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

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ClinicalTrials.gov Identifier: NCT02542163
Recruitment Status : Completed
First Posted : September 4, 2015
Last Update Posted : April 4, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Cardiac Rehabilitation

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 Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Evaluation of the NimbleHeart Harness System in Cardiac Rehabilitation (PEN-CR)
Study Start Date : September 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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


  2. 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

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cardiac Rehabilitation phase II population
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02542163


Locations
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
NimbleHeart Inc.

Responsible Party: NimbleHeart Inc.
ClinicalTrials.gov Identifier: NCT02542163     History of Changes
Other Study ID Numbers: IRB #9648
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: April 4, 2016
Last Verified: March 2016