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Cardiac Interventional ICE Imaging Trial

NCT06344494 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2024-04-04

No results posted yet for this study

Summary

The INTELICE trial is a prospective, multicenter, 1:1 randomized controlled non-inferiority study. It aims to compare a novel intracardiac echography (ICE) catheter and combined ultrasound system with existing commercial ones. The evaluation will be conducted on patients undergoing planned intracardiac interventional process.

Conditions

  • Structural Heart Diseases
  • Atrial Septal Defect
  • Patent Foramen Ovale
  • Arrhythmias, Cardiac
  • Atrial Fibrillation
  • Supraventricular Tachycardia
  • Valve Disease, Heart

Interventions

DEVICE

Arch EchoTM Intracardiac Ultrasound catheter and ultrasound system

Novel ICE catheter and combined ultrasound system

DEVICE

SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system

Commercially available devices

Sponsors & Collaborators

  • ICE Intelligent Healthcare Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Deyong Long, MD, PhD · Beijing Anzhen Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2025-05-31
Completion
2026-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06344494 on ClinicalTrials.gov