Atrial Fibrillation (AF)NCT07069998
AI-guided AF Treatment
A study testing virtual assistant and Standard AF care in people with Atrial Fibrillation (AF), run by East and North Hertfordshire NHS Trust.
Trial summary
Two-centre, prospective, randomized, open-label, controlled pilot study to examine whether integrating an artificial intelligence virtual assistant (VA), instructed with the latest international guidelines on optimal patient management into the outpatient management of patients diagnosed with atrial fibrillation (AF)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- virtual assistant and Standard AF care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2025to 26 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years
- Documented diagnosis of AF within the last 6 months
- Patient is at least mildly symptomatic. Presence of at least one of the symptoms like palpitation, dizziness, breathlessness, pre-syncope, and syncope with at least mild intensity
- Ability to understand and comprehend the study rationale, design, and process.
Who cannot join
- Severe comorbidities (such as physical impairment, cognitive impairment, and hearing loss) that could affect protocol adherence, in the opinion of the investigator
- Chronic Kidney Disease (CKD) stage 4-5 or on dialysis
- Medical illness with a life expectancy of less than 1 year
- Alternative potentially reversible causes of AF (such as surgery, sepsis, or thyroid dysfunction)
- Dementia or other cognitive impairment
- Currently involved in another AF interventional clinical trial
- Being pregnant
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Artificial Intelligent Guided Treatment of Atrial Fibrillation: A Randomized Controlled Pilot Study
Two-centre, prospective, randomized, open-label, controlled pilot study to examine whether integrating an artificial intelligence virtual assistant (VA), instructed with the latest international guidelines on optimal patient management into the outpatient management of patients diagnosed with atrial fibrillation (AF) in the last 6 months, is feasible, acceptable and effective in reducing the need for regular medical assessment and the healthcare burden, reduce variability, and meets with participant satisfaction, without compromising participant safety and overall care quality.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- virtual assistant, Standard AF care
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual assistantOther
Programming codes that interpret atrial fibrillation symptoms and design management plans based on algorithms that reflect the European Society of Cardiology (ESC) 2024 guidelines and the expertise of consultant cardiologists, finally checked and approved by a cardiologist.
Standard AF careOther
AF care provided via the National Health System (NHS) standard AF care system
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Placebo comparator | Not described Receives: Other: Standard AF care |
| Virtual Assistant | Experimental | Not described Receives: Other: virtual assistant |
What is being measured
The primary outcome is the main question the study is designed to answer.
How acceptable is the Virtual Assistant (VA) system as assessed by Sekhon's Theoretical Framework of Acceptability (TFA) questionnaire.
The acceptability of the Virtual Assistant (VA) system will be assessed using an acceptability questionnaire adapted from the 2022 Sekhon et al. Theoretical Framework of Acceptability (TFA). The questionnaire will be completed separately by both patients and research administrators, with the resulting scores reflecting the overall acceptability of the intervention.
The questionnaire employs Likert-type scales and includes the following TFA components, where the highest score shows greater acceptability in that component:
Affective Attitude: 2 items (scored 0-10, where 0 = lowest acceptability and 10 = highest) Burden: 2 items (scored 0-10) Ethicality: 1 item (scored 0-5) Perceived Effectiveness: 1 item (scored 0-7) Intervention Coherence: 1 item (scored 0-5) Self-Efficacy: 2 items (scored 0-10) General Acceptability: 1 item (scored 0-5)
Measured: 12 weeks
Patient-Reported Adherence to the Virtual Assistant (VA) System: 4-Item Feasibility Questionnaire
Adherence to the VA system, as a marker of feasibility, will be assessed using a 4-item questionnaire adapted from the study by An, M. et al. ("What really works in intervention? Using fidelity measures to support optimal outcomes." Physical Therapy, 100(5), pp. 757-765). This questionnaire will be completed by patients and is designed to evaluate key aspects of adherence.
Each item is scored on a 4-point scale (0-3), with a total possible score of 12. Higher scores indicate greater adherence to the VA system.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start15 Jul 2025 (estimated)
- Primary completion26 May 2028 (estimated)
- Study completion26 May 2028 (estimated)
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 Atrial Fibrillation (AF)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East and North Hertfordshire NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069998
- Sponsor's protocol ID
- RD2025-05
- Status last verified
- Jul 2025
- First submitted
- 21 May 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
An M, Dusing SC, Harbourne RT, Sheridan SM; START-Play Consortium. What Really Works in Intervention? Using Fidelity Measures to Support Optimal Outcomes. Phys Ther. 2020 May 18;100(5):757-765. doi: 10.1093/ptj/pzaa006.
PubMed 31944249
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligent Guided Treatment of Atrial Fibrillation: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT07069998
- Acronym / sponsor ID
- RD2025-05
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- East and North Hertfordshire NHS TrustOther government
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 26 May 2028 (estimated)
- Study completion
- 26 May 2028 (estimated)
- First posted
- 17 Jul 2025 (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.
