Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, ablation, contact
Brief summary
This study aims to investigate the benefit of a new impedance-based computer software application during routine catheter ablation for atrial fibrillation, to see if this information improves short and long term electrical disconnection of the pulmonary veins. This study will be a single blind prospective randomised control trial in patients undergoing AF ablation. Study participants will be randomly assigned to undergo parts of their pulmonary vein ablation with, and parts of their ablation without tissue contact data displayed for the doctor performing the ablation to see. The pulmonary veins will then be studied at the end of the procedure, and at any repeat procedure in the future, to look for a difference in the recovery rate of the ablations performed using contact data, compared to those ablations performed without the use of this contact data. If a reduction in tissue recovery is achieved through the use of this tissue contact data, it may lead in the future to a reduced need for repeat ablation procedures, and better outcomes for patients. The investigators hypothesise that the use of the Ensite™ Contact™ ECI data will reduce the recovery of conduction, and promote long-term pulmonary vein isolation in patients undergoing left atrial ablation for atrial fibrillation.
Interventions
PROCEDUREablation
RF ablation to the left atrium of the heart, guided by ECI-contact information (active arm)
PROCEDURERF ablation
RF ablation to the left atrium of the heart, without the use of ECI-contact information (control arm)
Sponsors
Oxford University Hospitals NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participant is undergoing de novo pulmonary vein isolation procedure. 2. Participant is willing and able to give informed consent for participation in the study. 3. Male or Female, ≥18 years of age.
Exclusion criteria
1. Previous percutaneous or open surgical procedure involving the left atrium 2. Pregnancy (current or currently planning)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be the proportion (%) of pulmonary vein pairs found to be reconnected electrically to the left atrium at a subsequent redo ablation procedure | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| touch-up ablation requirements | acute (intra-procedure) | proportion of veins requiring additional ablation after initial successful isolation, at the end of the index procedure |
| procedure time | acute | duration of procedure |
| RF time | acute (intra-procedure) | total amount of radiofrequency ablation required |
| Proportion of acute venous electrical reconnections | acute (intra-procedure) | proportion of pulmonary veins found to be electrically reconnected to the left atrium at the end of the index procedure |
| amount of RF required to achieve re-isolation at repeat ablation procedure | at repeat ablation procedure (6-12 months post-index ablation procedure) | total time of RF delivery required to re-isolate the reconnected pulmonary veins at a repeat ablation procedure |
| complications | acute and subacute (intra-procedure, and during entire follow-up period) | procedure-related complications |
| anatomical location of reconnections at repeat procedure | at repeat ablation procerdure (6-12 months post index ablation procedure) | anatomical location of electrical reconnections in pulmonary vein antra, as measured at a repeat ablation procedure |
Countries
United Kingdom
Outcome results
None listed