Status:
COMPLETED
Surface ECG Signal Recording for the Implantable Subcutaneous String Defibrillator (ISSD) Detection Algorithm Performance Assessment
Lead Sponsor:
NewPace Ltd
Conditions:
Tachyarrhythmia
Arrhythmias, Cardiac
Eligibility:
All Genders
18+ years
Brief 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 tachyarrh...
Detailed 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 Thres...
Eligibility Criteria
Inclusion
- candidate for ICD implantation
- candidate for an ICD DFT study
- candidate for an EP study
Exclusion
- age \<18
Key Trial Info
Start Date :
March 2 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 5 2018
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT03408951
Start Date
March 2 2017
End Date
December 5 2018
Last Update
August 21 2019
Active Locations (1)
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1
St Francis Hospital Heart Center
Roslyn, New York, United States, 11576