Clinical Trials Logo
  1. Home
  2. Arrhythmia, Cardiac
  3. NCT02991716

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 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02991716
Study type Observational
Source NewPace Ltd
Contact
Status Completed
Phase N/A
Start date January 2016
Completion date June 2017
View Details
See also
  Status Clinical Trial Phase
Completed NCT05563701 - Evaluation of the LVivo Image Quality Scoring (IQS)
Completed NCT02585817 - Remote Patient Management for Cardiac Implantable Electronic Devices N/A
Recruiting NCT02988219 - Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method Phase 4
Suspended NCT03647891 - Impact of Early Diagnosis and Treatment of OSA on Hospital Readmission in Hospitalized Cardiac Patients N/A
Recruiting NCT04345627 - Japanese Lead Extraction Registry
Completed NCT04076020 - Atrial Fibrillation Health Literacy and Information Technology Trial in Rural Pennsylvania Counties N/A
Terminated NCT03035227 - Catheter Ablation of Arrhythmias to Improve CRT Response Phase 4
Completed NCT03150030 - Hypoglycaemia and Cardiac Arrhythmias in Type 2 Diabetes
Recruiting NCT05437926 - A Study to Describe the Effectiveness of Arrhythmia Analysis Software for Screening of Sinus Rhythm, Atrial Fibrillation and Premature Beats in light-and Dark Skin Tone Patients
Completed NCT01956487 - Bioequivalence of RYTHMOL SR® Manufactured at Two Different Sites Phase 1