NCT06600620

Brief Summary

Atrial Fibrillation (AF) is the commonest arrhythmia worldwide, affects 5% of people over the age of 65 and increases the risk of stroke and heart failure. The investigators aim to detect clinical and subclinical episodes of atrial fibrillation lasting \>30 seconds to develop risk prediction models to identify patients at high risk for ischaemic stroke.

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
27mo left

Started Sep 2024

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Sep 2024Aug 2028

First Submitted

Initial submission to the registry

September 12, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

September 23, 2024

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2028

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

September 15, 2025

Status Verified

June 1, 2025

Enrollment Period

3.9 years

First QC Date

September 12, 2024

Last Update Submit

September 8, 2025

Conditions

Keywords

atrial fibrillation

Outcome Measures

Primary Outcomes (2)

  • To determine the incidence of clinical and subclinical episodes of AF in acutely unwell patients and to generate data for the development and validation of virtual twins and clinical decision support tools.

    1\) Number of participants with device detected AF lasting greater than 30 seconds

    48 months

  • To determine the incidence of clinical and subclinical episodes of AF in acutely unwell patients and to generate data for the development and validation of virtual twins and clinical decision support tools.

    Number of episodes of AF and duration of each AF episode

    48 months

Secondary Outcomes (18)

  • Length of hospital stay

    48 months

  • Hospital readmissions within 90 days

    48 months

  • Recurrence of AF episodes

    48 months

  • Hospital and 90-day Mortality

    48 months

  • Time spent in AF

    48 months

  • +13 more secondary outcomes

Study Arms (7)

Patients admitted or referred to Critical Care (NOTE-AF ICU)

Patients admitted or referred to Critical Care

Device: Monitoring patients heart rythms with a wireless patch device

Patients admitted to hospital with acute heart failure (NOTE-AF HF)

Patients admitted to hospital with acute heart failure

Device: Monitoring patients heart rythms with a wireless patch device

Patients admitted to Emergency Services with sepsis or infection (NOTE-AF Sepsis)

Patients admitted to Emergency Services with sepsis or infection

Device: Monitoring patients heart rythms with a wireless patch device

Patients post upper gastrointestinal surgery (NOTE-AF PULSE-GI)

Patients post upper gastrointestinal surgery

Device: Monitoring patients heart rythms with a wireless patch device

Patients post vascular interventions (NOTE-AF Vasc)

Patients post vascular interventions

Device: Monitoring patients heart rythms with a wireless patch device

Patients with acute respiratory failure (NOTE-AF Resp)

Patients with acute respiratory failure

Device: Monitoring patients heart rythms with a wireless patch device

Patients admitted after acute stroke (NOTE-AF stroke)

Patients admitted after acute stroke

Device: Monitoring patients heart rythms with a wireless patch device

Interventions

The investigators will collect data in patients at high risk of atrial fibrillation (AF) without a known history of AF to determine clinical predicators of AF. This data will be used to generate virtual digital twins to to predict clinical and subclinical episodes of AF

Patients admitted after acute stroke (NOTE-AF stroke)Patients admitted or referred to Critical Care (NOTE-AF ICU)Patients admitted to Emergency Services with sepsis or infection (NOTE-AF Sepsis)Patients admitted to hospital with acute heart failure (NOTE-AF HF)Patients post upper gastrointestinal surgery (NOTE-AF PULSE-GI)Patients post vascular interventions (NOTE-AF Vasc)Patients with acute respiratory failure (NOTE-AF Resp)

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to hospital with a variety of medical conditions

You may qualify if:

  • Adult patients ≥50 years
  • Estimated risk of developing new episodes of AF greater than 5%
  • Sinus rhythm at presentation
  • One of the following acute conditions:
  • Patients admitted or referred to Critical Care (NOTE-AF ICU)
  • Patients admitted to hospital with acute heart failure (NOTE-AF HF)
  • Patients admitted to Emergency Services with sepsis or infection (NOTE-AF Sepsis)
  • Patients post upper gastrointestinal surgery (NOTE-AF PULSE-GI)
  • Patients post vascular interventions (NOTE-AF Vasc)
  • Patients with acute respiratory failure (NOTE-AF Resp)
  • Patients admitted after acute stroke (NOTE-AF stroke)

You may not qualify if:

  • Atrial fibrillation or atrial flutter at the time of screening
  • Patients in atrial fibrillation or atrial flutter at time of preoperative assessment or admission to hospital
  • Paced cardiac rhythm
  • Inability to obtain consent
  • Allergy to plaster or silicone
  • Expected hospital stay less than 48 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Liverpool university foundation trust

Liverpool, United Kingdom

Location

Liverpool University hospital Foundation trust

Liverpool, United Kingdom

Location

Related Publications (1)

  • Essa H, Johnston B, Lip GYH, Ortega-Martorell S, Williams K, Welters ID; TARGET Consortium. Intelligent monitoring to predict atrial fibrillation (NOTE-AF): clinical study 1 for the 'Health virtual twins for the personalised management of stroke related to atrial fibrillation (TARGET)' project - a protocol for a prospective cohort analysis. BMJ Open. 2026 Jan 3;16(1):e099658. doi: 10.1136/bmjopen-2025-099658.

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2024

First Posted

September 19, 2024

Study Start

September 23, 2024

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

September 15, 2025

Record last verified: 2025-06

Locations