Informations générales (source: ClinicalTrials.gov)
AXONE-Acute II: Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy (AXONE-Acute-2)
Interventional
N/A
University Hospital, Rouen (Voir sur ClinicalTrials)
janvier 2020
octobre 2020
29 juin 2024
Pilot study to evaluate the performance of a lead below 2 French with specific distal
shape to deliver efficient LV pacing
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Lille University Hospital - Lille - France | Didier KLUG, Pr | Contact (sur clinicalTrials) | |||
| Rouen University Hospital - Rouen - France | Frédéric ANSELME, Pr | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Bordeaux University Hospital - Bordeaux - France | Philippe RITTER, Pr | Contact (sur clinicalTrials) | |||
| Clermont-Ferrand University Hospital - Clermont-Ferrand - France | Frédéric Jean, MD | Contact (sur clinicalTrials) | |||
| Rennes University Hospital - Rennes - France | Christophe LECLERCQ, Pr | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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%.-