A Study to Evaluate Smart Clothing for the Detection of Cardiac Electrical Activity and Arrhythmias
Overview
Tab Title Description
Study type
ObservationalDescribes 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: 18-009018
Sponsor Protocol Number: 18-009018
About this study
The purpose of this study is to examine the fidelity of the electrical signal produced from non-adhesive textile electrodes in a chestband based form factor, to compare signals obtained between the chestband based form factor and the clinical 12 lead ECG recording done on the same day, and to assess the performance of an atrial fibrillation detection algorithm on the signals obtained pre-cardioversion (in atrial fibrillation) and post-cardioversion (in sinus rhythm) from the novel smart-clothing form factor and the routine 12-lead ECG.
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:
- Patients undergoing cardioversion for atrial fibrillation (in either the inpatient or outpatient setting).
- BMI < 40.
- 18 years of age or more.
- Willing to give informed consent.
Exclusion Criteria:
- Patients with known allergy to silver.
- Patients with any cardiac device (pacemaker, ICD).
- Patients with recent trauma to the chest wall or chest deformity precluding placement of the shirt.
- Pregnant or lactating woman.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available