The Contact-PVI Study - Does Assessment of Tissue Contact During RF Ablation Using the St. Jude Medical™ Ensite™ Contact™ System Increase Rates of Long-term Pulmonary Vein Isolation? A Prospective Randomised Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 148
- Locations
- 2
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participant is undergoing de novo pulmonary vein isolation procedure.
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female, ≥18 years of age.
Exclusion Criteria
- •Previous percutaneous or open surgical procedure involving the left atrium
- •Pregnancy (current or currently planning)
Arms & Interventions
Contact ECI active
Contact ECI active
Intervention: ablation (Procedure)
Contact information deactivated
RF ablation without contact data
Intervention: RF ablation (Procedure)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- touch-up ablation requirements(acute (intra-procedure))
- anatomical location of reconnections at repeat procedure(at repeat ablation procerdure (6-12 months post index ablation procedure))
- complications(acute and subacute (intra-procedure, and during entire follow-up period))
- Proportion of acute venous electrical reconnections(acute (intra-procedure))
- RF time(acute (intra-procedure))
- procedure time(acute)
- amount of RF required to achieve re-isolation at repeat ablation procedure(at repeat ablation procedure (6-12 months post-index ablation procedure))