AXONE-Acute II: Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy (AXONE-Acute-2)

University Hospital, Rouen

Status

Completed

Conditions

Cardiac Resynchronisation Therapy

Treatments

Device: Implant test procedure

Study type

Interventional

Funder types

Other

Industry

Identifiers

2019/127/HP

Details and patient eligibility

About

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

Enrollment

39 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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%.-