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

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.

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Key information

Conditions

Cardiac Rehabilitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Henry Ford Health System

Detroit, Michigan, 48202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participating in the Cardiac Rehabilitation Program.
Capable of giving, and willing to sign, informed consent.

Exclusion criteria

Patients with either unstable heart disease or unstable heart failure and for whom exercise is contraindicated.
Presence of Ventricular Assist Device (VAD).

Treatment and study plan

Primary outcomes

Degree of difficulty in attaching the harness as compared to attaching the standard telemetry system.

Time frame: 3 to 4 months

How "easy" or "difficult" it is to apply the harness system as compared to existing telemetry system.

Scores range from 1 to 5 scale where 1 = More difficult and 5 = Much easier
Reported occurrences of subject discomfort

Time frame: 3 to 4 months

Percentage of subjects with reported harness discomfort and a description of each occurrence of discomfort
Quality of ECG tracings during exercise

Time frame: 3 to 4 months

Degree of ECG quality to determine heart rate and detect arrhythmia during subject exercise Scores range from 1 to 3 scale where 1 = Poor and 3 = Good

Sponsors and collaborators

Lead sponsor

NimbleHeart Inc.

Industry

Registry information

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Sep 4, 2015
Registry last updated: Apr 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed