Specific Electrophenotypes in Atrial Fibrillation (INSPECT-AF)

IdeNtification of SPecific EleCTrophenotypes in Atrial Fibrillation

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: Biomarkers, electrocardiographic imaging, intracardiac electrograms, cardiac magnetic resonance imaging

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Fu Siong Ng, PhD FRCP; Phone Number: +44 (0)20 7594 3614; Email: f.ng@imperial.ac.uk
• Study Contact Backup: Name: Arunashis Sau, MBBS MRCP; Phone Number: +44 (0)20 7594 3614; Email: as7909@imperial.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom
    • Imperial College Healthcare NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from atrial fibrillation	Percentage of patients who do not have a recurrence of atrial fibrillation	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial fibrillation burden	Mean number of episodes of atrial fibrillation	1 year
Atrial fibrillation related symptoms and quality of life	Mean Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) score	1 year
Health related quality of life	Mean Short Form 36 (SF-36) score	1 year

Collaborators and Investigators

• Sponsor: Imperial College London

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 4, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 21HH7349

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No