Paroxysmal Atrial FibrillationNCT04563572
Determine AF Burden With PPG Trial - Detection and Quantification of Episodes of Atrial Fibrillation
A study testing PPG Smartwatch in people with Paroxysmal Atrial Fibrillation, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
In this prospective single-center trial, a wearable photoplethysmographic (PPG) sensor coupled with a cloud analytics service will be used to detect and quantify atrial fibrillation (AF) episodes in patients with known paroxysmal AF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- PPG Smartwatch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Oct 2020to 30 Jul 2022
- Phase
- Interventional
- 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
Who may be able to join
- Known paroxysmal atrial fibrillation
- Patient ≥ 18 years old
- Written informed consent as documented by signature from the patient
Who cannot join
- Cardiac implanted electronic device (Pacemaker, ICD)
- Smartwatch/Bracelet and/or ECG device cannot be worn due to comprehensible reasons (allergic reactions, wounds, amputations, other)
- Patients unable or not willing to sign informed consent Significant mental or cognitive impairment
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Universitiy Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: Determine AF Burden With PPG Trial - Detection and Quantification of Episodes of Atrial Fibrillation Using a Cloud Analytics Service Connected to a Wearable With Photoplethysmographic (PPG) Sensor
In this prospective single-center trial, a wearable photoplethysmographic (PPG) sensor coupled with a cloud analytics service will be used to detect and quantify atrial fibrillation (AF) episodes in patients with known paroxysmal AF. Patients will simultaneously receive the PPG sensor in form of a smartwatch or bracelet and a Holter ECG for 48 hours. Correctly identified AF episodes and AF burden determined by both methods will be compared.
Read the detailed description
Atrial fibrillation (AF) is the most common cardiac arrhythmia and a major risk factor for cerebrovascular insults. Paroxysmal AF is defined as an episode of AF that terminates spontaneously or with intervention within 7 days. Patients with AF may present with palpitations, shortness of breath or sensation of light-headedness but asymptomatic episodes are also possible, especially in paroxysmal AF. The lack of continuous heart rate monitoring options makes early diagnosis of paroxysmal AF challenging. In this prospective single-center trial, the PPG wearable Corsano CardioWatch 287 sensor will be used to conduct continuous heart rate and -rhythm monitoring in patients with known paroxysmal AF. Collected data will then be analysed using a Cloud Analytics Service (Preventicus Heartbeats algorithm) and compared with data from simultaneously obtained 48-hour Holter ECG. Correctly identified AF episodes, their cumulative duration per 48 hours (AF burden) and the number of asymptomatic episodes will be assessed. In the primary analyses, the sensitivity of the PPG analysing algorithm to detect AF episodes is estimated by performing a logistic regression on detection (yes/no) with only an intercept as predictor, which is then translated to a proportion (the sensitivity). In the secondary analyses we are comparing the cumulative duration of AF episodes over 48 hours (AF burden) obtained with the PPG-sensor and Holter-ECG. In summary, the purpose of the study is to evaluate the performance and efficacy of the wearable PPG sensor and the cloud analytics service in detecting and quantifying AF episodes in patients with known history of paroxysmal AF.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- PPG Smartwatch
- Keywords
- Wearables, AF Burden, Photoplethysmography (PPG), 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.
PPG SmartwatchDevice
Participants will then receive a PPG sensor in form of a smartwatch) model and will be instructed to wear them continuously for 48 hours. Simultaneously, a 48-hour Holter ECG will be performed. Start time on the PPG-sensor and the Holter ECG will be matched and continuous heart rhythm and -rate monitoring will be initiated. Patients will wear the devices over a 48-hour period of time.
| Study group | Role | What they receive |
|---|---|---|
| PPG Smartwatch | Experimental | The Preventicus Heartbeats algorithm ist a certified tool for detection of Atrial Fibrillation. It differentiates accurately between regular rhythm, single premature beats and the absolute arrhythmia concordant with AF. The Preventicus algorithm is device-agnostic, meaning that any wearable device capable of recording PPG-signals can be used for data collection.
CardioWatch 287 is a novel non-invasive monitoring device manufactured by the MMT company. The device monitors heart rhythm, heart rate (HR) and respiratory rate (RR) based on peripheral PPG signal.
