Arrhythmias, Cardiac Clinical Trial
— FRAILCIEDOfficial title:
Use of Device Data to Predict Frailty in Individuals With Cardiovascular Implantable Electrical Devices: Pilot Study
NCT number | NCT03079726 |
Other study ID # | 16-2587 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 7, 2017 |
Est. completion date | March 1, 2018 |
Verified date | October 2019 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is an investigation to examine the correlation and predictive ability of activity measures obtained from cardiovascular implantable electrical devices.
Status | Completed |
Enrollment | 50 |
Est. completion date | March 1, 2018 |
Est. primary completion date | March 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - Individuals followed in the UCH device clinic - Individuals with CIED implanted - Age over 65 Exclusion Criteria: - Unable/unwilling to provide informed consent |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado, Denver | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Daily Activity as measured with a Cardiovascular Implantable Electrical Device (CIED) | Daily activity adjudicated by CIED algorithm | 30 - 180 days | |
Primary | Presence of Cardiac arrhythmias | Any atrial or ventricular arrhythmia | From study onset until 2 years | |
Primary | Hospitalizations and Mortality | Any hospitalization or death | From study onset until 2 years |
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