Continuous Ambulatory Cardiac Monitoring for Recurrent Atrial Fibrillation After Sepsis

NCT05217485 | Unknown

• 1 other identifier: CAMSAF
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

To detect atrial fibrillation after infection.

Conditions

Atrial Fibrillation; Sepsis; Infections; Cardiac Arrhythmia

Keywords

atrial fibrillation; sepsis; anticoagulation

Outcome Measures

Primary Outcomes (1)

• Quantify the incidence of early (within 14-days) AF recurrence in patients who are being discharged, following hospitalisation for an infection or sepsis and develop transient AF at CUH.

  12 months

Study Arms (1)

Infection and reverted atrial fibrillation

EXPERIMENTAL

Patients who have developed first-diagnosed atrial fibrillaiton in the context of sepsis or infection

Device: Zio 14-day cardiac patch

Interventions

Zio 14-day cardiac patch DEVICE

A wearble adhesive cardiac patch (14-day) called Zio

Infection and reverted atrial fibrillation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18
• Admission with any infection or sepsis
• Transient AF
• Under general medicine
• Can be anticoagulated or not
• Sinus rhythm at discharge or point of Zio patch placement

You may not qualify if:

• Previous history of AF or paroxysmal AF
• Age less than 18 years
• Pregnancy
• Active and known malignancy
• Recent cardiac or non-cardiac surgery (3 months)
• Recent myocardial infarction (3 months)
• Individuals with skin allergies to plasters and adhesive devices
• Chest wall deformity, skin condition over sticker site
• History of thyroid disease
• Current alcohol intake above recommended limits
• Already has a cardiac monitor or pacemaker inserted
• Known contraindication for anticoagulation therapy
• Patients who lack capacity or have an estimated life expectancy \< 1 year

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead
• University of Cambridge: collaborator

Study Sites (1)

Cambridge University Hospital NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation; Sepsis; Infections; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Systemic Inflammatory Response Syndrome; Inflammation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer

Model Details: Interventional single arm, prospective cohort

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 1, 2022
• Study Start: March 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2024
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)