Assessment of the Axone Micro Quadripolar Lead for Enhanced Cardiac Resynchronization Therapy

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the chronic safety and performance of the Axone left ventricular (LV) micro-lead.

Detailed Description
-----------------
This is a interventional, pivotal, prospective, single arm, open label, multicenter, international trial. The device under investigation is the Axone system, consisting of: Axone 4LV: an ultrathin, lumenless, quadripolar, IS4-compatible lead designed for left ventricular pacing for cardiac resynchronization therapy (CRT). Axone µGuide: a dedicated, permanently implantable micro catheter designed for implantation of the Axone 4LV lead. The primary endpoint data will be used to support CE marking of the Axone system. The primary endpoints will be evaluated at 6 months post-implantation. Subjects will be followed-up at 6 weeks, 3 months, 6 months, 12 months post-implantation, then yearly until 4 years post-implantation.

Official Title
-----------------
Assessment of the Axone Micro Quadripolar Lead for Enhanced Cardiac Resynchronization Therapy

Conditions
-----------------
Heart Failure, Cardiac Resynchronization Therapy

Intervention / Treatment
-----------------
* Device: Implantation of the Axone 4LV Lead


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for cardiac resynchronization therapy-defibrillator (CRT-D) device implant according to the latest ESC (European Society of Cardiology) guidelines De-novo implant of a Platinium 4LV CRT-D device (or any newer 4LV CRT-D model manufactured by MicroPort CRM) Reviewed, signed and dated informed consent form Exclusion Criteria: LV lead previous implant attempt Upgrade to CRT from a previously implanted pacemaker or implantable cardioverter-defibrillator (ICD), or CRT device replacement Known allergy to contrast media used for imaging during cardiac catheterization Tricuspid valvular disease or any type of tricuspid replacement heart valve (mechanical or tissue) Severe renal failure (creatinine clearance according to the Modification of Diet in Renal Disease (MDRD) formula < 30ml/min/m²) Active myocarditis Stroke, myocardial infarction or cardiac revascularization within 40 days prior to implant Previous heart transplant or currently on heart transplant list Life expectancy less than 1 year Already included in another clinical study that could confound the results of this study Pre-menopausal women / women in childbearing age, including pregnant and breastfeeding women Less than 18 years old or under guardianship Incapacitated subject, inability to understand the purpose of the study, or to meet follow-up visits at the implanting site as defined in the protocol Diagnosis of drug addiction (substance use disorder)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Axone 4LV Lead<br>Subjects implanted with the Axone 4LV Lead | Device: Implantation of the Axone 4LV Lead<br>* Implantation of the Axone 4LV Lead<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety co-primary endpoint, defined as Axone system related complication free rate at 6 months post implant | A complication is defined as any Serious Adverse Device Effect (SADE) resulting in death or requiring invasive intervention. Safety co-primary endpoint assessment will be based on independent event adjudication by a Clinical Event Committee (CEC). | 6 months | 
| Performance co-primary endpoint, defined as LV pacing success rate at 6 months post implant | LV pacing success is defined as at least one LV pacing vector with: Pacing Threshold (PT) ≤ 3.5V at 1ms pulse width, and No phrenic nerve stimulation at PT+2V / 1ms pulse width. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bizone LV pacing success rate at 6 months post implant | Bizone LV pacing success is defined as two distant pacing vectors with: A Pacing Threshold (PT) ≤ 3.5V at 1ms pulse width, and No phrenic nerve stimulation at PT +2V / 1ms pulse width. Two pacing vectors are considered distant when cathode electrodes are separated by at least 30 mm. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Left Ventricular Lead