Atrial FibrillationNCT06471764
Validation Study of Frontier X Plus (FX+) Device
An observational study of Atrial Fibrillation, run by Fourth Frontier Technologies Pvt Ltd..
Trial summary
The main objective of this study is to validate the specificity and sensitivity of FX+ detecting atrial fibrillation (AF) in both AF and non-AF subjects using a comparative approach, which involves using both a US FDA-cleared gold standard 12-lead and a consumer device which stores ECG (FX2 consumer model used to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- FX+ and 12-Lead ECG Recording
- Type of treatment
- Medical device
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 20 Apr 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will be a single center study conducted at the University of Rochester Medical Center between the Pulmonary Hypertension team and the Department of Cardiology. Patients who currently receive care by the Pulmonary Hypertension providers (Daniel Lachant, DO, R. James White, MD PhD, Dominic Roto, DO, and Kristine Ferrin, NP) or by a provider in the Department of Cardiology either outpatient or inpatient, will be recruited for study participation. We plan to enroll 125 subjects total (85 non-atrial fibrillation and 40 with atrial fibrillation). No participant will be excluded based on age, race, gender, or ethnic background and we will be sure to explain the subject matter and answer questions for all participants to their satisfaction. Pediatric participants \<18 years old will not be included as the device is indicated for use in those 18+. Non-English speaking adults will not be enrolled as we have seen less than 10 patients who do not speak English in our clinic.
Who may be able to join
- Age \>18 years Fluent in the English language
Who cannot join
- Acute or critical cardiac abnormality that may impair data collection as determined by the investigator Mechanical ventilation or any other kind of life support system Acute, serious, or life-threatening illness due to any cause (renal failure, liver failure, etc.) Pregnant or lactating individual Inability to tolerate FX+ device or 12-lead ECG placement.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Validation Study of Frontier X Plus (FX+) Device: Recording an Electrocardiogram (ECG) for Retrospective Rhythm Analysis in Patients with and Without Atrial Fibrillation (AF) in US Subjects
The main objective of this study is to validate the specificity and sensitivity of FX+ detecting atrial fibrillation (AF) in both AF and non-AF subjects using a comparative approach, which involves using both a US FDA-cleared gold standard 12-lead and a consumer device which stores ECG (FX2 consumer model used to store the ECG for analysis retrospectively).
The results obtained from this clinical investigation will serve as evidence for larger clinical investigation designs for this non-invasive and fully mobile method of continuous AF measurement in the adult population, including those with known or unknown cases of AF. The ultimate goal of this study is to establish the effectiveness of this novel approach in detecting and monitoring AF, which could potentially revolutionize the field of remote cardiac monitoring and improve the quality of care for patients with AF and other cardiac arrhythmias.
Read the detailed description
Atrial Fibrillation (AF) patients frequently require hospitalization, medications, and anticoagulation therapy, all of which can be costly. Moreover, living with and caring for AF patients can also be challenging, as the condition can cause physical, emotional, and financial stress for both patients and their caregivers. There are many published studies on non-invasive ECG monitoring devices and their benefits for patients with Atrial fibrillation. One study published in the Journal of the American College of Cardiology found that wearable ECG monitors can increase the detection of atrial fibrillation and potentially reduce the risk of stroke. Easy-to-use devices like FX+ with their ability to continuously record high-quality ECGs can aid monitoring without interrupting activities of daily living and can support more patient-involved self-management care that integrates education, engagement, and shared decision-making thereby allowing for a significant improvement in their quality of life, and a reduction in healthcare utilization.
There is an evolving belief that these wireless monitoring devices will mark a new era in medicine and a transition from population-level health care to individualized medicine in which suitable patients are equipped with advanced biosensors that, in turn, have their data processed through sophisticated algorithms to predict events before or leading to their occurrence.
The ECG is a measurement of the electrical activity of the heart. Each 20-second segment of the ECG data can be automatically analyzed for arrhythmia detection, which is classified into one of 6 categories: normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, inconclusive, unreadable.
The FX+ weighs ~20 grams and gets mounted on a chest strap embedded with ECG sensors. It has advanced miniaturized sensors, with onboard computing and wireless connectivity to enable the device to obtain and analyze ECG signals from the HeartKey ECG algorithm. FX+ helps create, record, store, transfer, and display a single-channel electrocardiogram (ECG) like a Lead-I ECG. The Frontier X Plus will determine the presence of atrial fibrillation (AF) and sinus rhythm on a classifiable waveform. Please note, for this study an FX2 (consumer non-medical version) with identical hardware will be utilized with modified firmware to collect data on the ECG rhythm status but not communicate it to the user or patient. For the purposes of the protocol the test device is referred to as the FX+.
