Clinical trial NCT04156412: AXONE-Acute II: Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy
Official title: AXONE-Acute II: Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Resynchronisation Therapy
Keywords: quadripolar LV leads
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
Collaborators: name: MicroPort CRM
First posted: 2019-11-07
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Pilot study to evaluate the performance of a lead below 2 French with specific distal shape to deliver efficient LV pacing


Eligibility criteria: 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.

Exclusion Criteria:

* 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%.-

Primary outcomes:
measure: LV Bi-zone pacing success rate
timeFrame: 30 min
measure: LV pacing success rate
timeFrame: 30 min
Secondary outcomes:
measure: Device or Implant testing procedure-related Adverse Events
timeFrame: 1 month post intervention
measure: Electrical performance (1)
timeFrame: 30 min
measure: Electrical performance (2)
timeFrame: 30 min
measure: AXONE Implant Efficiency (1)
timeFrame: 30 min
measure: AXONE Implant Efficiency (2)
timeFrame: 30 min
measure: AXONE Implant Efficiency (3)
timeFrame: 30 min
measure: AXONE Implant Efficiency (4)
timeFrame: 30 min
measure: LV multipoint pacing success
timeFrame: 30 min
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Bordeaux University Hospital
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand University Hospital
city: Lille
country: France
facility: Lille University Hospital
city: Rennes
country: France
facility: Rennes University Hospital
city: Rouen
country: France
facility: Rouen University Hospital
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
Study officials:
affiliation: University Hospital, Rouen
name: Frédéric ANSELME, Pr
role: PRINCIPAL_INVESTIGATOR
References: