Study design
ADVERSE EVENTS
ACCESS was an investigator-led, interventional, prospective, single centre, randomized, and controlled superiority trial. Patients were randomized in a 1:1 ratio to receive vascular access with either IPUS-AVP (investigational arm) or CVC (control arm) as a first assigned route. Randomization was stratified according to the number of leads to be implanted (single- or dual-chamber device).The trial was funded by the Hospices Civils de Lyon and was conducted in accordance with the Declaration of Helsinki and the International Council for Harmonisation Good Clinical Practice Guidelines. Data collection was managed and monitored by an independent team from the Department of Clinical Research and Innovation of the Hospices Civils de Lyon. In view of the low risk of serious adverse events associated with this research, no other committee was required for this study. The protocol was approved by the local ethic committee (CPP Sud-Ouest et Outre-mer, 31 March 2020) and was registered at ClinicalTrials.gov with number NCT04649788.