Implant test procedure
DeviceImplant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy
NCT Number: NCT03750058
Pilot study to evaluate the performance of a lead below 2 French with specific distal shape to deliver efficient LV pacing
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Bordeaux University Hospital, Bordeaux, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy
Time frame: 20 min
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: 20 min
Percent of patients where the placement of the AXONE lead allows at least one LV pacing vector matching Pacing Threshold ≤ 3.5V/0.5ms
Time frame: 1 month post testing
Time frame: 20 min
Electrical performance focusing on LV pacing threshold (Volts)
Time frame: 20 min
Electrical performance focusing on LV pacing impedance (Ohm)
Time frame: 20 min
procedure time for successful placement
Time frame: 20 min
Radiation dose during implant
Time frame: 20 min
handling assessment of implanter using satisfaction scale
University Hospital, Rouen
Other
AXONE -Acute : Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy
Acronym: AXONE-Acute
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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