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

• ClinicalTrials.gov Identifier: NCT03812601
• Recruitment Status: Completed
• First Posted: January 23, 2019
• Last Update Posted: January 19, 2022
• Sponsor: Oxford University Hospitals NHS Trust
• Information provided by (Responsible Party): Tim Betts MD MBChB FRCP, Oxford University Hospitals NHS Trust

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Atrial Fibrillation	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 Design

• Study Type: Observational
• Actual Enrollment: 22 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Biatrial Global High-density Electroanatomical Mapping of Atrial Fibrillation - a Prospective Mechanistic Study
• Actual Study Start Date: October 11, 2018
• Actual Primary Completion Date: September 10, 2020
• Actual Study Completion Date: November 10, 2021

Groups and Cohorts

Intervention Details:

• Procedure: Simultaneous bi-atrial electroanatomic mapping and ablation
  Simultaneous bi-atrial electroanatomic mapping during atrial fibrillation and during pacing from 3 different vectors at varying cycle lengths followed by pulmonary vein isolation and AcQMap guided ablation of non-pulmonary vein mechanisms.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Outcome of AcQMap guided catheter ablation of atrial fibrillation [ Time Frame: 12 months ]
   Freedom from recurrent atrial fibrillation on 12 lead ECG or >30seconds on ambulatory monitoring

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing their first catheter ablation procedure for atrial fibrillation

Criteria

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.)

Contacts and Locations

Locations

United Kingdom

John Radcliffe Hospital

Oxford, Oxfordshire, United Kingdom, OX3 9DU

Sponsors and Collaborators

Oxford University Hospitals NHS Trust

Investigators

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

More Information

• Responsible Party: Tim Betts MD MBChB FRCP, Principle Investigator, Oxford University Hospitals NHS Trust
• ClinicalTrials.gov Identifier: NCT03812601
• Other Study ID Numbers: 13608
• First Posted: January 23, 2019
• Last Update Posted: January 19, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes