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

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ClinicalTrials.gov Identifier: NCT03408951
Recruitment Status : Completed
First Posted : January 24, 2018
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
NewPace Ltd

Study Description
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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 tachyarrhythmia events and discrimination of supra-ventricular arrhythmia of the algorithm,m compared to the expert.

Condition or disease Intervention/treatment
Tachyarrhythmia Arrhythmias, Cardiac Other: Recording

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 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.
Study Design
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Study Type : Observational
Actual Enrollment : 91 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Surface ECG Signal Recording for the Implantable Subcutaneous String Defibrillator (ISSD) Detection Algorithm Performance Assessment
Actual Study Start Date : March 2, 2017
Actual Primary Completion Date : December 5, 2018
Actual Study Completion Date : December 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

Groups and Cohorts
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Group/Cohort Intervention/treatment
Interventions (recording)
Patients requiring Intracardiac defibrillator (ICD) implantation or Defibrillation Test (DFT) or Electrophysiology (EP) study with high probability of supra ventricular tachyarrhythmia.
 Other: Recording
The patient cutaneous ECG is recorded, to later be comparatively analysed by an expert and by the ISSD detection algorithm


Outcome Measures
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Primary Outcome Measures :
  1. ISSD algorithm detection rates [ Time Frame: through study completion, expected at 15 months ]
    Calculation of the ISSD algorithm detection and classification rates, compared to an EP expert analysis of the ECG traces


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with high chance of having a cardiac tachyarrhythmia
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • age <18
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03408951


Locations
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United States, New York
St Francis Hospital Heart Center
Roslyn, New York, United States, 11576
Sponsors and Collaborators
NewPace Ltd
Investigators
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Principal Investigator: Joseph H Levine, M.D St Francis Hospital Heart Center
Principal Investigator: David Hoch, M.D St Francis Hospital Heart Center
More Information
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Responsible Party: NewPace Ltd
ClinicalTrials.gov Identifier: NCT03408951    
Other Study ID Numbers: NPC03
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Tachycardia
Heart Diseases
 Cardiovascular Diseases
Pathologic Processes
Cardiac Conduction System Disease