AI-guided AF Treatment

East and North Hertfordshire NHS Trust

Status: Not yet enrolling

Conditions: Atrial Fibrillation (AF)

Treatments: Other: virtual assistant; Other: Standard AF care

Study type: Interventional

Funder types: Other

Identifiers

NCT07069998

RD2025-05

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years
2. Documented diagnosis of AF within the last 6 months
3. 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
4. Ability to understand and comprehend the study rationale, design, and process.

Exclusion criteria

1. Severe comorbidities (such as physical impairment, cognitive impairment, and hearing loss) that could affect protocol adherence, in the opinion of the investigator
2. Chronic Kidney Disease (CKD) stage 4-5 or on dialysis
3. Medical illness with a life expectancy of less than 1 year
4. Alternative potentially reversible causes of AF (such as surgery, sepsis, or thyroid dysfunction)
5. Dementia or other cognitive impairment
6. Currently involved in another AF interventional clinical trial
7. Being pregnant

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

Standard of Care

Placebo Comparator group

Treatment:

Other: Standard AF care

Virtual Assistant

Experimental group

Treatment:

Other: virtual assistant