Atrial FibrillationSLAF-BPNCT03813446
Detection of Heart Rhythm and BP With RhythmPadBP
An observational study of Atrial Fibrillation, run by Cardiocity Limited at 1 site in United Kingdom.
Trial summary
This study will assess a new device, the RhythmPadBP, which detects heart rhythm and measure blood pressure simply by placing palms of the hands on a pad containing titanium electrodes. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Device: RhythmPadBP
- Type of treatment
- Medical device
- How many people
- 1,100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Apr 2017to 31 Mar 2019
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients attending for routine 12-lead ECG, referred by the primary care physician and also patients attending cardiology department at Ashford \& St Peters Hospitals NHS Foundation Trust, Chertsey
Who may be able to join
- Age greater or equal to 18 years
- Able to consent
- No known allergies to the metal or any component used in the RhythmPadBP
Who cannot join
- Age less than 18 years
- Not able to consent
- Allergies to the metal or any component of the RhythmPadBP device
- Active skin conditions affecting the hands, i.e. burns, infections
- In-situ cardiac devices i.e. pacemaker or a defibrillator that could interfere with the ECG recording.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Ashford and St Peters NHS Trust
Chertsey, Surrey, KT16 0PZ
About this study
Official title: A Study to Evaluate the Effectiveness of a Novel Device, the RhythmPadBP, in Accurately Detecting Heart Rhythm and Recording Blood Pressure Simultaneously
This study will assess a new device, the RhythmPadBP, which detects heart rhythm and measure blood pressure simply by placing palms of the hands on a pad containing titanium electrodes.
Read the detailed description
Normally the way a doctor will assess the rhythm of the heart involves asking for an electrocardiogram (ECG) which involves having to remove clothing, and sometimes shaving hair. 10 different leads are attached to stickers that are placed on the chest, and other parts of the body. This is known as a 12-lead ECG and is the standard way that heart-rhythm problems are first investigated. The usual method of measuring blood pressure (BP) involves wrapping a cuff around the arm and inflating it to enough to measure the BP. The reading is then displayed on a monitor. This can sometimes be uncomfortable and is often time consuming, particularly in busy clinical settings.
Recent advances in technology however have given us different ways of gaining some of the same information given by a 12 lead ECG and the standard BP apparatus, using much easier to use devices. One of these devices is the RhythmPadBP system by Cardiocity TM. This is a device where participants can record the underlying heart rhythm and BP readings simply by placing palms of both hands on the device. This device does not require removal of clothing or placing a BP cuff around arm and so the readings can be gained more rapidly and with greater convenience.
Investigators propose to test this device to assess how accurately it recognises the most common cardiac rhythm disturbances, e.g. atrial fibrillation (AF), and also measures the blood pressure. This will help to identify AF and any difference of BP in both arms.
AF is an independent risk factor for stroke and increases the risk of stroke by five-fold. A discrepancy of BP in both arms can be a sign of blood vessel disease and is linked to increased risk of cardiovascular and cerebrovascular disease. If investigators find that this device is correctly recording AF and BP, it may give us another simpler way of diagnosing AF and BP discrepancies on both sides.
- Conditions
- Atrial Fibrillation
- Being tested
- Device: RhythmPadBP
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: RhythmPadBPDevice
Detection of heart rhythm and measurement of blood pressure
Intervention:
Patients will start by wearing a consumer SmartWatch (Huwaei SmartWatch 2, which has a CE mark) and a 60 second reading of their wrist Photoplethysmyograph (PPG) will be recorded. This will enable us to compare the PPG from the wrist with the fingertip data collected from the RhythmPadBP.
The watch will be cleaned with alcohol wipe in the same manner that the RhythmPadBP is cleaned between subjects use.
Patients will be asked to place their palms of both hands on RhythmPadBP and then the underlying heart rhythm and BP will be recorded. 12-lead ECG and BP reading will be obtained by standard devices for comparison.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of Atrial Fibrillation
The diagnosis of Atrial Fibrillation will be achieved through Cardiologist review of p-waves and QRS complexes on both a 1 lead and a 12 lead ECG conducted at the time of study for each participant.
