NCT03408951

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2018

Completed
Last Updated

August 21, 2019

Status Verified

January 1, 2018

Enrollment Period

1.8 years

First QC Date

January 16, 2018

Last Update Submit

August 20, 2019

Conditions

TachyarrhythmiaArrhythmias, Cardiac

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

RecordingOTHER

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

Interventions (recording)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with high chance of having a cardiac tachyarrhythmia

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Francis Hospital Heart Center

Roslyn, New York, 11576, United States

Location

MeSH Terms

Conditions

TachycardiaArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Joseph H Levine, M.D

    St Francis Hospital Heart Center

    PRINCIPAL INVESTIGATOR

  • David Hoch, M.D

    St Francis Hospital Heart Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2018

First Posted

January 24, 2018

Study Start

March 2, 2017

Primary Completion

December 5, 2018

Study Completion

December 5, 2018

Last Updated

August 21, 2019

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)