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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05464537
• Other study ID #: KCHRRF-UNIPOLAR SWITCH-0013
• Status: Recruiting
• Phase: N/A
• Start date: August 28, 2023
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Kansas City Heart Rhythm Research Foundation
• Contact: Donita Atkins
• Phone: 816-651-1969
• Email: datkins[@]kchrf.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• Unipolar Polarity Switch Left
10-15 Left veins are randomized to Unipolar Polarity Shift, right veins are randomized to CAI-OPR-LAAP
• Unipolar Polarity Switch Right
10-15 cases randomized to CAI-OPR-LAAP on left veins, and Unipolar Polarity Switch on right veins

Locations

Country	Name	City	State
United States	Kansas City Heart Rhythm Institute	Overland Park	Kansas
United States	Overland Park Regional Medical Center	Overland Park	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Kansas City Heart Rhythm Research Foundation	Kansas City Heart Rhythm Institute, Overland Park, KS

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of patients with Esophageal Injury	Number of patients with intraprocedural and post procedure adverse events and serious adverse events - Esophageal Injury	1 year
Primary	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
Primary	Number of patients with Bleeding/Hematoma	Number of patients with intraprocedural and post procedure adverse events and serious adverse events - Bleeding/Hematoma	1 year
Primary	Number of patients with Pericardial Effusion	Number of patients with intraprocedural and post procedure adverse events and serious adverse events - Pericardial Effusion	1 year
Primary	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
Primary	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
Primary	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
Primary	Esophageal Temp max (existing protocol)	Esophageal temp max (existing protocol)	1 day
Primary	Esophageal "Time above threshold"	Esophageal "Time above threshold"	1 day
Primary	Esophageal "Time to return to baseline"	Esophageal "Time to return to baseline"	1 day
Primary	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	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
Secondary	Total RF Time	Total RF Time in pulmonary veins with Unipolar polarity switch as endpoint vs. CAI-OPR-LAAP	1 day
Secondary	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
Secondary	6-month freedom from AF	6-month freedom from AF	6 months
Secondary	Redo's within 1 year	Redo's within 1 year which vein randomized group reconnected	1 year
Secondary	Location of Catheter tip	Location of Catheter tip (LSPV, RSPV, RIPV, LIPV, LAA, Other) (carto image)	1 day
Secondary	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