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Surface ECG Signal Recording for the Implantable Subcutaneous String Defibrillator (ISSD) Detection Algorithm Performance Assessment

NCT03408951 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 91

Last updated 2019-08-21

No results posted yet for this study

Summary

Recorded cutaneous ECG containing arrhythmia events are separately analysed by an expert Electrophysiologist and the ISSD detection algorithm, to allow assessment of the correct detection of tachyarrhythmia events and discrimination of supra-ventricular arrhythmia of the algorithm,m compared to the expert.

Conditions

  • Tachyarrhythmia
  • Arrhythmias, Cardiac

Interventions

OTHER

Recording

The patient cutaneous ECG is recorded, to later be comparatively analysed by an expert and by the ISSD detection algorithm

Sponsors & Collaborators

  • NewPace Ltd

    lead INDUSTRY

Principal Investigators

  • Joseph H Levine, M.D · St Francis Hospital Heart Center

  • David Hoch, M.D · St Francis Hospital Heart Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-02
Primary Completion
2018-12-05
Completion
2018-12-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03408951 on ClinicalTrials.gov