Specific Electrophenotypes in Atrial Fibrillation

NCT05366530 | Terminated Results

• 1 other identifier: 21HH7349
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate a common heart rhythm disturbance (arrhythmia), atrial fibrillation (AF), to improve understanding of how best to treat it in different patients. Direct current cardioversion (DCCV) is a procedure that can revert the heart to a normal rhythm, however almost all patients will only have a transient benefit, and their heart will return to the abnormal rhythm, AF. Ablation is an invasive procedure that creates scar tissue within the heart to reduce the arrhythmias, with a longer lasting effect than DCCV. It has been used with success in AF that occurs occasionally (paroxysmal) but is not as effective in AF that is more long-lasting, also known as persistent AF. Persistent AF is major cause of symptoms of breathlessness and palpitations and significantly increases the risk of stroke. Doctors are unable to accurately predict which patients will benefit most from an ablation, this can lead to as many as 50% of patients not benefitting from the procedure. The aim is to better predict which patients will benefit from an ablation. The study will include patients undergoing AF ablation or DCCV and perform additional tests including blood tests a heart MRI scan, a special type of heart tracing with up to 252 points and a short period of extra recordings from within the heart during the ablation procedure. Several techniques will be used to analyse this data, including machine learning, to develop a means predict which patients will benefit the most from the ablation procedure, without needing to use any recordings from within the heart.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Freedom From Atrial Fibrillation

  Percentage of patients who do not have a recurrence of atrial fibrillation

  1 year

Interventions

Biomarkers, electrocardiographic imaging, intracardiac electrograms, cardiac magnetic resonance imaging OTHER

ECGi is a non-invasive body surface mapping technique that collects electrocardiographic data using 252 leads, and combines it with subject specific anatomic data acquired from cross sectional imaging to recreate epicardial electrograms.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing direct current cardioversion (DCCV) or catheter ablation for atrial fibrillation

You may qualify if:

• Suitable candidate for catheter mapping/ablation for arrhythmias or direct current cardioversion for atrial fibrillation
• Signed Informed Consent

You may not qualify if:

• Severe cerebrovascular disease
• Moderate to severe renal impairment (eGFR \< 30)
• Active gastrointestinal bleeding
• Active infection or fever
• Short life expectancy
• Significant anaemia
• Severe uncontrolled systemic hypertension
• Severe electrolyte imbalance
• Congestive heart failure - NYHA Class IV
• Recent myocardial infarction
• Bleeding or clotting disorders
• Uncontrolled diabetes
• Inability to receive IV or oral Anticoagulants
• Unable to give informed consent
• Pregnancy

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Biomarkers

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Factors

Limitations and Caveats

The study was stopped early due to new findings from other research that suggested this study was no longer had scientific value

Results Point of Contact

• Title: Arunashis Sau
• Organization: Imperial College London

as7909@ic.ac.uk

02075942735

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 9, 2022
• Study Start: May 19, 2022
• Primary Completion: August 27, 2024
• Study Completion: August 27, 2024
• Last Updated: March 12, 2026
• Results First Posted: March 12, 2026

Record last verified: 2026-02

Locations

GB (1)