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

Completed

• Conditions: Arrhythmia, Cardiac
• Interventions: Other: recorded patients

• Registration Number: NCT02991716
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-12-08
• Study First Submitted QC: 2016-12-09
• Study First Posted: 2016-12-13
• Primary Completion: 2017-04
• Study Completion: 2017-06
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-15
• Last Update Posted: 2018-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• age<18

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
successful recording of Electrocardiogram (ECG) from a patient containing arrhythmia	immediate	recorded Electrocardiogram (ECG) of patients with as many arrhythmia events as possible, preferably tachy-arrhythmia events such as fast VT, flutter or VF

Trial Locations

Locations (1)

JFK Medical Center; 🇺🇸 Atlantis, Florida, United States