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

Arrhythmia, Cardiac Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02991716
• Other study ID #: NPC02
• Status: Completed
• Phase: N/A
• First received: December 8, 2016
• Last updated: January 15, 2018
• Start date: January 2016
• Est. completion date: June 2017

Study information

• Verified date: January 2018
• Source: NewPace Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Candidate for ICD implantation

• Candidate for EP study

• Candidate for 24 hour holter monitor recording

Exclusion Criteria:

• age<18

Related Conditions & MeSH terms

• Arrhythmia, Cardiac
• Arrhythmias, Cardiac

Intervention

Other:
• recorded patients
No intervention applied, only recording of cutaneous ECG signal from specific points on the torsi

Locations

Country	Name	City	State
United States	JFK Medical Center	Atlantis	Florida

Sponsors (1)

Lead Sponsor	Collaborator
NewPace Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	successful recording of Electrocardiogram (ECG) from a patient containing arrhythmia	recorded Electrocardiogram (ECG) of patients with as many arrhythmia events as possible, preferably tachy-arrhythmia events such as fast VT, flutter or VF	immediate