Cardiac Interventional ICE Imaging Trial (INTELICE)

ICE Intelligent Healthcare

Status: Not yet enrolling

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

Treatments: Device: SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system; Device: Arch EchoTM Intracardiac Ultrasound catheter and ultrasound system

Study type: Interventional

Funder types: Industry

Identifiers

NCT06344494

INTELICE-CTP-2401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Experimental group

Experimental group

Description:

Subjects will undergo planned intracardiac interventional procedures utilizing the Arch EchoTM Intracardiac Ultrasound catheter and combined ultrasound system.

Treatment:

Device: Arch EchoTM Intracardiac Ultrasound catheter and ultrasound system

Control group

Active Comparator group

Description:

Subjects will undergo planned intracardiac interventional procedures utilizing the SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system.

Treatment:

Device: SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system