Efficacy Rate of Unipolar Polarity Switch for Lesion Assessment in Pulmonary Vein Isolation

Study Overview
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Brief Summary
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The technique of intraprocedural electrogram morphology as a measure of lesion effectiveness in an attempt to achieve durable PVI, clearly led to shortened procedural time, radiation exposure, and superiority in outcomes, with the implementation of a reproducible, readily available intraprocedural tool that can be applied universally.

Detailed Description
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One initial study reported that unipolar atrial EGM modification was a useful end point for RF energy delivery. They compared 2 groups of patients with paroxysmal AF undergoing PVI facilitated by an electroanatomic mapping system, merged preprocedural LA computed tomographic scan, and a circular mapping catheter. They were the first to use intraprocedural electrogram morphology as a measure of lesion effectiveness in an attempt to achieve durable PVI. The technique, clearly led to shortened procedural time, radiation exposure, and superiority in outcomes, with the implementation of a reproducible, readily available intraprocedural tool that can be applied universally. As there is scant data is this area with lack of randomized human trials, planned on building and further validating evidence from Bortone et al in demonstrating that loss of unipolar negative component during PVI can serve a great adjuvant tool for achieving durability of PVI with overall lesser procedural time and no significant increase in adverse events.

Official Title
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To Assess the Efficacy Rate of Unipolar Polarity Switch for Lesion Assessment in Pulmonary Vein Isolation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Other: Unipolar Polarity Switch Left
* Other: Unipolar Polarity Switch Right


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All Patients ≥ 18 years of age Undergoing pulmonary vein isolation for De-Novo Atrial Fibrillation. Exclusion Criteria: Patients unable to give consent Who do not have De-novo AF.

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Unipolar Polarity Switch Left and CAI-OPR-LAAP Right<br> | Other: Unipolar Polarity Switch Left<br>* 10-15 Left veins are randomized to Unipolar Polarity Shift, right veins are randomized to CAI-OPR-LAAP<br>|
| Active Comparator: CAI-OPR-LAAP Left and Unipolar Polarity Switch Right<br> | Other: Unipolar Polarity Switch Right<br>* 10-15 cases randomized to CAI-OPR-LAAP on left veins, and Unipolar Polarity Switch on right veins<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy rate of loss of unipolar negative component | Observe the efficacy rate of loss of unipolar negative component in isolation of the Pulmonary Veins. Loss of unipolar negative component will be assessed during the Radiofrequency ablation procedure. The durability of Pulmonary vein isolation will be assessed at 12 month follow up, if there is recurrence of Atrial fibrillation. | Procedure day and 12 month follow-up day | 
| Number of patients with Esophageal Injury | Number of patients with intraprocedural and post procedure adverse events and serious adverse events - Esophageal Injury | 1 year | 
| Number of patients with TIA/CVA | Number of patients with intraprocedural and post procedure adverse events and serious adverse events - transient ischemic attack/Cerebrovascular accident (TIA/CVA) | 1 year | 
| Number of patients with Bleeding/Hematoma | Number of patients with intraprocedural and post procedure adverse events and serious adverse events - Bleeding/Hematoma | 1 year | 
| Number of patients with Pericardial Effusion | Number of patients with intraprocedural and post procedure adverse events and serious adverse events - Pericardial Effusion | 1 year | 
| Number of patients with need for open heart surgery | Number of patients with intraprocedural and post procedure adverse events and serious adverse events - need for open heart surgery | 1 year | 
| Number of patients with phrenic nerve injury | Number of patients with intraprocedural and post procedure adverse events and serious adverse events - phrenic nerve injury | 1 year | 
| Number of patients with pulmonary vein stenosis | Number of patients with intraprocedural and post procedure adverse events and serious adverse events - pulmonary vein stenosis | 1 year | 
| Esophageal Temp max (existing protocol) | Esophageal temp max (existing protocol) | 1 day | 
| Esophageal Time above threshold | Esophageal Time above threshold | 1 day | 
| Esophageal Time to return to baseline | Esophageal Time to return to baseline | 1 day | 
| Images comparing PURE EP unipolar signals against Claris unipolar signals | Observe if the quality of PURE EP's unipolar signals are acutely and better suited for lesion assessment? This outcome compares mapping images with site of activation to the PURE EP electrogram and compare if they correspond to each other. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare 1st pass isolation | Compare 1st pass isolation in the Unipolar polarity switch group to Carto's Ablation Index per Overland Park Regional's Left Atrial Ablation Protocol (CAI-OPR-LAAP) | 1 day | 
| Total RF Time | Total RF Time in pulmonary veins with Unipolar polarity switch as endpoint vs. CAI-OPR-LAAP | 1 day | 
| Discrimination with High Frequency Algorithm as a confirmation tool | In Left Superior Vein, Right Superior Vein, and Right Inferior Vein, validate Near Field and Far Field Discrimination with High Frequency Algorithm as a confirmation tool (Visitag #'s annotated into PURE EP) | 1 day | 
| 6-month freedom from AF | 6-month freedom from AF | 6 months | 
| Redo's within 1 year | Redo's within 1 year which vein randomized group reconnected | 1 year | 
| Location of Catheter tip | Location of Catheter tip (LSPV, RSPV, RIPV, LIPV, LAA, Other) (carto image) | 1 day | 
| Duration of HFA channel compared to Bipolar | Duration of HFA channel compared to Bipolar, Was there both a near and far field component? | 1 day |