Arrythmia, CardiacNCT03711695
iBeat Wristwatch Validation Study
An observational study of Arrythmia, Cardiac, run by University of California, San Francisco at 1 site in United States.
Trial summary
The iBeat Study is a single-center, prospective, unblinded validation of the photoplethysmography (PPG) and tissue oximetry (TO) signal waveforms recorded from a wrist-based sensor devices. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Arrythmia, Cardiac
- What is being tested?
- iBeat wristwatch device
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2018to 30 Dec 2018
- 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 21 to 85 years
- All sexes
- Adult, Older adult
Study population: The study population will consist of adults that present for either catheter ablation, cardiac device interrogation, or defibrillation threshold testing.
Who may be able to join
- Age ≥ 21 years and ≤ 85 years
- Able to understand and give informed consent.
- Subject is presenting for the following planned procedures:
- 3.1 Group A (25 subjects): Subjects presenting for catheter ablation for cardiac arrhythmias (e.g. atrial fibrillation, supraventricular tachycardia, or ventricular tachycardia) 3.2 Group B (25 subjects): Subjects judged based on the clinical evaluation of high, greater than 75%, atrial pacing or ventricular pacing burden or known pacing dependence with planned device interrogation for: 1) pacemaker (single or dual chamber), 2) implantable cardioverter-defibrillator (single or dual chamber), or 3) cardiac resynchronization therapy with or without defibrillator (single or dual chamber plus left ventricular pacing).
- 3.3 Group C (5 subjects): Subjects for clinically indicated defibrillation threshold testing (DFT) (with a transvenous or subcutaneous ICD lead system)
Who cannot join
- Age < 21 years and > 85 years
- Unable to or refuse to give written informed consent
- Unwilling or unable to wear the smartwatch device on at least one wrist
- Uncorrected severe aortic stenosis or subaortic stenosis (including hypertrophic cardiomyopathy) with outflow tract obstruction > 50 mm
- New York Heart Association Class IV Heart Failure
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Validation of Signal Waveforms in a Consumer-based Wristwatch Prototype Device During Standard Cardiac Procedures
The iBeat Study is a single-center, prospective, unblinded validation of the photoplethysmography (PPG) and tissue oximetry (TO) signal waveforms recorded from a wrist-based sensor devices.
Read the detailed description
The goal of the proposed research is to validate PPG and TO signal waveforms recorded from a wist-based sensor device, which is worn on one or both arms, during catheter ablation, device interrogation, and defibrillation threshold testing (DFT). It is a non-invasive procedure that will include placing a wrist-based sensor on subjects who consent participate. Data collected from routine clinical care devices used during these procedures (catheter ablations, device interrogations, and DFTs) will confirm data collected from the iBeat wristwatch.
- Conditions
- Arrythmia, Cardiac
- Being tested
- iBeat wristwatch device
- Keywords
- ibeat, wrist watch, digital health, Arrythmia
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iBeat wristwatch deviceDevice
The participant will be asked to wear one iBeat wristwatch device on each arm during the planned procedure.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Subjects presenting for catheter ablation for cardiac arrhythmias (e.g. atrial fibrillation, supraventricular tachycardia, or ventricular tachycardia) Receives: Device: iBeat wristwatch device | |
| Group B | Subjects judged based on the clinical evaluation of high, greater than 75%, atrial pacing or ventricular pacing burden or known pacing dependence with planned device interrogation for: 1) pacemaker (single or dual chamber), 2) implantable cardioverter-defibrillator (single or dual chamber), or 3) cardiac resynchronization therapy with or without defibrillator (single or dual chamber plus left ventricular pacing). Receives: Device: iBeat wristwatch device | |
| Group C | Subjects for clinically indicated defibrillation threshold testing (DFT) (with a transvenous or subcutaneous implantable cardioverter defibrillator (ICD) lead system) Receives: Device: iBeat wristwatch device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect hemodynamic significant (e.g. Ventricular tachycardia, ventircular fibrillatio, supra ventricular tachycardia with fast ventricular rate, etc) arrhythmias using photoplethysmography
Detect hemodynamic significant arrhythmia using changes in photoplethysmography [PPG] as measured using a wrist-watch.
Measured: Immediate
Detect hemodynamic significant (e.g. Ventricular tachycardia, ventircular fibrillatio, supra ventricular tachycardia with fast ventricular rate, etc) arrhythmias using tissue oxygenation
Detect hemodynamic significant arrhythmia using changes in tissue oxygenation as measured using a wrist-watch.
Measured: Immediate
Secondary outcomes (2)
Detect benign arrhythmia (e.g. sinus tachycardia, atrial flutter, atrial fibrillation supra-ventricular tachycardia) using changes in photoplethysmography
Detect hemodynamic significant arrhythmia by using changes in photoplethysmography signal, as measured using a wrist-watch.
Measured: Immediate
Detect benign arrhythmia (e.g. sinus tachycardia, atrial flutter, atrial fibrillation supra-ventricular tachycardia) using changes in tissue oxygenation
Detect hemodynamic significant arrhythmia by using changes in tissue oxygenation signal, as measured using a wrist-watch.
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start22 Mar 2018
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrythmia, CardiacStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- iBeat Inc.
- Responsible party
- Sponsor
- Investigators
- Jeffrey Olgin, MD, Principal investigator, University of California, San FranciscoRobert Avram, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711695
- Sponsor's protocol ID
- 17-23761
- Status last verified
- Mar 2019
- First submitted
- 27 Feb 2018
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The patient data will not be shared with other researchers. However, study outcomes will be published in peer-reviewed journals.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Signal Waveforms in a Consumer-based Wristwatch Prototype Device During Standard Cardiac Procedures
- ClinicalTrials.gov ID
- NCT03711695
- Acronym / sponsor ID
- 17-23761
- Conditions
- Arrythmia, Cardiac
- Keywords
- ibeat, wrist watch, digital health, Arrythmia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- iBeat Inc.
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 18 Oct 2018 (actual)
- 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 iBeat Study is a single-center, prospective, unblinded validation of the photoplethysmography (PPG) and tissue oximetry (TO) signal waveforms recorded from a wrist-based sensor devices.
Detailed description
The goal of the proposed research is to validate PPG and TO signal waveforms recorded from a wist-based sensor device, which is worn on one or both arms, during catheter ablation, device interrogation, and defibrillation threshold testing (DFT). It is a non-invasive procedure that will include placing a wrist-based sensor on subjects who consent participate. Data collected from routine clinical care devices used during these procedures (catheter ablations, device interrogations, and DFTs) will confirm data collected from the iBeat wristwatch.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Device: iBeat wristwatch deviceSubjects presenting for catheter ablation for cardiac arrhythmias (e.g. atrial fibrillation, supraventricular tachycardia, or ventricular tachycardia) |
| Group B | – | Device: iBeat wristwatch deviceSubjects judged based on the clinical evaluation of high, greater than 75%, atrial pacing or ventricular pacing burden or known pacing dependence with planned device interrogation for: 1) pacemaker (single or dual chamber), 2) implantable cardioverter-defibrillator (single or dual chamber), or 3) cardiac resynchronization therapy with or without defibrillator (single or dual chamber plus left ventricular pacing). |
| Group C | – | Device: iBeat wristwatch deviceSubjects for clinically indicated defibrillation threshold testing (DFT) (with a transvenous or subcutaneous implantable cardioverter defibrillator (ICD) lead system) |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adults that present for either catheter ablation, cardiac device interrogation, or defibrillation threshold testing.
Key inclusion criteria (5 listed)
- Age ≥ 21 years and ≤ 85 years
- Able to understand and give informed consent.
- Subject is presenting for the following planned procedures:
- 3.1 Group A (25 subjects): Subjects presenting for catheter ablation for cardiac arrhythmias (e.g. atrial fibrillation, supraventricular tachycardia, or ventricular tachycardia) 3.2 Group B (25 subjects): Subjects judged based on the clinical evaluation of high, greater than 75%, atrial pacing or ventricular pacing burden or known pacing dependence with planned device interrogation for: 1) pacemaker (single or dual chamber), 2) implantable cardioverter-defibrillator (single or dual chamber), or 3) cardiac resynchronization therapy with or without defibrillator (single or dual chamber plus left ventricular pacing).
- 3.3 Group C (5 subjects): Subjects for clinically indicated defibrillation threshold testing (DFT) (with a transvenous or subcutaneous ICD lead system)
Key exclusion criteria (5 listed)
- Age < 21 years and > 85 years
- Unable to or refuse to give written informed consent
- Unwilling or unable to wear the smartwatch device on at least one wrist
- Uncorrected severe aortic stenosis or subaortic stenosis (including hypertrophic cardiomyopathy) with outflow tract obstruction > 50 mm
- New York Heart Association Class IV Heart Failure
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 |
|---|---|---|
| iBeat wristwatch deviceThe participant will be asked to wear one iBeat wristwatch device on each arm during the planned procedure. | Device | Group A, Group B, Group C |
Primary outcome
Detect hemodynamic significant (e.g. Ventricular tachycardia, ventircular fibrillatio, supra ventricular tachycardia with fast ventricular rate, etc) arrhythmias using photoplethysmography
Time frame: Immediate
Detect hemodynamic significant arrhythmia using changes in photoplethysmography [PPG] as measured using a wrist-watch.
Detect hemodynamic significant (e.g. Ventricular tachycardia, ventircular fibrillatio, supra ventricular tachycardia with fast ventricular rate, etc) arrhythmias using tissue oxygenation
Time frame: Immediate
Detect hemodynamic significant arrhythmia using changes in tissue oxygenation as measured using a wrist-watch.
2 secondary outcomes
Detect benign arrhythmia (e.g. sinus tachycardia, atrial flutter, atrial fibrillation supra-ventricular tachycardia) using changes in photoplethysmography
Time frame: Immediate
Detect benign arrhythmia (e.g. sinus tachycardia, atrial flutter, atrial fibrillation supra-ventricular tachycardia) using changes in tissue oxygenation
Time frame: Immediate
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 5 Mar 2019.
- Individual participant dataSharing planned: No. The patient data will not be shared with other researchers. However, study outcomes will be published in peer-reviewed journals.
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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.
Jeffrey Olgin, MD principal investigator
University of California, San Francisco
Robert Avram, MD principal investigator
University of California, San Francisco
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 Arrythmia, Cardiac, run by University of California, San Francisco 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 5 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 5 Mar 2019. 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?
Detect hemodynamic significant (e.g. Ventricular tachycardia, ventircular fibrillatio, supra ventricular tachycardia with fast ventricular rate, etc) arrhythmias using photoplethysmography (time frame: Immediate). The study lists 2 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 5 Mar 2019.