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
DEVICE_FEASIBILITY
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 guidelines . * Primary implant of a CRT device (including upgrade from a single or dual-chamber pacemaker or ICD). * Signed and dated informed consent. * Patient affiliated with, or beneficiary of a social security category.
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 \< 30ml/mn/m²). * Previous failure 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. * Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision). * Known pregnancy, breastfeeding women or in childbearing age without an adequate contraceptive method (failure rate \< 1%).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LV Multizone pacing success rate | 20 min | Percent of patients where the placement of the AXONE lead provides two distant LV pacing vectors matching Pacing Threshold ≤ 3.5V/0.5ms |
| LV pacing success rate | 20 min | Percent of patients where the placement of the AXONE lead allows at least one LV pacing vector matching Pacing Threshold ≤ 3.5V/0.5ms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant testing Procedure-related Adverse Events procedure. | 1 month post testing | — |
| Electrical performance of device (1) | 20 min | Electrical performance focusing on LV pacing threshold (Volts) |
| Electrical performance of device (2) | 20 min | Electrical performance focusing on LV pacing impedance (Ohm) |
| Lead Implant Efficiency | 20 min | procedure time for successful placement |
| Satisfaction of implanter | 20 min | handling assessment of implanter using satisfaction scale |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORFrédéric ANSELME, Pr
University Hospital, Rouen
Outcome results
None listed