AI-guided AF Treatment

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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

virtual assistant

Other

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 care

Other

AF care provided via the National Health System (NHS) standard AF care system

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Diana A Gorog, MD, PhD

CONTACT

[email protected]

01707247512

Sogol Koolaji, MD-MPH

CONTACT

[email protected]

+447394455974

Sponsors and collaborators

Lead sponsor

East and North Hertfordshire NHS Trust

Other Gov

Registry information

Official study title

Artificial Intelligent Guided Treatment of Atrial Fibrillation: A Randomized Controlled Pilot Study

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Jul 17, 2025
Registry last updated: Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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