Cardiac RehabilitationNCT02542163
Pilot Evaluation of the NimbleHeart Harness System in Cardiac Rehabilitation (PEN-CR)
An observational study of Cardiac Rehabilitation, run by NimbleHeart Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Rehabilitation
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiac Rehabilitation phase II population
Who may be able to join
- Participating in the Cardiac Rehabilitation Program.
- Capable of giving, and willing to sign, informed consent.
Who cannot join
- Patients with either unstable heart disease or unstable heart failure and for whom exercise is contraindicated.
- Presence of Ventricular Assist Device (VAD).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cardiac Rehabilitation
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 to 4 months
Reported occurrences of subject discomfort
Percentage of subjects with reported harness discomfort and a description of each occurrence of discomfort
Measured: 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
Measured: 3 to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- NimbleHeart Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542163
- Sponsor's protocol ID
- IRB #9648
- Status last verified
- Mar 2016
- First submitted
- 28 Aug 2015
- Last updated
- 4 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of the NimbleHeart Harness System in Cardiac Rehabilitation (PEN-CR)
- ClinicalTrials.gov ID
- NCT02542163
- Acronym / sponsor ID
- IRB #9648
- Conditions
- Cardiac Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- NimbleHeart Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac Rehabilitation phase II population
Key inclusion criteria (2 listed)
- Participating in the Cardiac Rehabilitation Program.
- Capable of giving, and willing to sign, informed consent.
Key exclusion criteria (2 listed)
- Patients with either unstable heart disease or unstable heart failure and for whom exercise is contraindicated.
- Presence of Ventricular Assist Device (VAD).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Rehabilitation, run by NimbleHeart Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of difficulty in attaching the harness as compared to attaching the standard telemetry system. (time frame: 3 to 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2016.