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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Arrhythmia, Cardiac

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Recorded patients

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