FX+ is equipped with a Bluetooth Low Energy Transmitter which can communicate with a mobile application and control the data acquisition, displaying the status of the device, heart rate, and breathing rate. Optionally, the ECG waveform can be viewed in real-time on the mobile app during a live streaming session for assessing signal quality. The mobile App (Android and iOS) also stores the ECG and related information (arrhythmia) information and relays it to a cloud server for permanent storage and review by healthcare staff or investigators. The Frontier Plus Mobile application determines the presence of various types of rhythm on a classifiable waveform as indicated in the Table above. The device is for prescription use and the user is not intended to interpret or take clinical action based on the device output without consultation with a qualified healthcare professional. The ECG waveform will be intended to supplement rhythm classification to discriminate AF from sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment.
- Conditions
- Atrial Fibrillation
- Being tested
- FX+ and 12-Lead ECG Recording
- Keywords
- Validation, ECG, Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FX+ and 12-Lead ECG RecordingDevice
Also called Clinical Data Collection
While lying down, subjects will wear the FX+, a chest strap device which will measure cardiac electrical activity to generate a continuous heart rate measurement. Simultaneously, electrodes for the 12-Lead ECG will be placed on the chest and arms/legs to record the electrical activity. Two 30-second recordings from the FX+ will be taken simultaneously with the 12-lead ECG with no more than a 3-minute interval between the two recordings.
| Study group | Role | What they receive |
|---|---|---|
| FX+ and 12-Lead ECG Monitor Recording | Not described Receives: Device: FX+ and 12-Lead ECG Recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of reliability of Frontier X Plus (FX+) to produce a clinically equivalent waveform in agreement to a gold-standard 12-lead ECG's Lead-1 reference
- Validation of reliability of Frontier X Plus (FX+) to produce a clinically equivalent waveform in agreement to a gold-standard 12-lead ECG's Lead-1 reference by comparing: a. Quantitative review of RR intervals for date and time-matched segments b. Cardiologist naked-eye review and comparison of date and time-matched segments 2. Evaluate the Sensitivity and Specificity of the AF detection by Frontier X Plus (FX+) • Comparative 30-second rhythm analysis for AF detection obtained simultaneously from FX+ along with the 12-lead ECG (30-second recordings, repeated twice, consecutively)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion20 Jan 2025 (estimated)
- Study completion20 Apr 2025 (estimated)
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
- Other
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fourth Frontier Technologies Pvt Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471764
- Sponsor's protocol ID
- FF_DD_0104
- Status last verified
- Jun 2024
- First submitted
- 18 Jun 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study of Frontier X Plus (FX+) Device: Recording an Electrocardiogram (ECG) for Retrospective Rhythm Analysis in Patients with and Without Atrial Fibrillation (AF) in US Subjects
- ClinicalTrials.gov ID
- NCT06471764
- Acronym / sponsor ID
- FF_DD_0104
- Conditions
- Atrial Fibrillation
- Keywords
- Validation, ECG, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Fourth Frontier Technologies Pvt Ltd.Industry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 20 Jan 2025 (estimated)
- Study completion
- 20 Apr 2025 (estimated)
- First posted
- 24 Jun 2024 (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 main objective of this study is to validate the specificity and sensitivity of FX+ detecting atrial fibrillation (AF) in both AF and non-AF subjects using a comparative approach, which involves using both a US FDA-cleared gold standard 12-lead and a consumer device which stores ECG (FX2 consumer model used to store the ECG for analysis retrospectively).
The results obtained from this clinical investigation will serve as evidence for larger clinical investigation designs for this non-invasive and fully mobile method of continuous AF measurement in the adult population, including those with known or unknown cases of AF. The ultimate goal of this study is to establish the effectiveness of this novel approach in detecting and monitoring AF, which could potentially revolutionize the field of remote cardiac monitoring and improve the quality of care for patients with AF and other cardiac arrhythmias.
Detailed description
Atrial Fibrillation (AF) patients frequently require hospitalization, medications, and anticoagulation therapy, all of which can be costly. Moreover, living with and caring for AF patients can also be challenging, as the condition can cause physical, emotional, and financial stress for both patients and their caregivers. There are many published studies on non-invasive ECG monitoring devices and their benefits for patients with Atrial fibrillation. One study published in the Journal of the American College of Cardiology found that wearable ECG monitors can increase the detection of atrial fibrillation and potentially reduce the risk of stroke. Easy-to-use devices like FX+ with their ability to continuously record high-quality ECGs can aid monitoring without interrupting activities of daily living and can support more patient-involved self-management care that integrates education, engagement, and shared decision-making thereby allowing for a significant improvement in their quality of life, and a reduction in healthcare utilization.
There is an evolving belief that these wireless monitoring devices will mark a new era in medicine and a transition from population-level health care to individualized medicine in which suitable patients are equipped with advanced biosensors that, in turn, have their data processed through sophisticated algorithms to predict events before or leading to their occurrence.
