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

Arrhythmias, Cardiac Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03408951
• Other study ID #: NPC03
• Status: Completed
• Start date: March 2, 2017
• Est. completion date: December 5, 2018

Study information

• Verified date: January 2018
• Source: NewPace Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

cutaneous ECG electrodes positioned near the sternum and on the midaxillary line, at the approximate positions of the ISSD sense electrodes, are used to record patients undergoing Defibrillation Threshold (DFT) studies or Electrophysiology (EP) studies of different types. Two separate copies of the recordings undergo parallel and separate analysis: one is sent to an expert Electrophysiologist for determination and classification of arrhythmia events of at least 5 seconds and at least 170 beats per minute. the other is fed to the ISSD detection algorithm, with a low cutoff rate of 170 beats per minute. the results are compared to establish the accuracy of the detection algorithm and the rate of false detection / classification of arrhythmia events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: December 5, 2018
• Est. primary completion date: December 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• candidate for ICD implantation

• candidate for an ICD DFT study

• candidate for an EP study

Exclusion Criteria:

• age <18

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Tachyarrhythmia
• Tachycardia

Intervention

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

Locations

Country	Name	City	State
United States	St Francis Hospital Heart Center	Roslyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
NewPace Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ISSD algorithm detection rates	Calculation of the ISSD algorithm detection and classification rates, compared to an EP expert analysis of the ECG traces	through study completion, expected at 15 months