AI-guided AF Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: virtual assistant, Standard AF care.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Artificial Intelligent Guided Treatment of Atrial Fibrillation: A Randomized Controlled Pilot Study
Overview
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.
Interventions
- Other virtual assistant
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. - Other Standard AF care
AF care provided via the National Health System (NHS) standard AF care system
Primary outcome measures
- How acceptable is the Virtual Assistant (VA) system as assessed by Sekhon's Theoretical Framework of Acceptability (TFA) questionnaire. [Time frame: 12 weeks]
- Patient-Reported Adherence to the Virtual Assistant (VA) System: 4-Item Feasibility Questionnaire [Time frame: 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
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. PMID 31944249
Identifiers
NCT: NCT07069998 · RD2025-05