Clinical trial NCT05366530: Specific Electrophenotypes in Atrial Fibrillation
Official title: IdeNtification of SPecific EleCTrophenotypes in Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing direct current cardioversion (DCCV) or catheter ablation for atrial fibrillation

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.


Eligibility criteria: 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

Primary outcomes:
measure: Freedom from atrial fibrillation
timeFrame: 1 year
Secondary outcomes:
measure: Atrial fibrillation burden
timeFrame: 1 year
measure: Atrial fibrillation related symptoms and quality of life
timeFrame: 1 year
measure: Health related quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
References: