Atrial FibrillationNCT02162394
A Study to Determine the Feasibility of Wireless Electrocardiography
An observational study of Atrial Fibrillation and Premature Atrial and Ventricular Beats, run by Peerbridge Health, Inc at 1 site in United States.
Trial summary
The investigators are conducting a prospective, observational study to examine the ECG waveforms captured by the new medical device as compared to a traditional Holter monitor for subsequent use in visual diagnoses of atrial and ventricular arrhythmias as well as cardiac impulse and/or conduction disorders by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Premature Atrial and Ventricular Beats, Conduction Defects
- What is being tested?
- Observational ambulatory ECG monitoring
- Type of treatment
- Medical device
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jan 2016
- 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: Subjects referred for 24 hour Holter monitoring
Who may be able to join
- Patients must be at least 18 years of age
- Patients must have a medical indication to wear a Holter monitor
- Patients must not be pregnant
- Patients must be able to comply with the study procedures
- Patients must be willing to participate and able to provide informed consent
- Patients must be willing to wear both devices (Holter and the wireless device prototype) simultaneously and continuously for a 2 to 3 hr period
Who cannot join
- Patients who are not able or willing to comply with study procedures
- Patients with an existing implanted cardioverter-defibrillator and/or pacemaker
- Patients with a known life threatening arrhythmia
- Patients who manifest low voltage on their electrocardiogram
- Patients affected by inflammatory and/or infectious skin disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Determine the Feasibility of Wireless Electrocardiography
The investigators are conducting a prospective, observational study to examine the ECG waveforms captured by the new medical device as compared to a traditional Holter monitor for subsequent use in visual diagnoses of atrial and ventricular arrhythmias as well as cardiac impulse and/or conduction disorders by qualified clinicians.
The hypothesis is that this new medical device prototype is non-inferior to traditional Holter monitoring for capturing ECG waveforms that can be visually assessed for atrial and ventricular arrhythmias as well as disorders of cardiac impulse formation and/or conduction.
- Conditions
- Atrial Fibrillation, Premature Atrial and Ventricular Beats, Conduction Defects, Normal Sinus Rhythm
- Being tested
- Observational ambulatory ECG monitoring
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational ambulatory ECG monitoringDevice
| Study group | Role | What they receive |
|---|---|---|
| Referred for Holter monitoring | Not described Receives: Device: Observational ambulatory ECG monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of 8 second ECG strips of sufficient quality for visual diagnosis
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionApr 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peerbridge Health, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162394
- Sponsor's protocol ID
- 14-022A
- Status last verified
- Sep 2017
- First submitted
- 10 Jun 2014
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Determine the Feasibility of Wireless Electrocardiography
- ClinicalTrials.gov ID
- NCT02162394
- Acronym / sponsor ID
- 14-022A
- Conditions
- Atrial Fibrillation, Premature Atrial and Ventricular Beats, Conduction Defects, Normal Sinus Rhythm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Peerbridge Health, IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 12 Jun 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 investigators are conducting a prospective, observational study to examine the ECG waveforms captured by the new medical device as compared to a traditional Holter monitor for subsequent use in visual diagnoses of atrial and ventricular arrhythmias as well as cardiac impulse and/or conduction disorders by qualified clinicians.
The hypothesis is that this new medical device prototype is non-inferior to traditional Holter monitoring for capturing ECG waveforms that can be visually assessed for atrial and ventricular arrhythmias as well as disorders of cardiac impulse formation and/or conduction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Referred for Holter monitoring | – | Device: Observational ambulatory ECG monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects referred for 24 hour Holter monitoring
Key inclusion criteria (6 listed)
- Patients must be at least 18 years of age
- Patients must have a medical indication to wear a Holter monitor
- Patients must not be pregnant
- Patients must be able to comply with the study procedures
- Patients must be willing to participate and able to provide informed consent
Key exclusion criteria (5 listed)
- Patients who are not able or willing to comply with study procedures
- Patients with an existing implanted cardioverter-defibrillator and/or pacemaker
- Patients with a known life threatening arrhythmia
- Patients who manifest low voltage on their electrocardiogram
- Patients affected by inflammatory and/or infectious skin disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational ambulatory ECG monitoring | Device | Referred for Holter monitoring |
Primary outcome
Percent of 8 second ECG strips of sufficient quality for visual diagnosis
Time frame: 3 hours
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 25 Sep 2017.
- Individual participant dataSharing planned: No
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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 Atrial Fibrillation and Premature Atrial and Ventricular Beats, run by Peerbridge Health, 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 6 inclusion and 5 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 25 Sep 2017. 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?
Percent of 8 second ECG strips of sufficient quality for visual diagnosis (time frame: 3 hours). 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 25 Sep 2017; AzTrials last refreshed its copy on 6 Nov 2026.