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

@article{han2026cardiac,
  title = {{The cardiac intervention imaging clinical trial of an intracardiac ultrasound catheter and ultrasound system: the multicenter, randomized, INTELICE trial protocol.}},
  author = {Kangning Han and Caihua Sang and Minmin Sun and Mengmeng Li and Biao Fu and Tong Liu and Yang Yang and Songwen Chen and Shuyan Li and Ling Yang and Weipeng Zhao and Quan Li and Jihong Zhang and Simeng Liu and Yongzhen Cui and Ruoxi Zhang and Deyong Long and INTELICE study investigators},
  journal = {Trials},
  year = {2026},
  month = aug,
  doi = {10.1186/s13063-026-09845-7},
  url = {https://europepmc.org/article/MED/42958556},
  note = {CC BY-NC-ND},
}

TY  - JOUR
TI  - The cardiac intervention imaging clinical trial of an intracardiac ultrasound catheter and ultrasound system: the multicenter, randomized, INTELICE trial protocol.
AU  - Kangning Han
AU  - Caihua Sang
AU  - Minmin Sun
AU  - Mengmeng Li
AU  - Biao Fu
AU  - Tong Liu
AU  - Yang Yang
AU  - Songwen Chen
AU  - Shuyan Li
AU  - Ling Yang
AU  - Weipeng Zhao
AU  - Quan Li
AU  - Jihong Zhang
AU  - Simeng Liu
AU  - Yongzhen Cui
AU  - Ruoxi Zhang
AU  - Deyong Long
AU  - INTELICE study investigators
PY  - 2026
DA  - 2026/08/03
JO  - Trials
DO  - 10.1186/s13063-026-09845-7
UR  - https://europepmc.org/article/MED/42958556
AB  - Background  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.Methods  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.Discussion  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.Trial registration  ClinicalTrials.gov identifier: NCT06344494.
SN  - 1745-6215
ER  -