Biatrial Global High-density Electroanatomical Mapping of Atrial Fibrillation (BiMap-AF)

Biatrial Global High-density Electroanatomical Mapping of Atrial Fibrillation - a Prospective Mechanistic Study

This study uses two AcQMap imaging and electroanatomical mapping systems (Acutus Medical) to simultaneously visualise and map patterns of wavefront propagation in both the left and right atria during atrial fibrillation in order to identify mechanisms of rhythm propagation and maintenance and the importance of the interaction of the left and right atria. Mapping will also be performed during pacing from different sites and cycle lengths to identify regions of abnormal conduction that may be related to the maintenance of atrial fibrillation.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Simultaneous bi-atrial electroanatomic mapping and ablation

Detailed Description

Patients undergoing first time catheter ablation for atrial fibrillation with undergo simultaneous bi-atrial mapping using two linked AcQMap imaging and mapping systems from Acutus Medical. Mapping will be performed during AF, sinus rhythm and pacing (following cardioversion if required). Pacing will be undertaken from 3 sites in order to create different vectors of conduction and at varying cycle lengths and coupling intervals in order to identify regions of slow and anisotropic conduction. Patients will then undergo pulmonary vein isolation by radiofrequency ablation followed by ablation of non-pulmonary vein targets at the operators discretion (ablation in line with clinical practice and not as part of the study). Regions of focal firing, rotational or slow conduction during AF will be noted and the interaction between each atria described.

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• United Kingdom
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • John Radcliffe Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing their first catheter ablation procedure for atrial fibrillation

Description

Inclusion Criteria:

• Participant is willing and able to give informed consent for participation in the trial.
• Male or Female, aged 18 years or above.
• Diagnosed with paroxysmal or persistent atrial fibrillation and planned for a catheter ablation procedure.
• In the Investigator's opinion is able and willing to comply with all trial requirements.

Exclusion Criteria:

• Physical or anatomical barriers to the use of two simultaneous mapping catheters
• Previous cardiac surgery
• Previous ablation (catheter or surgical)
• Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
• Participants who have participated in another research trial involving an investigational medicinal product in the past 12 weeks. (Involvement in any other research trial is not a contraindication per se.)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spatiotemporal distribution of non-pulmonary vein focal impulses identified during non-contact mapping of atrial fibrillation	The number and location of focal impulses will be collected over 2 recordings	Catheter ablation procedure
Spatiotemporal distribution of irregular and rotational activation during 2 recordings of atrial fibrillation	Number of sites of irregular and rotational activation (LA and RA) and their frequency over time during 2 recordings of atrial fibrillation	Catheter ablation procedure
Frequency of inter-atrial wavefront propagation during AF	Proportion of wavefronts originating in each atria activating from left to right and right to left and site of inter-atrial conduction	Catheter ablation procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outcome of AcQMap guided catheter ablation of atrial fibrillation	Freedom from recurrent atrial fibrillation on 12 lead ECG or >30seconds on ambulatory monitoring	12 months

Collaborators and Investigators

• Sponsor: Oxford University Hospitals NHS Trust
• Investigators: Principal Investigator: Timothy R Betts, MB ChB, MD, Oxford University Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2018
• Primary Completion (Actual): September 10, 2020
• Study Completion (Actual): November 10, 2021

Study Registration Dates

• First Submitted: January 14, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 17, 2022
• Last Verified: January 1, 2022

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: 13608

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