AXONE-Acute II: 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 II: 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 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%.-

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: Other
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 Bi-zone 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. | 30 min | 
| LV pacing success rate | Percent of patients where the placement of the AXONE lead allows at least one LV pacing vectors matching: Pacing Threshold ≤ 3.5V/0.5ms. | 30 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device or Implant testing procedure-related Adverse Events |  | 1 month post intervention | 
| Electrical performance (1) | LV pacing threshold (Volt) | 30 min | 
| Electrical performance (2) | LV pacing impedance (Ohm) | 30 min | 
| AXONE Implant Efficiency (1) | procedure time for successful placement | 30 min | 
| AXONE Implant Efficiency (2) | fluoroscopic time | 30 min | 
| AXONE Implant Efficiency (3) | radiation dose | 30 min | 
| AXONE Implant Efficiency (4) | handling assessment. | 30 min | 
| LV multipoint pacing success | the placement of the AXONE provides two pacing vectors matching | 30 min | 

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