Specific Electrophenotypes in Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— INSPECT-AF  

Official title:

IdeNtification of SPecific EleCTrophenotypes in Atrial Fibrillation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05366530
• Other study ID #: 21HH7349
• Status: Active, not recruiting
• Start date: May 19, 2022
• Est. completion date: June 2026

Study information

• Verified date: September 2023
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• Biomarkers, electrocardiographic imaging, intracardiac electrograms, cardiac magnetic resonance imaging
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.

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from atrial fibrillation	Percentage of patients who do not have a recurrence of atrial fibrillation	1 year
Secondary	Atrial fibrillation burden	Mean number of episodes of atrial fibrillation	1 year
Secondary	Atrial fibrillation related symptoms and quality of life	Mean Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) score	1 year
Secondary	Health related quality of life	Mean Short Form 36 (SF-36) score	1 year