Future Directions
A clinical trial has now begun on a defibrillator version of this lead
(ClinicalTrials.gov Identifier: NCT04863664). In this trial the lead
will be used in a standard endocardial position in the right ventricle.
This next generation defibrillator lead is 4.7 French in diameter and
utilizes a single right ventricular ICD coil as the outer conductor.
Sensing is thus obligatorily from tip to coil. Standard measures of
efficacy will be measured including the defibrillation threshold and
lead diagnostics. This trial also uses an interesting approach of
coupling “virtual patients” that represent data from rigorous
engineering bench evaluation that has been demonstrated to be able to
predict lead conductor failure