Cardiac Resynchronization Therapy, Heart Failure
Conditions
Keywords
Left Ventricular Lead
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.
Interventions
DEVICEImplantation of the Axone 4LV Lead
Implantation of the Axone 4LV Lead
Sponsors
MicroPort CRM
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety co-primary endpoint, defined as Axone system related complication free rate at 6 months post implant | 6 months | 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). |
| Performance co-primary endpoint, defined as LV pacing success rate at 6 months post implant | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bizone LV pacing success rate at 6 months post implant | 6 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fluoroscopy dose | At implant, preferably within 15 days of enrollment | Fluoroscopy dose is measured using dose area product (Gray.cm\^2) |
| Axone system handling assessment | At implant, preferably within 15 days of enrollment | Implanters will be asked to fill in a handling questionnaire and record observations related to the use of the Axone system. |
| Axone implanters' learning curve | At implant, preferably within 15 days of enrollment | This endpoint will be based on fluoroscopy time for implantation. The effect of removing the 1st, 2nd, 3rd, etc implanted subjects on mean fluoroscopy time (per implanter and per site) will be calculated. |
| Number of excitable myocardium areas at implant | At implant, preferably within 15 days of enrollment | Excitable myocardium areas are areas that can be paced by the implanted Axone 4LV lead. |
| Effect of CRT therapy, in particular bizone pacing, on QRS parameters, at discharge and 6 months post implant | At discharge, within 7 days of implant, and at 6 months | The effect of monozone and bizone CRT pacing on duration of QRS is measured in milliseconds. |
| Effect of CRT therapy, in particular bizone pacing, on Left Pre-Ejection Interval (LPEI), at discharge | At discharge, within 7 days of implant | LPEI (in milliseconds) is an electromechanical parameter that can be assessed using echocardiography. |
| Axone 4LV implantation success rate | At implant, preferably within 15 days of enrollment | — |
| Axone 4LV lead pacing impedance | Discharge (within 7 days of implant), 6 weeks, 3 months, 6 months, 12 months, 24 months 36 months, 48 months | Pacing impedance is measured in Ohms. |
| Presence of phrenic nerve stimulation (PNS) with the Axone 4LV lead | Implant (preferably within 15 days of enrollment), discharge (within 7 days of implant), 6 weeks, 3 months, 6 months | The presence of PNS will be assessed at 10V using an external pacing system analyzer at implant, or at pacing threshold +2V at other visits. |
| Axone 4LV lead programming | Discharge (within 7 days of implant), 6 weeks, 3 months, 6 months, 12 months, 24 months 36 months, 48 months | Lead programming will be reported using: (i) pacing amplitude (Volts), pulse width (milliseconds) and pacing vector(s) selected. |
| Energy consumption associated with Axone 4LV lead | 6 months | Energy will be calculated using the formula: E=(pacing amplitude\^2 x pulse width)/impedance. Energy, pacing amplitude, pulse width and impedance are measured in Joules, Volts, milliseconds, and Ohms, respectively. |
| Axone system-related annual complication-free rate | 12 months, 24 months 36 months, 48 months | Definition of Axone system related complication is the same as for primary safety endpoint. |
| Clinical response to CRT at 12 months post implant | 12 months | Clinical response will be determined by looking at functional improvement, reverse remodelling, freedom from heart failure events, and rate of non-responders: (i) functional improvement is defined as improvement in ≥1 NYHA (New York Heart Association) class from baseline to 12 months. (ii) reverse remodelling is a ≥12% increase in left ventricular end systolic volume index (LVESVi: LVESV \[mL\] and body surface area \[m\^2\] will be combined to report LVESVi). (iii) freedom from heart failure events is defined as an absence of death or HF hospitalization. (iv) non-responders are all those who are not responders. A responder is defined as a subject that is not dead and who did not experience any HF hospitalization and that has a stable or improved NYHA class versus baseline. |
| Axone 4LV lead pacing threshold | Discharge (within 7 days of implant), 6 weeks, 3 months, 6 months, 12 months, 24 months 36 months, 48 months | Pacing threshold is measured in Volts. |
| Implantation duration | At implant, preferably within 15 days of enrollment | — |
| Fluoroscopy time | At implant, preferably within 15 days of enrollment | Fluoroscopy time is measured in minutes |
Countries
Austria, France, Germany, Italy, Netherlands, Portugal, Spain
Outcome results
None listed