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

Completed

• Conditions: Cardiac Rehabilitation

• Registration Number: NCT02542163
• Lead Sponsor: NimbleHeart Inc.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-08-28
• Study Start: 2015-09
• Study First Submitted QC: 2015-09-02
• Study First Posted: 2015-09-04
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-31
• Last Update Posted: 2016-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States