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Surface Electrocardiogram (ECG) Signal Recording for Implantable Subcutaneous String Defibrillator (ISSD) Development

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ClinicalTrials.gov Identifier: NCT02991716
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
NewPace Ltd

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.

Condition or disease Intervention/treatment
Arrhythmia, Cardiac Other: recorded patients

Detailed Description:
2 electrodes places near the sternum and 2 near the midaxillary line, simulating the expected positions of Implantable Subcutaneous String Defibrillator (ISSD) sense electrodes. reference ECG electrodes are also attached (in most cases). Approved ECG recording devices are used to record the signal continuously: During an EP session (different types) a bedside recorder, and a holter monitor is used during holter recordings. Ep session recordings are performed in order to capture different types of arrhythmia, and holter recordings are performed to observe changes in ECG morphology due to activity, position changes, circadian cycles etc. The data is saved and used in the development of the ISSD.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Surface Electrocardiogram (ECG) Signal Recording for Implantable Subcutaneous String Defibrillator (ISSD) Development
Study Start Date : January 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

Group/Cohort Intervention/treatment
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
No intervention applied, only recording of cutaneous ECG signal from specific points on the torsi




Primary Outcome Measures :
  1. successful recording of Electrocardiogram (ECG) from a patient containing arrhythmia [ Time Frame: immediate ]
    recorded Electrocardiogram (ECG) of patients with as many arrhythmia events as possible, preferably tachy-arrhythmia events such as fast VT, flutter or VF



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • age<18

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): NCT02991716


Locations
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United States, Florida
JFK Medical Center
Atlantis, Florida, United States, 33462
Sponsors and Collaborators
NewPace Ltd
Investigators
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Principal Investigator: Vladimir Rankovic, M.D JFK Medical Center, Florida
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Responsible Party: NewPace Ltd
ClinicalTrials.gov Identifier: NCT02991716    
Other Study ID Numbers: NPC02
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes