AI-guided AF Treatment

NCT ID: NCT07069998

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2028-05-26

Brief 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) 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Standard of Care

Group Type: PLACEBO_COMPARATOR

Standard AF care

Intervention Type: OTHER

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

Virtual Assistant

Group Type: EXPERIMENTAL

virtual assistant

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Standard AF care

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

East and North Hertfordshire NHS Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Sogol Koolaji, MD-MPH

Role: CONTACT

sogol.koolaji@nhs.net

+447394455974

Diana A Gorog, MD, PhD

Role: CONTACT

d.gorog@imperial.ac.uk

01707247512

References

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.

Reference Type: BACKGROUND

PMID: 31944249 (View on PubMed)

Other Identifiers

RD2025-05

Identifier Type: -

Identifier Source: org_study_id