NCT02991716

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: NewPace Ltd · Industry
• Sex: —
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Arrhythmia, Cardiac

Interventions

Type	Name	Description
OTHER	recorded patients	No intervention applied, only recording of cutaneous ECG signal from specific points on the torsi

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-04-01
• Completion: 2017-06-01
• First posted: 2016-12-13
• Last updated: 2018-01-17

Locations

1 site across 1 country: United States