NCT02542163

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 4, 2016

Status Verified

March 1, 2016

Enrollment Period

2 months

First QC Date

August 28, 2015

Last Update Submit

March 31, 2016

Conditions

Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (3)

  • 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

  • Reported occurrences of subject discomfort

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

    3 to 4 months

  • Quality of ECG tracings during exercise

    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

    3 to 4 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cardiac Rehabilitation phase II population

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2015

First Posted

September 4, 2015

Study Start

September 1, 2015

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

April 4, 2016

Record last verified: 2016-03

Locations

US(1)