The cardiac intervention imaging clinical trial of an intracardiac ultrasound catheter and ultrasound system: the multicenter, randomized, INTELICE trial protocol

Intracardiac echocardiography (ICE) plays an increasingly important role in guiding cardiac interventional procedures. However, evidence from randomized studies comparing different ICE catheter systems is limited, and standardized criteria for ICE image quality assessment are lacking. The INTELICE trial is designed to evaluate the efficacy and safety of a novel Arch Echo™ intracardiac ultrasound catheter and ultrasound system compared with a commercially available ICE system. INTELICE is a prospective, multicenter, randomized, open-label, non-inferiority clinical trial with blinded outcome evaluation. Adult patients undergoing cardiac interventional procedures requiring ICE guidance are eligible for enrollment. Participants are randomized in a 1:1 ratio to receive either the Arch Echo™ ICE catheter with its dedicated ultrasound system or the ACUSON AcuNav catheter paired with the P500 ultrasound system. A standardized ICE imaging protocol is applied across all participating centers. The primary endpoint is ICE image quality, assessed using a predefined 1–5 scoring system by independent core-laboratory sonographers who are blinded to device allocation. Secondary endpoints include operator-assessed image quality, procedural success, catheter delivery to target positions, procedure duration, and safety outcomes. The INTELICE trial will provide high-quality comparative evidence on ICE image performance and procedural safety between a novel ICE catheter system and an established commercial device. In addition, this study aims to establish standardized criteria for ICE image quality assessment and to explore differences between operator-based and sonographer-based evaluations, which may improve the consistency and reliability of ICE-guided cardiac interventions. ClinicalTrials.gov identifier: NCT06344494.