Atrial fibrillation Circulatory System
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the trial 2. Male or female, aged 18 years or above 3. Diagnosed with paroxysmal or persistent atrial fibrillation and planned for a catheter ablation procedure 4. In the Investigator’s opinion is able and willing to comply with all trial requirements
Exclusion criteria
Exclusion criteria: 1. Physical or anatomical barriers to the use of two simultaneous mapping catheters 2. Previous cardiac surgery 3. Previous ablation (catheter or surgical) 4. Female participant who is pregnant, lactating or planning pregnancy during the course of the trial 5. 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 6. 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence and number of pre-defined electrophysiological phenomena such as “rotors” and “focal firing”; Timepoint(s): during ablation procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Freedom from recurrent atrial fibrillation, defined as that seen on 12-lead ECG recording or >30 seconds on ambulatory monitoring at 12 months 2. Difference in conduction velocity, measured as a single vector and average vector in each atrial segment at longest and shortest cycle length and 3 vectors during catheter ablation procedure | — |
Countries
United Kingdom