Status:
ACTIVE_NOT_RECRUITING
Assessment of the Axone Micro Quadripolar Lead for Enhanced Cardiac Resynchronization Therapy
Lead Sponsor:
MicroPort CRM
Conditions:
Heart Failure
Cardiac Resynchronization Therapy
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2027
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04463641
Start Date
December 3 2020
End Date
December 1 2027
Last Update
January 5 2024
Active Locations (21)
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1
Kepler Universitätsklinikum
Linz, Austria
2
CH Annecy Genevois
Annecy, France
3
CHRU Hopital Trousseau
Chambray-lès-Tours, France
4
CHU de Clermont-Ferrand
Clermont-Ferrand, France