The Contact PVI Study: Use of Tissue Contact Data to Guide Atrial Fibrillation Ablation

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: ablation
* Procedure: RF ablation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Contact ECI active<br>Contact ECI active | Procedure: ablation<br>* RF ablation to the left atrium of the heart, guided by ECI-contact information (active arm)<br>* Other names: Percutaneous transvenous catheter ablation;|
| Placebo Comparator: Contact information deactivated<br>RF ablation without contact data | Procedure: RF ablation<br>* RF ablation to the left atrium of the heart, without the use of ECI-contact information (control arm)<br>* Other names: Percutaneous transvenous catheter ablation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | acute (intra-procedure) | 
| touch-up ablation requirements | proportion of veins requiring additional ablation after initial successful isolation, at the end of the index procedure | acute (intra-procedure) | 
| procedure time | duration of procedure | acute | 
| RF time | total amount of radiofrequency ablation required | 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 | 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 | at repeat ablation procedure (6-12 months post-index ablation procedure) | 
| complications | procedure-related complications | acute and subacute (intra-procedure, and during entire follow-up period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, ablation, contact