Two-centre, prospective, randomized, open-label, controlled pilot study to examine whether integrating an artificial intelligence virtual assistant (VA), instructed with the latest international guidelines on optimal patient management into the outpatient management of patients diagnosed with atrial fibrillation (AF) in the last 6 months, is feasible, acceptable and effective in reducing the need for regular medical assessment and the healthcare burden, reduce variability, and meets with participant satisfaction, without compromising participant safety and overall care quality.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Placebo comparator | Other: Standard AF care |
| Virtual Assistant | Experimental | Other: virtual assistant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Documented diagnosis of AF within the last 6 months
- Patient is at least mildly symptomatic. Presence of at least one of the symptoms like palpitation, dizziness, breathlessness, pre-syncope, and syncope with at least mild intensity
- Ability to understand and comprehend the study rationale, design, and process.
Key exclusion criteria (7 listed)
- Severe comorbidities (such as physical impairment, cognitive impairment, and hearing loss) that could affect protocol adherence, in the opinion of the investigator
- Chronic Kidney Disease (CKD) stage 4-5 or on dialysis
- Medical illness with a life expectancy of less than 1 year
- Alternative potentially reversible causes of AF (such as surgery, sepsis, or thyroid dysfunction)
- Dementia or other 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 |
|---|---|---|
| virtual assistantProgramming codes that interpret atrial fibrillation symptoms and design management plans based on algorithms that reflect the European Society of Cardiology (ESC) 2024 guidelines and the expertise of consultant cardiologists, finally checked and approved by a cardiologist. | Other | Virtual Assistant |
| Standard AF careAF care provided via the National Health System (NHS) standard AF care system | Other | Standard of Care |
Primary outcome
How acceptable is the Virtual Assistant (VA) system as assessed by Sekhon's Theoretical Framework of Acceptability (TFA) questionnaire.
Time frame: 12 weeks
The acceptability of the Virtual Assistant (VA) system will be assessed using an acceptability questionnaire adapted from the 2022 Sekhon et al. Theoretical Framework of Acceptability (TFA). The questionnaire will be completed separately by both patients and research administrators, with the resulting scores reflecting the overall acceptability of the intervention. The questionnaire employs Likert-type scales and includes the following TFA components, where the highest score shows greater acceptability in that component: Affective Attitude: 2 items (scored 0-10, where 0 = lowest acceptability and 10 = highest) Burden: 2 items (scored 0-10) Ethicality: 1 item (scored 0-5) Perceived Effectiveness: 1 item (scored 0-7) Intervention Coherence: 1 item (scored 0-5) Self-Efficacy: 2 items (scored 0-10) General Acceptability: 1 item (scored 0-5)
Patient-Reported Adherence to the Virtual Assistant (VA) System: 4-Item Feasibility Questionnaire
Time frame: 12 weeks
Adherence to the VA system, as a marker of feasibility, will be assessed using a 4-item questionnaire adapted from the study by An, M. et al. ("What really works in intervention? Using fidelity measures to support optimal outcomes." Physical Therapy, 100(5), pp. 757-765). This questionnaire will be completed by patients and is designed to evaluate key aspects of adherence. Each item is scored on a 4-point scale (0-3), with a total possible score of 12. Higher scores indicate greater adherence to the VA system.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Background: PubMed 31944249An M, Dusing SC, Harbourne RT, Sheridan SM; START-Play Consortium. What Really Works in Intervention? Using Fidelity Measures to Support Optimal Outcomes. Phys Ther. 2020 May 18;100(5):757-765. doi: 10.1093/ptj/pzaa006.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation (AF)
RecruitingObservational study
BOdygUardian MOnitoriNg for ReCurrencE of AF
Atrial Fibrillation (AF)
Active, not recruitingObservational study
Resumption of Anticoagulation After Major Gastrointestinal Bleeding in Patients With Atrial Fibrillation
Atrial Fibrillation (AF), Gastrointestinal Bleeding
Recruiting
A Comparison of Pulsed Field Ablation (PFA) vs Cryoablation for Atrial Fibrillation Under Deep Sedation
Atrial Fibrillation (AF)
Not yet recruiting
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
Atrial Fibrillation (AF)
RecruitingObservational study
PULSED AF Post-Approval Study
Atrial Fibrillation
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.
Questions about this trial
What is this clinical trial studying?
A study testing virtual assistant and Standard AF care in people with Atrial Fibrillation (AF), run by East and North Hertfordshire NHS Trust.
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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 17 Jul 2025. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sogol Koolaji, MD-MPH (+447394455974, sogol.koolaji@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
How acceptable is the Virtual Assistant (VA) system as assessed by Sekhon's Theoretical Framework of Acceptability (TFA) questionnaire. (time frame: 12 weeks). 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?
On the ClinicalTrials.gov record for NCT07069998, 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 17 Jul 2025.