Measured: 18 months
Secondary outcomes (1)
Measurement of BP in both arms with standard BP apparatus Vs RhythmPad BP recordings
Measurement of blood pressure simultaneously from both arms comparing the two procedures. Both systolic and diastolic blood pressure will be recorded.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start17 Apr 2017
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
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
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiocity Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Riyaz A Kaba, MBBS, FRCP, Principal investigator, Ashford and St Peter's Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813446
- Sponsor's protocol ID
- 2016RAK01
- Acronym
- SLAF-BP
- Status last verified
- Aug 2019
- First submitted
- 16 Jan 2017
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effectiveness of a Novel Device, the RhythmPadBP, in Accurately Detecting Heart Rhythm and Recording Blood Pressure Simultaneously
- ClinicalTrials.gov ID
- NCT03813446
- Acronym / sponsor ID
- SLAF-BP / 2016RAK01
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Cardiocity LimitedIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2017 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 23 Jan 2019 (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.
This study will assess a new device, the RhythmPadBP, which detects heart rhythm and measure blood pressure simply by placing palms of the hands on a pad containing titanium electrodes.
Detailed description
Normally the way a doctor will assess the rhythm of the heart involves asking for an electrocardiogram (ECG) which involves having to remove clothing, and sometimes shaving hair. 10 different leads are attached to stickers that are placed on the chest, and other parts of the body. This is known as a 12-lead ECG and is the standard way that heart-rhythm problems are first investigated. The usual method of measuring blood pressure (BP) involves wrapping a cuff around the arm and inflating it to enough to measure the BP. The reading is then displayed on a monitor. This can sometimes be uncomfortable and is often time consuming, particularly in busy clinical settings.
Recent advances in technology however have given us different ways of gaining some of the same information given by a 12 lead ECG and the standard BP apparatus, using much easier to use devices. One of these devices is the RhythmPadBP system by Cardiocity TM. This is a device where participants can record the underlying heart rhythm and BP readings simply by placing palms of both hands on the device. This device does not require removal of clothing or placing a BP cuff around arm and so the readings can be gained more rapidly and with greater convenience.
Investigators propose to test this device to assess how accurately it recognises the most common cardiac rhythm disturbances, e.g. atrial fibrillation (AF), and also measures the blood pressure. This will help to identify AF and any difference of BP in both arms.
AF is an independent risk factor for stroke and increases the risk of stroke by five-fold. A discrepancy of BP in both arms can be a sign of blood vessel disease and is linked to increased risk of cardiovascular and cerebrovascular disease. If investigators find that this device is correctly recording AF and BP, it may give us another simpler way of diagnosing AF and BP discrepancies on both sides.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending for routine 12-lead ECG, referred by the primary care physician and also patients attending cardiology department at Ashford \& St Peters Hospitals NHS Foundation Trust, Chertsey
Key inclusion criteria (3 listed)
- Age greater or equal to 18 years
- Able to consent
- No known allergies to the metal or any component used in the RhythmPadBP
Key exclusion criteria (5 listed)
- Age less than 18 years
- Not able to consent
- Allergies to the metal or any component of the RhythmPadBP device
- Active skin conditions affecting the hands, i.e. burns, infections
- In-situ cardiac devices i.e. pacemaker or a defibrillator that could interfere with the ECG recording.
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 |
|---|---|---|
| Device: RhythmPadBPDetection of heart rhythm and measurement of blood pressure Intervention: Patients will start by wearing a consumer SmartWatch (Huwaei SmartWatch 2, which has a CE mark) and a 60 second reading of their wrist Photoplethysmyograph (PPG) will be recorded. This will enable us to compare the PPG from the wrist with the fingertip data collected from the RhythmPadBP. The watch will be cleaned with alcohol wipe in the same manner that the RhythmPadBP is cleaned between subjects use. Patients will be asked to place their palms of both hands on RhythmPadBP and then the underlying heart rhythm and BP will be recorded. 12-lead ECG and BP reading will be obtained by standard devices for comparison. | Device | – |
Primary outcome
Diagnosis of Atrial Fibrillation
Time frame: 18 months
The diagnosis of Atrial Fibrillation will be achieved through Cardiologist review of p-waves and QRS complexes on both a 1 lead and a 12 lead ECG conducted at the time of study for each participant.
1 secondary outcome
Measurement of BP in both arms with standard BP apparatus Vs RhythmPad BP recordings
Time frame: 18 months
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 6 Aug 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Riyaz A Kaba, MBBS, FRCP principal investigator
Ashford and St Peter's Hospitals NHS Foundation Trust
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, run by Cardiocity Limited at 1 site in United Kingdom.
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 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 6 Aug 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 Kingdom. 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?
Diagnosis of Atrial Fibrillation (time frame: 18 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 6 Aug 2019.