Cardiac Resynchronisation Therapy
Conditions
Keywords
quadripolar LV leads
Brief summary
Pilot study to evaluate the performance of a lead below 2 French with specific distal shape to deliver efficient LV pacing
Interventions
DEVICEImplant test procedure
Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy
Sponsors
University Hospital, Rouen
MicroPort CRM
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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%.-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LV pacing success rate | 30 min | Percent of patients where the placement of the AXONE lead allows at least one LV pacing vectors matching: Pacing Threshold ≤ 3.5V/0.5ms. |
| LV Bi-zone pacing success rate | 30 min | Percent of patients where the placement of the AXONE lead provides two distant LV pacing vectors matching: Pacing Threshold ≤ 3.5V/0.5ms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AXONE Implant Efficiency (3) | 30 min | radiation dose |
| AXONE Implant Efficiency (4) | 30 min | handling assessment. |
| LV multipoint pacing success | 30 min | the placement of the AXONE provides two pacing vectors matching |
| Device or Implant testing procedure-related Adverse Events | 1 month post intervention | — |
| Electrical performance (1) | 30 min | LV pacing threshold (Volt) |
| AXONE Implant Efficiency (1) | 30 min | procedure time for successful placement |
| Electrical performance (2) | 30 min | LV pacing impedance (Ohm) |
| AXONE Implant Efficiency (2) | 30 min | fluoroscopic time |
Countries
France, Spain
Contacts
PRINCIPAL_INVESTIGATORFrédéric ANSELME, Pr
University Hospital, Rouen
Outcome results
None listed