NCT05668377

Brief Summary

The study is to evaluate the performance of the PulseAI neural network technology at interpreting ECG data recorded using a single-lead Smartwatch (Apple Watch).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 29, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

December 29, 2022

Status Verified

December 1, 2022

Enrollment Period

1 year

First QC Date

September 29, 2022

Last Update Submit

December 20, 2022

Conditions

Arrhythmias, Cardiac

Outcome Measures

Primary Outcomes (1)

  • Evaluate the performance of arrhythmia detection.

    Evaluate the performance of arrhythmia detection by the PulseAI neural network applied to ECG data collected via the Smartwatch compared to physicians' interpretation of the 12-lead ECG.

    12 months

Secondary Outcomes (2)

  • Evaluate the performance of the Apple Watch ECG interpretation Software compared to the PulseAI software

    12 months

  • Evalaute the performance of QTc interval measurement

    12 months

Interventions

PulseAI ECG PlatformDEVICE

Cloud-based AI-enabled ECG analysis platform

Eligibility Criteria

Age22 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants hospitalised for ablation, cardioversion or cardiac rhythm consultation.

You may qualify if:

  • Patient aged 22 or older, able and willing to participate in the study
  • Patient admitted to hospital for ablation, cardioversion, or cardiac electrophysiological exploration.
  • Patient who has read the information note and has given their consent before any procedure related to the study.

You may not qualify if:

  • Patient with a pacemaker, implantable defibrillator or cardiac resynchronisation therapy device.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beacon Hospital Research Institute

Dublin, Ireland

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David Burke, PhD

    Beacon Hospital Research Institute, Dublin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alan Kennedy, PhD

CONTACT

07714640144alan.kennedy@pulseai.io

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2022

First Posted

December 29, 2022

Study Start

January 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

December 29, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

IE(1)