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INSPECT-AF: Specific Electrophenotypes in Atrial Fibrillation

Sponsor
Imperial College London (Other)
Overall Status
Recruiting
CT.gov ID
NCT05366530
Collaborator
(none)
300
Enrollment
1
Location
48.4
Anticipated Duration (Months)
6.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Biomarkers, electrocardiographic imaging, intracardiac electrograms, cardiac magnetic resonance imaging

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
IdeNtification of SPecific EleCTrophenotypes in Atrial Fibrillation
Actual Study Start Date :
May 19, 2022
Anticipated Primary Completion Date :
Jun 1, 2026
Anticipated Study Completion Date :
Jun 1, 2026

Outcome Measures

Primary Outcome Measures

  1. Freedom from atrial fibrillation [1 year]

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

Secondary Outcome Measures

  1. Atrial fibrillation burden [1 year]

    Mean number of episodes of atrial fibrillation

  2. Atrial fibrillation related symptoms and quality of life [1 year]

    Mean Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) score

  3. Health related quality of life [1 year]

    Mean Short Form 36 (SF-36) score

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Imperial College Healthcare NHS Trust London United Kingdom

Sponsors and Collaborators

  • Imperial College London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Imperial College London
ClinicalTrials.gov Identifier:
NCT05366530
Other Study ID Numbers:
  • 21HH7349
First Posted:
May 9, 2022
Last Update Posted:
Aug 8, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Atrial Fibrillation

Study Results

No Results Posted as of Aug 8, 2022