Pilot Evaluation of the NimbleHeart Harness System in Cardiac Rehabilitation (PEN-CR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02542163|
Recruitment Status : Completed
First Posted : September 4, 2015
Last Update Posted : April 4, 2016
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
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|
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|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|
- 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
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|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|
- Participating in the Cardiac Rehabilitation Program.
- Capable of giving, and willing to sign, informed consent.
- Patients with either unstable heart disease or unstable heart failure and for whom exercise is contraindicated.
- Presence of Ventricular Assist Device (VAD).
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
|United States, Michigan|
|Henry Ford Health System|
|Detroit, Michigan, United States, 48202|
|Responsible Party:||NimbleHeart Inc.|
|Other Study ID Numbers:||
|First Posted:||September 4, 2015 Key Record Dates|
|Last Update Posted:||April 4, 2016|
|Last Verified:||March 2016|