NCT02991716

Brief Summary

Record cutaneous Electrocardiogram (ECG) data from positions corresponding to the expected subcutaneous locations of the Implantable Subcutaneous String Defibrillator (ISSD) using existing, approved ECG recording devices.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

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

January 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

1.2 years

First QC Date

December 8, 2016

Last Update Submit

January 15, 2018

Conditions

Arrhythmia, Cardiac

Outcome Measures

Primary Outcomes (1)

  • successful recording of Electrocardiogram (ECG) from a patient containing arrhythmia

    recorded Electrocardiogram (ECG) of patients with as many arrhythmia events as possible, preferably tachy-arrhythmia events such as fast VT, flutter or VF

    immediate

Study Arms (1)

Recorded patients

Patients requiring Intracradiac Defibrillator (ICD) implantation, Electrophysiology (EP) study or a holter monitor recording, mainly due to suspected ventricular tachy - arrhythmias

Other: recorded patients

Interventions

recorded patientsOTHER

No intervention applied, only recording of cutaneous ECG signal from specific points on the torsi

Recorded patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients requiring Intracradiac Defibrillator (ICD) implantation, Electrophysiology (EP) study or a holter monitor recording, mainly due to suspected ventricular tachy - arrhythmias

You may qualify if:

  • Candidate for ICD implantation
  • Candidate for EP study
  • Candidate for 24 hour holter monitor recording

You may not qualify if:

  • age\<18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

JFK Medical Center

Atlantis, Florida, 33462, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vladimir Rankovic, M.D

    JFK Medical Center, Florida

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 8, 2016

First Posted

December 13, 2016

Study Start

January 1, 2016

Primary Completion

April 1, 2017

Study Completion

June 1, 2017

Last Updated

January 17, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)