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

Completed

Conditions studied: Tachyarrhythmia, Arrhythmias, Cardiac

In brief

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.

Key facts

Study ID

NCT03408951

Run by

NewPace Ltd

People needed

91

Starts

2017-03-02

Expected to finish

2018-12-05

Last updated by the study team

2019-08-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• candidate for ICD implantation
• candidate for an ICD DFT study
• candidate for an EP study

You may not qualify if…

• age <18

Where it is running

• St Francis Hospital Heart Center — Roslyn, New York, United States

Full record on ClinicalTrials.gov

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