Clinical trial NCT06344494: Cardiac Interventional ICE Imaging Trial
Official title: The Cardiac Intervention Imaging Clinical Trial of an Intracardiac Ultrasound Catheter and Ultrasound System
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Structural Heart Diseases
Atrial Septal Defect
Patent Foramen Ovale
Arrhythmias, Cardiac
Atrial Fibrillation
Supraventricular Tachycardia
Valve Disease, Heart
Keywords: Intracardiac echocardiography
Lead sponsor: ICE Intelligent Healthcare Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-04-03
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Image quality
timeFrame: Up to 6 months
Secondary outcomes:
measure: Image quality
timeFrame: Up to 48 hours
measure: Procedure success
timeFrame: Up to 24 hours
measure: Technical success
timeFrame: Up to 24 hours
measure: Procedure time
timeFrame: Up to 24 hours
Other outcomes:
measure: Device performance
timeFrame: Up to 24 hours
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Bejing
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital Of Jilin University
state: Jilin
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
Study officials:
affiliation: Beijing Anzhen Hospital
name: Deyong Long, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: