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

Cardiac Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02542163
• Other study ID #: IRB #9648
• Status: Completed
• Phase: N/A
• First received: August 28, 2015
• Last updated: March 25, 2016
• Start date: September 2015
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: NimbleHeart Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Rehabilitation

Locations

Country	Name	City	State
United States	Henry Ford Health System	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
NimbleHeart Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of difficulty in attaching the harness as compared to attaching the standard telemetry system.	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	3 to 4 months	No
Primary	Reported occurrences of subject discomfort	Percentage of subjects with reported harness discomfort and a description of each occurrence of discomfort	3 to 4 months	No