Validation of a Smartphone-based Recorder for Detection of Cardiac Arrhythmias

NCT03996954 | Unknown FDA Device

• 1 other identifier: IRAS Project ID:245687
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will evaluate the diagnostic yield of the new AliveCor device versus a 12 lead ECG when used simultaneously to detect cardiac arrhythmia

Conditions

Cardiac Arrhythmia

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of alivecor recording

  For each patient two diagnoses of their underlying heart rhythm will be provided by blinded reporters. The percentage match of these diagnoses (the ratio of identical diagnoses to mismatch in diagnoses between ECG report and Alivecor report will be used as a measure of accuracy of the Alivecor to differentiate between different heart rhythms, using the 12 lead ECG as the gold standard for cardiac rhythm diagnosis.

  Diagnostic accuracy of Alivecor recording at the end of the study which will be 2 years after study start date.

Study Arms (2)

Normal ECGs

ACTIVE COMPARATOR

Patients with normal ECGs

Device: Alivecor recording

Abnormal ECGs

ACTIVE COMPARATOR

Patients with different kinds of abnormal heart rhythms will be enrolled in order to compare whether Alivecor can accurately differentiate between these abnormal heart rhythms and normal sinus rhythm/sinus tachycardia. Also, Alivecor diagnostic accuracy in differentiating between different kinds of arrhythmias will be assessed.

Device: Alivecor recording

Interventions

Alivecor recording DEVICE

Alivecor recording and ECG recording from the same patient in very close temporal proximity

Abnormal ECGs; Normal ECGs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients \>18 years
• lead ECG finding of arrhythmia, manifest pre-excitation, pacing rhythm (in the EP lab), sinus rhythm or sinus tachycardia

You may not qualify if:

• Age \<18 years
• Patients unable to or unwilling to use the device
• Patients with cardiac pacemaker, ICDs, or other implanted electronic devices

Sponsors & Collaborators

• Blackpool Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Blackpool Teaching Hospitals NHS Foundation Trust

Blackpool, Lancashire, FY3 8NR, United Kingdom

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Khalid Abozguia, Ph.D.

  Blackpool Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Khalid Abozguia, Ph.D.

CONTACT

00441253957780; k.abozguia@nhs.net

Dimitrios Katsaras, MD

CONTACT

00441253957780; d.katsaras@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiologist and Electrophysiologist

Model Details: Recordings with Alivecor and 12 lead ECGs with be acquired from patients with known arrhythmias/normal heart rhythm and blinded physicians will report on recordings and ECGs. Reports for each patient will be compared at the end of the study in order to assess diagnostic accuracy of the Alivecor to detect and differentiate between different kinds of abnormal heart rhythms.

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: June 25, 2019
• Study Start: October 8, 2018
• Primary Completion: October 7, 2020
• Study Completion: October 7, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)