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NCT05874128 · ClinicalTrials.gov registry record · NA
Prospective Evaluation OF Heartfocus
A NA study of Cardiac Disease, sponsored by DESKi.
- Completed
- Registry status
- NA
- Development phase
- 240
- Enrollment target
- 2
- Study locations
NCT05874128: Completed NA study of Cardiac Disease, sponsored by DESKi.
NCT05874128 is a NA study of Cardiac Disease that has completed, run by DESKi. The registered enrollment target is 240 participants, below the 812-participant average among 24 other Cardiac Disease trials with a reported enrollment target (70% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05874128, a NA study of Cardiac Disease, has completed, sponsored by DESKi.
- COMPLETED
- Registry status
- NA
- Development phase
- 240 participants
- Enrollment target
- 2
- Study locations
Study Summary
The study's objective is to evaluate if exams, performed with the HeartFocus software by novices, are of sufficient quality to visually analyze the left ventricular size, the left ventricular function, the right ventricular size, and the presence of non-trivial pericardial effusion. Novices will be nurses without prior ultrasound experience who have received dedicated training on cardiac ultrasound and on Heartfocus software. Ultrasound exams will be limited to the acquisition of 10 reference views
Primary Outcome
For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the exam had sufficient image quality to allow visual analysis of left ventricular size. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as "Yes" (sufficient quality), the exam was classified as having sufficient image
Conditions Studied
Interventions
- DEVICE Using HeartFocus software with AI guidance (Novices)
- DEVICE Using HeartFocus software without AI-guidance
Study Locations (2)
New York
- Lenox Hill Hospital - New York
Aquitaine
- University Hospital of Bordeaux - Bordeaux
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2023-11-13 |
| Est. Completion | 2024-08-16 |
| Phase | NA |
What the finished NCT05874128 record still lists
NCT05874128 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 812-participant average among 24 other Cardiac Disease trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Cardiac Disease appearing as the primary indexed condition, and to 2 interventions - of which Using HeartFocus software with AI guidance (Novices) is the first listed.
NCT05874128 reports a single indexed study location in New York, Aquitaine.
Frequently Asked Questions
What is clinical trial NCT05874128 about?
NCT05874128 is a clinical study titled "Prospective Evaluation OF Heartfocus". The study's objective is to evaluate if exams, performed with the HeartFocus software by novices, are of sufficient quality to visually analyze the left ventricular size, the left ventricular function, the right ventricular size, and the presence of non-trivial pericardial effusion. Novices will be...
What is the current status of trial NCT05874128?
This trial is currently completed. It is a NA study. The enrollment target is 240 participants. The study started on 2023-11-13. Estimated completion is 2024-08-16.
What conditions does trial NCT05874128 study?
This clinical trial studies the following conditions: Cardiac Disease.
What interventions are being tested in trial NCT05874128?
The interventions under investigation include: Using HeartFocus software with AI guidance (Novices) (DEVICE), Using HeartFocus software without AI-guidance (DEVICE).
Who is sponsoring clinical trial NCT05874128?
This trial is sponsored by DESKi, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05874128 being conducted?
This trial has 2 study locations across New York, Aquitaine. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05874128's enrollment target sits among peer trials
240 9th of 24 higher than 16 of 24 other Cardiac Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiac Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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