Arrhythmias, Cardiac Clinical Trial
Official title:
Surface ECG Signal Recording for the Implantable Subcutaneous String Defibrillator (ISSD) Detection Algorithm Performance Assessment
NCT number | NCT03408951 |
Other study ID # | NPC03 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2, 2017 |
Est. completion date | December 5, 2018 |
Verified date | January 2018 |
Source | NewPace Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | St Francis Hospital Heart Center | Roslyn | New York |
Lead Sponsor | Collaborator |
---|---|
NewPace Ltd |
United States,
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 |
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