Cardiac Interventional ICE Imaging Trial

NCT06344494 | Not Yet Recruiting

• 1 other identifier: INTELICE-CTP-2401
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Intracardiac echocardiography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Image quality

  Up to 48 hours

• Procedure success

  Up to 24 hours

• Technical success

  Up to 24 hours

• Procedure time

  Up to 24 hours

Other Outcomes (1)

• Device performance

  Up to 24 hours

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Arch EchoTM Intracardiac Ultrasound catheter and ultrasound system DEVICE

Novel ICE catheter and combined ultrasound system

Experimental group

SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system DEVICE

Commercially available devices

Control group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Requirement for ICE imaging of the heart;
• Requirement for ICE imaging of great vessels;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ICE Intelligent Healthcare Co., Ltd: lead

Study Sites (4)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Bejing, 100011, China

Location

The First People's Hospital of Changzhou

Changzhou, Jiangsu, 213004, China

Location

The First Hospital Of Jilin University

Changchun, Jilin, 130021, China

Location

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200081, China

Location

MeSH Terms

Conditions

Heart Septal Defects, Atrial; Foramen Ovale, Patent; Arrhythmias, Cardiac; Atrial Fibrillation; Tachycardia, Supraventricular; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Study Officials

• Deyong Long, MD, PhD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deyong Long, MD, PhD

CONTACT

64412431; dragon2008@vip.sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: April 3, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: April 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)