Pilot Evaluation of the NimbleHeart Harness System in Cardiac Rehabilitation (PEN-CR)
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2015 |
| End Date: | December 2015 |
Purpose: To conduct a pilot study to assess the feasibility of the NimbleHeart wireless
telemetry vest in cardiac rehabilitation.
Study Design: This is a prospective, single center, non-randomized, pilot trial evaluating
the NimbleHeart chest harness system.
telemetry vest in cardiac rehabilitation.
Study Design: This is a prospective, single center, non-randomized, pilot trial evaluating
the NimbleHeart chest harness system.
20 subjects will be consented to participate at an early cardiac rehabilitation exercise
session (typically sessions 1-6). Subjects will wear the NimbleHeart vest concurrently with
existing telemetry system during exercise sessions, and thus not replace existing telemetry
monitoring. Both staff and subjects will be queried for their (user) experiences during and
after each session. Experiences will be documented on surveys after each session.
De-identified ECG rhythm strips from the NimbleHeart monitor will be collected to assess
quality of tracings. Subjects will be asked to wear the NimbleHeart vest for 2 sessions.
Study participation will end after the 2nd session.
session (typically sessions 1-6). Subjects will wear the NimbleHeart vest concurrently with
existing telemetry system during exercise sessions, and thus not replace existing telemetry
monitoring. Both staff and subjects will be queried for their (user) experiences during and
after each session. Experiences will be documented on surveys after each session.
De-identified ECG rhythm strips from the NimbleHeart monitor will be collected to assess
quality of tracings. Subjects will be asked to wear the NimbleHeart vest for 2 sessions.
Study participation will end after the 2nd session.
Inclusion Criteria:
1. Participating in the Cardiac Rehabilitation Program.
2. Capable of giving, and willing to sign, informed consent.
Exclusion Criteria:
1. Patients with either unstable heart disease or unstable heart failure and for whom
exercise is contraindicated.
2. Presence of Ventricular Assist Device (VAD).
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