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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
8
10-15 Left veins are randomized to Unipolar Polarity Shift, right veins are randomized to CAI-OPR-LAAP
10-15 cases randomized to CAI-OPR-LAAP on left veins, and Unipolar Polarity Switch on right veins
Kansas City Heart Rhythm Institute
Overland Park, Kansas, United States
Overland Park Regional Medical Center
Overland Park, Kansas, United States
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.
Time frame: 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
Time frame: 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)
Time frame: 1 year
Number of patients with Bleeding/Hematoma
Number of patients with intraprocedural and post procedure adverse events and serious adverse events - Bleeding/Hematoma
Time frame: 1 year
Number of patients with Pericardial Effusion
Number of patients with intraprocedural and post procedure adverse events and serious adverse events - Pericardial Effusion
Time frame: 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
Time frame: 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
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Time frame: 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
Time frame: 1 year
Esophageal Temp max (existing protocol)
Esophageal temp max (existing protocol)
Time frame: 1 day
Esophageal "Time above threshold"
Esophageal "Time above threshold"
Time frame: 1 day
Esophageal "Time to return to baseline"
Esophageal "Time to return to baseline"
Time frame: 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.
Time frame: 1 day
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)
Time frame: 1 day
Total RF Time
Total RF Time in pulmonary veins with Unipolar polarity switch as endpoint vs. CAI-OPR-LAAP
Time frame: 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)
Time frame: 1 day
6-month freedom from AF
6-month freedom from AF
Time frame: 6 months
Redo's within 1 year
Redo's within 1 year which vein randomized group reconnected
Time frame: 1 year
Location of Catheter tip
Location of Catheter tip (LSPV, RSPV, RIPV, LIPV, LAA, Other) (carto image)
Time frame: 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?
Time frame: 1 day