Evaluation of the BodyGuardian End-to-end Remote Monitoring Platform in an Outpatient Heart Failure Population
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 13-005607
NCT ID: NCT01975402
Sponsor Protocol Number: 13-005607
About this study
We will evaluate the end to end remote monitoring system in a less controlled environment and concurrently develop the infrastructure to support the back end of the system
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Outpatients
- Stable NYHA Class I-III HF (defined as no admissions for > 1 year)
- Recruited from the Mayo Heart Failure Clinic, including 15 men and 15 women
- Age > 50 years
- Reside in Olmsted County
Exclusion Criteria:
- Hospital admission for HF within past year
- Dementia
- Overall life expectancy < 1 year
- Blindness
- Pregnancy or women able to become pregnant
- Skin allergy to adhesives
- Inadequate cell phone coverage (international patients or international travel during study period)
- Documented EF of >40%
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Lyle Olson, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available