Heartbeat Sensitivity Calibration Using the ECG Accessory

This study has been completed.
Sponsor:
Information provided by:
Cyberonics, Inc.
ClinicalTrials.gov Identifier:
NCT01268007
First received: December 28, 2010
Last updated: January 20, 2011
Last verified: December 2010
  Purpose

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.


Condition
ECG Comparisons in Normal Healthy Subject

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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).

Further study details as provided by Cyberonics, Inc.:

Primary Outcome Measures:
  • Comparison of ECG measurements [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    No specific effectiveness outcomes or calculations are planned for this non-interventional study. The sponsor will use the ECG data collected during this study as a comparison of the subject's actual ECG waveforms obtained through standard ECG connections to the ECG Accessory transmitted heart beat detection signals from the Model 106 Generator to the ECG monitor.


Estimated Enrollment: 1
Study Start Date: December 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal ECG measurements
Observational, un-blinded, non-interventional study designed to collect ECG data on at least one (1) male patient in an outpatient setting.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Normal Healthy male

Criteria

Inclusion Criteria:

  • 1. Patients must be 18 years or older, male, and of any race.
  • 2. Patient must be in good general health, fully ambulatory, and able to complete the physical aspects of testing requirements.
  • 3. Patient must be willing and able to complete informed consent and HIPAA authorization.

Exclusion Criteria:

  • 1. Subjects with skin abnormalities or conditions that would interfere with ECG electrode patch placement or cause subject discomfort with patch placement.
  • 2. Subjects report history of allergies or sensitivity to adhesive tapes or patches.
  • 3. Subjects with major health condition that in the investigator's judgment would prevent the subject's successful completion of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01268007

Locations
United States, Texas
Clinical Trials of Texas
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Cyberonics, Inc.
  More Information

No publications provided

Responsible Party: Dr. Douglas Denham, DO, Clinical Trials of Texas
ClinicalTrials.gov Identifier: NCT01268007     History of Changes
Other Study ID Numbers: E-46
Study First Received: December 28, 2010
Last Updated: January 20, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 24, 2014