In this arm, we will test the quality of the algorithm integrated into the smartwatch. Receives: Device: PPG Smartwatch |
| PPG Bracelet | Experimental | The Preventicus Heartbeats algorithm ist a certified tool for detection of Atrial Fibrillation. It differentiates accurately between regular rhythm, single premature beats and the absolute arrhythmia concordant with AF. The Preventicus algorithm is device-agnostic, meaning that any wearable device capable of recording PPG-signals can be used for data collection.
A PPG-sensor is also integrated into a bracelet "Basler Band" manufactured by the MMT company, which is a simplified multisensory device.
In this arm, we will test the quality of the algorithm integrated into the bracelet. Receives: Device: PPG Smartwatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of AF episodes
Number of detected atrial fibrillation episodes by the PPG sensor and Preventicus Heartbeats algorithm during the 48h trial period compared to the Holter ECG.
Measured: 48 hours
Secondary outcomes (2)
AF Burden
Cumulative duration of AF episodes
Measured: 48 hours
Asymptomatic AF episodes
Number of asymptomatic AF episodes
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start13 Oct 2020
- Primary completion28 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paroxysmal 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will receive a PPG sensor in form of a smartwatch or a bracelet and will be instructed to wear them continuously for 48 hours. Assigning patients to the smartwatch or the bracelet group will occur in an alternating fashion.
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Preventicus GmbH, Manufacture Modules Technologies SA, GETEMED GmbH, Eurostars
- Responsible party
- Sponsor
- Investigators
- Jens Eckstein, MD, PhD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563572
- Sponsor's protocol ID
- 2020-01983
- Status last verified
- Nov 2022
- First submitted
- 18 Sep 2020
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reissenberger P, Serfozo P, Piper D, Juchler N, Glanzmann S, Gram J, Hensler K, Tonidandel H, Borlin E, D'Souza M, Badertscher P, Eckstein J. Determine atrial fibrillation burden with a photoplethysmographic mobile sensor: the atrial fibrillation burden trial: detection and quantification of episodes of atrial fibrillation using a cloud analytics service connected to a wearable with photoplethysmographic sensor. Eur Heart J Digit Health. 2023 Jul 6;4(5):402-410. doi: 10.1093/ehjdh/ztad039. eCollection 2023 Oct.
PubMed 37794868
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determine AF Burden With PPG Trial - Detection and Quantification of Episodes of Atrial Fibrillation Using a Cloud Analytics Service Connected to a Wearable With Photoplethysmographic (PPG) Sensor
- ClinicalTrials.gov ID
- NCT04563572
- Acronym / sponsor ID
- 2020-01983
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Wearables, AF Burden, Photoplethysmography (PPG), Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Preventicus GmbH, Manufacture Modules Technologies SA, GETEMED GmbH, Eurostars
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 28 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 24 Sep 2020 (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.
In this prospective single-center trial, a wearable photoplethysmographic (PPG) sensor coupled with a cloud analytics service will be used to detect and quantify atrial fibrillation (AF) episodes in patients with known paroxysmal AF. Patients will simultaneously receive the PPG sensor in form of a smartwatch or bracelet and a Holter ECG for 48 hours. Correctly identified AF episodes and AF burden determined by both methods will be compared.
Detailed description
Atrial fibrillation (AF) is the most common cardiac arrhythmia and a major risk factor for cerebrovascular insults. Paroxysmal AF is defined as an episode of AF that terminates spontaneously or with intervention within 7 days. Patients with AF may present with palpitations, shortness of breath or sensation of light-headedness but asymptomatic episodes are also possible, especially in paroxysmal AF. The lack of continuous heart rate monitoring options makes early diagnosis of paroxysmal AF challenging. In this prospective single-center trial, the PPG wearable Corsano CardioWatch 287 sensor will be used to conduct continuous heart rate and -rhythm monitoring in patients with known paroxysmal AF. Collected data will then be analysed using a Cloud Analytics Service (Preventicus Heartbeats algorithm) and compared with data from simultaneously obtained 48-hour Holter ECG. Correctly identified AF episodes, their cumulative duration per 48 hours (AF burden) and the number of asymptomatic episodes will be assessed. In the primary analyses, the sensitivity of the PPG analysing algorithm to detect AF episodes is estimated by performing a logistic regression on detection (yes/no) with only an intercept as predictor, which is then translated to a proportion (the sensitivity). In the secondary analyses we are comparing the cumulative duration of AF episodes over 48 hours (AF burden) obtained with the PPG-sensor and Holter-ECG. In summary, the purpose of the study is to evaluate the performance and efficacy of the wearable PPG sensor and the cloud analytics service in detecting and quantifying AF episodes in patients with known history of paroxysmal AF.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will receive a PPG sensor in form of a smartwatch or a bracelet and will be instructed to wear them continuously for 48 hours. Assigning patients to the smartwatch or the bracelet group will occur in an alternating fashion.
