Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy

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

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

Conditions
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Cardiac Resynchronisation Therapy

Intervention / Treatment
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* Device: Implant test procedure


Participation Criteria
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Eligibility Criteria
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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%).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implant test procedure<br>Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy | Device: Implant test procedure<br>* Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LV Multizone pacing success rate | Percent of patients where the placement of the AXONE lead provides two distant LV pacing vectors matching Pacing Threshold ≤ 3.5V/0.5ms | 20 min | 
| LV pacing success rate | Percent of patients where the placement of the AXONE lead allows at least one LV pacing vector matching Pacing Threshold ≤ 3.5V/0.5ms | 20 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant testing Procedure-related Adverse Events procedure. |  | 1 month post testing | 
| Electrical performance of device (1) | Electrical performance focusing on LV pacing threshold (Volts) | 20 min | 
| Electrical performance of device (2) | Electrical performance focusing on LV pacing impedance (Ohm) | 20 min | 
| Lead Implant Efficiency | procedure time for successful placement | 20 min | 
| Lead Implant Efficiency | Radiation dose during implant | 20 min | 
| Satisfaction of implanter | handling assessment of implanter using satisfaction scale | 20 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quadripolar LV leads