Blinded Randomized Controlled Trial of Artificial Intelligence Guided Detection of Intracardiac Thrombus

January 4, 2024 updated by: Xu Liu, Shanghai Chest Hospital

ICE Detector-RCT: Blinded, Randomized Controlled Trial of Electrophysiologist vs. Artificial Intelligence Detection of Intracardiac Thrombus

To determine whether an integrated AI decision support can save time and improve the accuracy of detection of intracardiac thrombus, the investigators are conducting a blinded, randomized controlled study of AI-guided detection of intracardiac thrombus to electrophysiologist judgment in preliminary readings of echocardiograms.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • 上海市
      • Shanghai, 上海市, China, 200030
        • Shanghai Chest Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Aged 18-80 years.
  2. Willing to sign informed consent.
  3. Patients diagnosed with atrial fibrillation Paroxysmal AF and Persistent AF according to the latest clinical guidelines

Exclusion Criteria:

  1. End-stage disease with a mean life expectancy less than 1 year
  2. New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction less than 30%
  3. Previous surgical or catheter ablation for AF
  4. Bradycardia and presence of implanted ICD
  5. Uncontrolled hypertension: Systolic blood pressure (SBP) >180 mmHg or diastolic blood pressure (DBP) > 110 mmHg
  6. Patients with Cardiovascular events including acute myocardial infarction, any PCI, valvular cardiac surgical, or percutaneous procedure within the past 3 months
  7. Women of childbearing potential who are, or plan to become, pregnant during the time of the study
  8. Have been enrolled in an investigational study evaluating devices or drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Electrophysiologist judgment
Other: Electrophysiologist judgment of the intracardiac thrombus
Cardiac electrophysiologists use their own experience to determine whether there is intracardiac thrombus
Experimental: Artificial Intelligence Detection
Other: Automated detection of the intracardiac thrombus through deep learning
A deep learning model will identify the intracardiac thrombus. The AI model will produce an assessment of intracardiac thrombus using video based features.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Degree of change from initial (AI vs EP doctor) assessment to final cardiologist assessment
Time Frame: 10 Minutes
10 Minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Perioperative adverse event rates
Time Frame: 10 Minutes
10 Minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Chest Hospital

Collaborators

Johnson & Johnson

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 5, 2024

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 4, 2024

First Submitted That Met QC Criteria

January 4, 2024

First Posted (Actual)

January 16, 2024

Study Record Updates

Last Update Posted (Actual)

January 16, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICE Detector-RCT

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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