| Arm | Type | Receives |
|---|---|---|
| PPG Smartwatch | Experimental | Device: PPG SmartwatchThe Preventicus Heartbeats algorithm ist a certified tool for detection of Atrial Fibrillation. It differentiates accurately between regular rhythm, single premature beats and the absolute arrhythmia concordant with AF. The Preventicus algorithm is device-agnostic, meaning that any wearable device capable of recording PPG-signals can be used for data collection. CardioWatch 287 is a novel non-invasive monitoring device manufactured by the MMT company. The device monitors heart rhythm, heart rate (HR) and respiratory rate (RR) based on peripheral PPG signal. In this arm, we will test the quality of the algorithm integrated into the smartwatch. |
| PPG Bracelet | Experimental | Device: PPG SmartwatchThe Preventicus Heartbeats algorithm ist a certified tool for detection of Atrial Fibrillation. It differentiates accurately between regular rhythm, single premature beats and the absolute arrhythmia concordant with AF. The Preventicus algorithm is device-agnostic, meaning that any wearable device capable of recording PPG-signals can be used for data collection. A PPG-sensor is also integrated into a bracelet "Basler Band" manufactured by the MMT company, which is a simplified multisensory device. In this arm, we will test the quality of the algorithm integrated into the bracelet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Known paroxysmal atrial fibrillation
- Patient ≥ 18 years old
- Written informed consent as documented by signature from the patient
Key exclusion criteria (3 listed)
- Cardiac implanted electronic device (Pacemaker, ICD)
- Smartwatch/Bracelet and/or ECG device cannot be worn due to comprehensible reasons (allergic reactions, wounds, amputations, other)
- Patients unable or not willing to sign informed consent Significant mental or cognitive impairment
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 |
|---|---|---|
| PPG SmartwatchParticipants will then receive a PPG sensor in form of a smartwatch) model and will be instructed to wear them continuously for 48 hours. Simultaneously, a 48-hour Holter ECG will be performed. Start time on the PPG-sensor and the Holter ECG will be matched and continuous heart rhythm and -rate monitoring will be initiated. Patients will wear the devices over a 48-hour period of time. | Device | PPG Bracelet, PPG Smartwatch |
Primary outcome
Number of AF episodes
Time frame: 48 hours
Number of detected atrial fibrillation episodes by the PPG sensor and Preventicus Heartbeats algorithm during the 48h trial period compared to the Holter ECG.
2 secondary outcomes
AF Burden
Time frame: 48 hours
Asymptomatic AF episodes
Time frame: 48 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 15 Nov 2022.
- Derived from this study: PubMed 37794868Reissenberger P, Serfozo P, Piper D, Juchler N, Glanzmann S, Gram J, Hensler K, Tonidandel H, Borlin E, D'Souza M, Badertscher P, Eckstein J. Determine atrial fibrillation burden with a photoplethysmographic mobile sensor: the atrial fibrillation burden trial: detection and quantification of episodes of atrial fibrillation using a cloud analytics service connected to a wearable with photoplethysmographic sensor. Eur Heart J Digit Health. 2023 Jul 6;4(5):402-410. doi: 10.1093/ehjdh/ztad039. eCollection 2023 Oct.
- 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.
Jens Eckstein, MD, PhD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PPG Smartwatch in people with Paroxysmal Atrial Fibrillation, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 3 inclusion and 3 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 15 Nov 2022. 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 Switzerland. 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?
Number of AF episodes (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04563572, which also lists 1 linked publication.
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 15 Nov 2022; AzTrials last refreshed its copy on 30 Oct 2026.