NCT01268007

Heartbeat Sensitivity Calibration Using the ECG Accessory

This is an Observational, Un-blinded, Non-significant Risk, Non-interventional Study Designed to Collect ECG Data on at Least One Subject Out of a Pool of up to Three (3) Healthy Male Subjects at One Clinical Site (Clinical Trials of Texas).

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1 (estimated)
• Sponsor: Cyberonics, Inc. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is an observational, un-blinded, non-significant risk, non-interventional study designed to collect ECG data on at least one subject out of a pool of up to three (3) healthy male subjects at one clinical site (Clinical Trials of Texas). Cyberonics will be collecting ECG recordings collected by an investigational device for comparison with conventional ECG recordings. This data will be used to validate a new device under development.

Detailed description

This is an observational, un-blinded, non-significant risk, non-interventional study designed to collect ECG data on at least one subject out of a pool of up to three (3) healthy male subjects at one clinical site (Clinical Trials of Texas). If acceptable data is acquired from one (1) subject the remaining subjects will not be entered into the study. Three (3) to six (6) researchers will record data, but all direct contact with the subject will be done by the study coordinator or principal investigator (PI). The purpose of this study is to validate a Heartbeat Sensitivity calibration process utilizing the Cyberonics ECG Accessory. The non-invasive, passive collection of ECG signals from a resting healthy subject will be used to validate the use of the ECG Accessory with the Model 201 Programming Wand, Model 250 VNS Programming Software Version 9.0, Model 106 Generator, and ECG monitor (DRE True ECG-12), as well as the associated Instructions for Use. The data generated from this exercise will be used in future clinical trials utilizing this device.

Conditions

• ECG Comparisons in Normal Healthy Subject

Timeline

• Start date: 2010-12-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-12-29
• Last updated: 2011-01-24

Locations

1 site across 1 country: United States