Implantation of the Axone 4LV Lead: Implantation of the Axone 4LV Lead
Study summary
The primary objective of this study is to assess the chronic safety and performance of the Axone left ventricular (LV) micro-lead.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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)
Primary outcome measure(s)
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.
Trial sites (21)
Facility
City
Region
Status
Kepler Universitätsklinikum
Linz
Austria
CH Annecy Genevois
Annecy
France
CHRU Hopital Trousseau
Chambray-lès-Tours
France
CHU de Clermont-Ferrand
Clermont-Ferrand
France
CHU Grenoble
Grenoble
France
CHRU de Lille - Hôpital Cardiologique
Lille
France
CHU Pontchaillou
Rennes
France
CHU de Rouen
Rouen
France
CHU Toulouse
Toulouse
France
Universitätsklinikum Hamburg Eppendorf
Hamburg
Germany
Universitätsklinikum Heidelberg
Heidelberg
Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel
Germany
ASST Spedali Civili di Brescia
Brescia
Italy
Ospedale Pellegrini
Naples
Italy
Ospedale Policlinico Federico II
Naples
Italy
Isala Klinieken
Zwolle
Netherlands
Centro Hospitalar Universitário Lisboa Norte - Hospital de Santa Maria
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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