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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
148
RF ablation to the left atrium of the heart, guided by ECI-contact information (active arm)
RF ablation to the left atrium of the heart, without the use of ECI-contact information (control arm)
John Radcliffe Hospital
Headington, Oxfordshire, United Kingdom
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
Time frame: 6 months
Proportion of acute venous electrical reconnections
proportion of pulmonary veins found to be electrically reconnected to the left atrium at the end of the index procedure
Time frame: acute (intra-procedure)
touch-up ablation requirements
proportion of veins requiring additional ablation after initial successful isolation, at the end of the index procedure
Time frame: acute (intra-procedure)
procedure time
duration of procedure
Time frame: acute
RF time
total amount of radiofrequency ablation required
Time frame: acute (intra-procedure)
anatomical location of reconnections at repeat procedure
anatomical location of electrical reconnections in pulmonary vein antra, as measured at a repeat ablation procedure
Time frame: at repeat ablation procerdure (6-12 months post index ablation procedure)
amount of RF required to achieve re-isolation at repeat ablation procedure
total time of RF delivery required to re-isolate the reconnected pulmonary veins at a repeat ablation procedure
Time frame: at repeat ablation procedure (6-12 months post-index ablation procedure)
complications
procedure-related complications
Time frame: acute and subacute (intra-procedure, and during entire follow-up period)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.