Cardiac PatientsNCT02133261
BDx 7 Day ECG Patch: Electrode Adhesion Clinical Study
An observational study of Cardiac Patients and ECG Monitoring, run by Bardy Diagnostics, Inc. at 1 site in United States.
Trial summary
The purpose of this research study is to learn if a new 7 day patch ECG recording monitor can serve the same purpose as standard monitoring systems. The new 7day patch is significantly smaller and lighter than previous ECG recorders. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Patients, ECG Monitoring
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jun 2014
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: cardiac patients followed at the study site's location
Who may be able to join
- cardiac patient volunteers (5 male and 5 female)
Who cannot join
- skin rash or infection over the sternum
- Sternal incision within 3 months from the date of enrollment
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to learn if a new 7 day patch ECG recording monitor can serve the same purpose as standard monitoring systems. The new 7day patch is significantly smaller and lighter than previous ECG recorders.
Read the detailed description
The primary purpose of this research is to evaluate ECG signal quality of the BDx 7 day ECG Patch heart monitor after 7 full days of wear, establishing that the device is safe and effective to wear for up to 7 days.
- Conditions
- Cardiac Patients, ECG Monitoring
What is being measured
The primary outcome is the main question the study is designed to answer.
adhesive performance/durability
The study will evaluate adhesive performance/durability by evaluating the Signal Quality of ECG data on the subjects (5 men and 5 women) in accordance with the requirements of FDA's ECG Electrode Guidance (section 5.A.3)1 and the ANSI/AAMI EC-12 Disposable ECG electrode technical standard (sections 4.4 and 5.4)2.
Measured: 7 days
Secondary outcomes (1)
human factors
Skin comfort or discomfort Device comfort Device stability and contact
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac PatientsStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bardy Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gene Trobaugh, MD, Principal investigator, EvergreenHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133261
- Sponsor's protocol ID
- 7 day study
- Status last verified
- Jun 2014
- First submitted
- 6 May 2014
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BDx 7 Day ECG Patch: Electrode Adhesion Clinical Study
- ClinicalTrials.gov ID
- NCT02133261
- Acronym / sponsor ID
- 7 day study
- Conditions
- Cardiac Patients, ECG Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Bardy Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 May 2014 (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.
The purpose of this research study is to learn if a new 7 day patch ECG recording monitor can serve the same purpose as standard monitoring systems. The new 7day patch is significantly smaller and lighter than previous ECG recorders.
Detailed description
The primary purpose of this research is to evaluate ECG signal quality of the BDx 7 day ECG Patch heart monitor after 7 full days of wear, establishing that the device is safe and effective to wear for up to 7 days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cardiac patients followed at the study site's location
Key inclusion criteria (1 listed)
- cardiac patient volunteers (5 male and 5 female)
Key exclusion criteria (2 listed)
- skin rash or infection over the sternum
- Sternal incision within 3 months from the date of enrollment
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
adhesive performance/durability
Time frame: 7 days
The study will evaluate adhesive performance/durability by evaluating the Signal Quality of ECG data on the subjects (5 men and 5 women) in accordance with the requirements of FDA's ECG Electrode Guidance (section 5.A.3)1 and the ANSI/AAMI EC-12 Disposable ECG electrode technical standard (sections 4.4 and 5.4)2.
1 secondary outcome
human factors
Time frame: 7 days
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 26 Jun 2014.
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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.
Gene Trobaugh, MD principal investigator
EvergreenHealth
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 Patients and ECG Monitoring, run by Bardy Diagnostics, 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 1 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 26 Jun 2014. 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?
adhesive performance/durability (time frame: 7 days). 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 26 Jun 2014.