Pilot Evaluation of the NimbleHeart Harness System in Cardiac Rehabilitation (PEN-CR)

NimbleHeart

Status: Completed

Conditions: Cardiac Rehabilitation

Study type: Observational

Funder types: Industry

Identifiers

NCT02542163

IRB #9648

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).