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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.

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
NameTimeMethod
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 discomfort3 to 4 months

Percentage of subjects with reported harness discomfort and a description of each occurrence of discomfort

Quality of ECG tracings during exercise3 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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Henry Ford Health System

🇺🇸

Detroit, Michigan, United States

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