Cardiac Interventional ICE Imaging Trial (INTELICE)

The Cardiac Intervention Imaging Clinical Trial of an Intracardiac Ultrasound Catheter and Ultrasound System

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation; Arrhythmias, Cardiac; Atrial Septal Defect; Patent Foramen Ovale; Valve Disease, Heart; Supraventricular Tachycardia; Structural Heart Diseases
• Intervention / Treatment: Device: Arch EchoTM Intracardiac Ultrasound catheter and ultrasound system; Device: SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system

Detailed Description

This randomized controlled trial will enroll adult patients undergoing cardiac interventions, who will be randomly assigned to either the experimental device group or the control group.

The main endpoint of the INTELICE trial is the image quality rate of intracardiac echocardiography, which will be evaluated by three experienced sonographers from the core laboratory, while the operator's image quality assessment serves as a secondary endpoint. In addition, secondary endpoints include clinical success rate, technical success rate, procedure time, and evaluation for the experimental devices.

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deyong Long, MD, PhD; Phone Number: 0086010 64412431; Email: dragon2008@vip.sina.com

Study Locations

• China
  • Bejing
    • Beijing, Bejing, China, 100011
      • Beijing AnZhen Hospital, Capital Medical University
      • Contact: Deyong Long, MD, PhD; Phone Number: 0086010 64412431; Email: dragon2008@vip.sina.com
      • Sub-Investigator: Ribo Tang, MD, PhD
  • Jiangsu
    • Changzhou, Jiangsu, China, 213004
      • The First People's Hospital of Changzhou
      • Contact: Ling Yang, MD; Phone Number: 00860519 68873108; Email: Yangling369@czfph.com
      • Principal Investigator: Ling Yang, MD
      • Sub-Investigator: Bo Qian, MD
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
      • Contact: Shuyan Li, MD, PhD; Phone Number: 00860431 88782222; Email: shuyanli1992@163.com
      • Principal Investigator: Shuyan Li, MD, PhD
      • Sub-Investigator: Hongbo Meng
  • Shanghai
    • Shanghai, Shanghai, China, 200081
      • Shanghai General Hospital
      • Contact: Songwen Chen, MD, PhD; Phone Number: 0086 18017638339
      • Principal Investigator: Songwen Chen, MD, PhD
      • Sub-Investigator: Juan Sun

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years, ≤90 years, of any gender.

• Subjects deemed suitable for the utilization of ICE catheters during cardiac interventional procedures, as determined by investigators:

  1. Requirement for ICE imaging of the heart;
  2. Requirement for ICE imaging of great vessels;
  3. Requirement for ICE imaging of other intracardiac devices.
• Subjects themselves or their guardians must possess the ability to comprehend the purpose of this study, demonstrate adequate compliance with the protocol, and sign the informed consent form.

Exclusion Criteria:

• Anticipated vascular access (e.g., femoral vein, inferior vena cava, subclavian vein, internal jugular vein) cannot meet the procedure needs.
• PLT <100*109/L or INR >1.5.
• Intracardiac blood clots or severe peripheral vascular disease (e.g., deep vein thrombosis, aneurysm, atherosclerosis).
• Sepsis, pyemia, or severe systemic infection.
• NYHA Class IV.
• History of cardiac or related cardiac areas surgery within 6 months.
• Inability to tolerate post procedure oral anticoagulants or antiplatelet drugs.
• Inability to tolerate or cooperate with the procedure.
• Pregnant or lactating women, women with a positive pregnancy test result within 7 days before enrollment.
• Participation in other clinical trials of drugs, biological agents or devices within 3 months before screening.
• Other exclusive circumstances determined by the investigators, where the subject is deemed unsuitable for enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Subjects will undergo planned intracardiac interventional procedures utilizing the Arch EchoTM Intracardiac Ultrasound catheter and combined ultrasound system.	Device: Arch EchoTM Intracardiac Ultrasound catheter and ultrasound system; Novel ICE catheter and combined ultrasound system
Active Comparator: Control group; Subjects will undergo planned intracardiac interventional procedures utilizing the SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system.	Device: SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system; Commercially available devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Image quality	The image quality will be assessed by three cardiac sonographers. Sonographers will score based on image parameters such as image clarity, penetration, temporal and spatial resolution, blood flow, etc. The evaluation with utilize a 1-5 scale scoring system. A score of 5 indicates that the images are excellent and suitable for clinical needs, while a score of 4 suggests good quality. 3 indicates that the image has flaws but still meets the clinical needs. Scores of 1 and 2 signify poor or bad image quality, which can affect clinical diagnosis and treatment.	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Image quality	Adequate image quality will be assessed by the operators using the same evaluation criteria as the sonographers. However, the operator's responses are simplified and not encompass all different modes of ultrasound.	Up to 48 hours
Procedure success	Interventional procedure success rate.	Up to 24 hours
Technical success	Success delivery of ICE catheters to the target position. The operator aims to visualize a particular heart structure and requires the ICE catheter to be positioned at a specific site, such as the right atrium, right ventricular including outflow tract or left atrium, etc. The determination of whether the catheter has been successfully delivered to target locations is made by the operators.	Up to 24 hours
Procedure time	The time from vascular puncture to completion.	Up to 24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device performance	Device performance evaluation by the investigator. The assessment will primarily focus on catheter parameters including deliverability, deflectability, compatibility, etc. A scoring system will be employed, where 5 points indicate the highest level of satisfaction, 3 points signify meeting the minimum requirements, and 1 or 2 points indicate dissatisfaction.	Up to 24 hours

Collaborators and Investigators

• Sponsor: ICE Intelligent Healthcare Co., Ltd
• Investigators: Principal Investigator: Deyong Long, MD, PhD, Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: March 14, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Intracardiac echocardiography
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Congenital Abnormalities; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects; Heart Diseases; Atrial Fibrillation; Arrhythmias, Cardiac; Tachycardia; Heart Septal Defects, Atrial; Heart Valve Diseases; Foramen Ovale, Patent; Tachycardia, Supraventricular
• Other Study ID Numbers: INTELICE-CTP-2401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No