
• Allergy to contrast media used for imaging during cardiac catheterization.
• Severe Renal Failure (clearance of creatinine according to Modification of diet in renal disease formula (MDRD) < 30ml/mn/m²).
• Previous failure of catheterization of the coronary sinus, or previous failure of left ventricular lead implantation.
• Already included in another clinical study involving intra-cardiac active implantable device, or participation to any other clinical trial in the last 2 weeks.
• Vulnerable patient such as person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision).
• Known pregnancy, breastfeeding or women in childbearing age without an adequate contraceptive method with a known failure rate < 1%.-