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OpenTrials
Completed

NCT Number: NCT02991716

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

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.

Completed

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Key information

Conditions

Arrhythmia, Cardiac Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Study type

Observational

Primary location

JFK Medical Center

Atlantis, Florida, 33462, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • age<18

Treatment and study plan

recorded patients

Other

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

NewPace Ltd

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 13, 2016
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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