Clinical trial NCT03812601: Biatrial Global High-density Electroanatomical Mapping of Atrial Fibrillation
Official title: Biatrial Global High-density Electroanatomical Mapping of Atrial Fibrillation - a Prospective Mechanistic Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Oxford University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing their first catheter ablation procedure for atrial fibrillation

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.

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.

Eligibility 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.)

Primary outcomes:
measure: Spatiotemporal distribution of non-pulmonary vein focal impulses identified during non-contact mapping of atrial fibrillation
timeFrame: Catheter ablation procedure
measure: Spatiotemporal distribution of irregular and rotational activation during 2 recordings of atrial fibrillation
timeFrame: Catheter ablation procedure
measure: Frequency of inter-atrial wavefront propagation during AF
timeFrame: Catheter ablation procedure
Secondary outcomes:
measure: Outcome of AcQMap guided catheter ablation of atrial fibrillation
timeFrame: 12 months
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
state: Oxfordshire
Study officials:
affiliation: Oxford University Hospitals NHS Trust
name: Timothy R Betts, MB ChB, MD
role: PRINCIPAL_INVESTIGATOR
References: