Pilot study to evaluate the performance of a lead below 2 French with specific distal shape to deliver efficient LV pacing
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
39
Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy
Bordeaux University Hospital
Bordeaux, France
Clermont-Ferrand University Hospital
Clermont-Ferrand, France
Lille University Hospital
Lille, France
Rennes University Hospital
Rennes, France
LV Bi-zone pacing success rate
Percent of patients where the placement of the AXONE lead provides two distant LV pacing vectors matching: Pacing Threshold ≤ 3.5V/0.5ms.
Time frame: 30 min
LV pacing success rate
Percent of patients where the placement of the AXONE lead allows at least one LV pacing vectors matching: Pacing Threshold ≤ 3.5V/0.5ms.
Time frame: 30 min
Device or Implant testing procedure-related Adverse Events
Time frame: 1 month post intervention
Electrical performance (1)
LV pacing threshold (Volt)
Time frame: 30 min
Electrical performance (2)
LV pacing impedance (Ohm)
Time frame: 30 min
AXONE Implant Efficiency (1)
procedure time for successful placement
Time frame: 30 min
AXONE Implant Efficiency (2)
fluoroscopic time
Time frame: 30 min
AXONE Implant Efficiency (3)
radiation dose
Time frame: 30 min
AXONE Implant Efficiency (4)
handling assessment.
Time frame: 30 min
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Rouen University Hospital
Rouen, France
Hospital Universitari Germans Trias i Pujol
Badalona, Spain
Hospital Universitario y Politécnico La Fe
Valencia, Spain
LV multipoint pacing success
the placement of the AXONE provides two pacing vectors matching
Time frame: 30 min