Realistic Computational Electrophysiology Simulations for the Targetted Treatment of Atrial Fibrillation (ReCETT-AF)

May 15, 2024 updated by: University of Edinburgh
The aim of this research is to classify patients by the dominant mechanism of continuous atrial electrical activation during atrial fibrillation. This approach seeks to improve on existing classifications which are based solely on the duration of the arrhythmia (<7 days, >7 days and >1 year). This is a cohort study. Patients undergoing clinically indicated electrophysiology study or AF ablation will have invasive assessment of cardiac electrophysiological profile at the time of their planned procedure, undergo 2-week ambulatory monitoring before and after the procedure, complete symptom questionnaires before and after their procedure and undergo atrial cardiac magnetic resonance imaging before their procedure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Atrial fibrillation is a common condition causing an irregular heartbeat, breathlessness and tiredness. Atrial fibrillation occurs owing to abnormalities in the electrical circuits controlling the upper heart chambers. Atrial fibrillation can be treated with a keyhole procedure called ablation. During ablation small areas in the heart are burnt away to stop the abnormal circuits causing atrial fibrillation. Unfortunately, ablation only works for 50-90% of people. We are not sure why, but possibly because the electrical circuits responsible are different in every heart. This research will examine how these electrical circuits can be identified and treated. A new system using computer modelling will be developed to identify the electrical circuits present. In the future we hope this approach could be used to design tailor-made treatments for each patient. A combination of computer studies and studies involving patients will be used to test this new approach in this study. For this study patients who are already planned to undergo an ablation procedure will be recruited providing data for three Work Packages. Consent will be sought to access routine investigations and data for research purposes (e.g. ECGs, blood tests, ambulatory monitoring, cardiac imaging, and outpatient clinical assessment); and collect extra data for research including additional cardiac imaging, a 2-week heart monitor pre- and post-ablation, and extra electrical measurements made during the ablation procedure.

Study Type

Observational

Enrollment (Estimated)

115

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Up to 115 patients undergoing electrophysiological assessment will be recruited with inclusion and exclusion criteria as indicated above.

Description

Inclusion Criteria:

  • Symptomatic paroxysmal atrial fibrillation or persistent atrial fibrillation diagnosed - within 24 months preceding the consent date.
  • Planned radiofrequency ablation for atrial fibrillation consisting of pulmonary vein isolation.
  • Able and willing to comply with study follow-up requirements
  • Able and willing to provide written informed consent

Exclusion Criteria:

  • Any clinical contra-indication to ablation
  • Any disease limiting life expectancy to < 1year
  • Contra-indication to MRI including renal dysfunction (eGFR<30ml/min)
  • Potential participant currently pregnant or breast feeding
  • Prior ablation, cardiac surgery or presence of any prosthetic valves
  • Myocardial infarction or percutaneous coronary intervention within 3 months preceding consent date
  • Hypertrophic cardiomyopathy or other inherited cardiac condition
  • Presence / likely implant of any pacemaker, cardiac resynchronization therapy device or implantable defibrillator within 1 year
  • Enrolment in an existing interventional atrial fibrillation study which alters treatment or follow-up.
  • Use of amiodarone for any indication within 6 months prior to the planned ablation procedure
  • Use of any anti-arrhythmic drug for an arrhythmia indication other than atrial fibrillation
  • Prior documented cavotricuspid isthmus dependent right atrial flutter and planned cavotricuspid isthmus ablation to be performed at the time of atrial fibrillation ablation
  • Unable to understand verbal or written explanations given in English or German as appropriate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Atrial fibrillation patients undergoing radiofrequency catheter ablation
Up to 115 patients undergoing radiofrequency catheter ablation will be enrolled.
Diagnostic test: Atrial cardiac magnetic resonance imaging
To include assessment of atrial size, shape, function, fibrosis and fat
Diagnostic test: Atrial electro-anatomic mapping
To include assessment of atrial voltage and local activation time
Other: Atrial fibrillation symptom questionnaire
To include assessment of atrial fibrillation symptoms and quality of life
Diagnostic test: Patch-based 2 week ambulatory monitor
To assess atrial fibrillation burden post-ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with each mechanism of atrial fibrillation defined by computational modelling
Time Frame: 4 years
The primary outcome is the creation of patient specific computational models for the investigation of atrial fibrillation mechanisms in patients. Mechanisms of atrial fibrillation will be defined based on computational modelling results and each patient will be assigned to the dominant mechanism of atrial fibrillation present.
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrial properties - atrial structural and functional properties will be compared between patients in each mechanistic atrial fibrillation group (as defined in Outcome 1)
Time Frame: 4 years
The secondary outcome (1) is to determine which atrial properties are associated with each mechanism of atrial fibrillation in patients. Atrial structural and functional properties will be measured using atrial magnetic resonance imaging and invasive atrial electrophysiology; and quantified as follows: Atrial structure - volume (ml), sphericity (%); fibrosis burden (%); pericardial fat volume (ml); Atrial function - conduction velocity (m/s); refractoriness (ms); atrial electrical area (cm).
4 years
Treatment effects - burden of atrial fibrillation in patients classified as 'successfully treated' compared to those classified as 'not successfully treated' using the modelling framework (as defined in Outcome 1)
Time Frame: 4 years
The secondary outcome (2) is to determine how atrial properties can be modified using currently-available therapies to improve treatment for atrial fibrillation. Computer simulations will be performed in which the critical atrial properties (as defined in Outcome 2) are modified and actual treatment response will be compared to predicted treatment response by (A) correlating actual atrial fibrillation burden (% time in atrial fibrillation) with predicted atrial fibrillation burden (% time in atrial fibrillation) and (B) calculating diagnostic accuracy metrics (sensitivity, specificity, C-statistic) for prediction of atrial fibrillation inducibility and recurrence following ablation.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

King's College London

Investigators

  • Principal Investigator: Mark D O'Neill, FRCP, Guy's and St Thomas' NHS Foundation Trust London
  • Principal Investigator: Neil Grubb, FRCP, NHS Lothian, Edinburgh
  • Principal Investigator: Andreas Rillig, MD, University Heart and Vascular Center, Hamburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

January 6, 2026

Study Registration Dates

First Submitted

September 16, 2021

First Submitted That Met QC Criteria

September 16, 2021

First Posted (Actual)

September 27, 2021

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 15, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC20151

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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