The ECG is a measurement of the electrical activity of the heart. Each 20-second segment of the ECG data can be automatically analyzed for arrhythmia detection, which is classified into one of 6 categories: normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, inconclusive, unreadable.
The FX+ weighs ~20 grams and gets mounted on a chest strap embedded with ECG sensors. It has advanced miniaturized sensors, with onboard computing and wireless connectivity to enable the device to obtain and analyze ECG signals from the HeartKey ECG algorithm. FX+ helps create, record, store, transfer, and display a single-channel electrocardiogram (ECG) like a Lead-I ECG. The Frontier X Plus will determine the presence of atrial fibrillation (AF) and sinus rhythm on a classifiable waveform. Please note, for this study an FX2 (consumer non-medical version) with identical hardware will be utilized with modified firmware to collect data on the ECG rhythm status but not communicate it to the user or patient. For the purposes of the protocol the test device is referred to as the FX+.
FX+ is equipped with a Bluetooth Low Energy Transmitter which can communicate with a mobile application and control the data acquisition, displaying the status of the device, heart rate, and breathing rate. Optionally, the ECG waveform can be viewed in real-time on the mobile app during a live streaming session for assessing signal quality. The mobile App (Android and iOS) also stores the ECG and related information (arrhythmia) information and relays it to a cloud server for permanent storage and review by healthcare staff or investigators. The Frontier Plus Mobile application determines the presence of various types of rhythm on a classifiable waveform as indicated in the Table above. The device is for prescription use and the user is not intended to interpret or take clinical action based on the device output without consultation with a qualified healthcare professional. The ECG waveform will be intended to supplement rhythm classification to discriminate AF from sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FX+ and 12-Lead ECG Monitor Recording | – | Device: FX+ and 12-Lead ECG Recording |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be a single center study conducted at the University of Rochester Medical Center between the Pulmonary Hypertension team and the Department of Cardiology. Patients who currently receive care by the Pulmonary Hypertension providers (Daniel Lachant, DO, R. James White, MD PhD, Dominic Roto, DO, and Kristine Ferrin, NP) or by a provider in the Department of Cardiology either outpatient or inpatient, will be recruited for study participation. We plan to enroll 125 subjects total (85 non-atrial fibrillation and 40 with atrial fibrillation). No participant will be excluded based on age, race, gender, or ethnic background and we will be sure to explain the subject matter and answer questions for all participants to their satisfaction. Pediatric participants \<18 years old will not be included as the device is indicated for use in those 18+. Non-English speaking adults will not be enrolled as we have seen less than 10 patients who do not speak English in our clinic.
Key inclusion criteria (1 listed)
- Age \>18 years Fluent in the English language
Key exclusion criteria (1 listed)
- Acute or critical cardiac abnormality that may impair data collection as determined by the investigator Mechanical ventilation or any other kind of life support system Acute, serious, or life-threatening illness due to any cause (renal failure, liver failure, etc.) Pregnant or lactating individual Inability to tolerate FX+ device or 12-lead ECG placement.
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 |
|---|---|---|
| FX+ and 12-Lead ECG RecordingAlso: Clinical Data CollectionWhile lying down, subjects will wear the FX+, a chest strap device which will measure cardiac electrical activity to generate a continuous heart rate measurement. Simultaneously, electrodes for the 12-Lead ECG will be placed on the chest and arms/legs to record the electrical activity. Two 30-second recordings from the FX+ will be taken simultaneously with the 12-lead ECG with no more than a 3-minute interval between the two recordings. | Device | FX+ and 12-Lead ECG Monitor Recording |
Primary outcome
Validation of reliability of Frontier X Plus (FX+) to produce a clinically equivalent waveform in agreement to a gold-standard 12-lead ECG's Lead-1 reference
Time frame: 6 months
1. Validation of reliability of Frontier X Plus (FX+) to produce a clinically equivalent waveform in agreement to a gold-standard 12-lead ECG's Lead-1 reference by comparing: a. Quantitative review of RR intervals for date and time-matched segments b. Cardiologist naked-eye review and comparison of date and time-matched segments 2. Evaluate the Sensitivity and Specificity of the AF detection by Frontier X Plus (FX+) • Comparative 30-second rhythm analysis for AF detection obtained simultaneously from FX+ along with the 12-lead ECG (30-second recordings, repeated twice, consecutively)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Fourth Frontier Technologies Pvt Ltd..
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 1 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: status not confirmed, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Dr Lachant, MD (585-486-0147, daniel_lachant@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of reliability of Frontier X Plus (FX+) to produce a clinically equivalent waveform in agreement to a gold-standard 12-lead ECG's Lead-1 reference (time frame: 6 months). 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 24 Jun 2024.