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

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

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.

Study Overview

• Status: Terminated
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: Unipolar Polarity Switch Left; Other: Unipolar Polarity Switch Right

Detailed Description

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
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Kansas City Heart Rhythm Institute
    • Overland Park, Kansas, United States, 66215
      • Overland Park Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kansas City Heart Rhythm Research Foundation
• Collaborators: Kansas City Heart Rhythm Institute, Overland Park, KS
• Investigators: Principal Investigator: Dhanunjaya Lakkireddy, Kansas City Heart Rhythm Institute

Publications and helpful links

General Publications

• Bortone A, Brault-Noble G, Appetiti A, Marijon E. Elimination of the negative component of the unipolar atrial electrogram as an in vivo marker of transmural lesion creation: acute study in canines. Circ Arrhythm Electrophysiol. 2015 Aug;8(4):905-11. doi: 10.1161/CIRCEP.115.002894. Epub 2015 Jun 19.
• Pambrun T, Durand C, Constantin M, Masse A, Marra C, Meillet V, Haissaguerre M, Jais P, Bortone A. High-Power (40-50 W) Radiofrequency Ablation Guided by Unipolar Signal Modification for Pulmonary Vein Isolation: Experimental Findings and Clinical Results. Circ Arrhythm Electrophysiol. 2019 Jun;12(6):e007304. doi: 10.1161/CIRCEP.119.007304. Epub 2019 Jun 5.
• Bortone A, Appetiti A, Bouzeman A, Maupas E, Ciobotaru V, Boulenc JM, Pujadas-Berthault P, Rioux P. Unipolar signal modification as a guide for lesion creation during radiofrequency application in the left atrium: prospective study in humans in the setting of paroxysmal atrial fibrillation catheter ablation. Circ Arrhythm Electrophysiol. 2013 Dec;6(6):1095-102. doi: 10.1161/CIRCEP.113.000749. Epub 2013 Oct 4.

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2023
• Primary Completion (Actual): November 27, 2024
• Study Completion (Actual): November 27, 2024

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: KCHRRF-UNIPOLAR SWITCH-0013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No