Efficacy Rate of Unipolar Polarity Switch for Lesion Assessment in Pulmonary Vein Isolation
NCT ID: NCT05464537
Last Updated: 2025-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
8 participants
INTERVENTIONAL
2023-08-28
2024-11-27
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Unipolar Polarity Switch Left and CAI-OPR-LAAP Right
Unipolar Polarity Switch Left
10-15 Left veins are randomized to Unipolar Polarity Shift, right veins are randomized to CAI-OPR-LAAP
CAI-OPR-LAAP Left and Unipolar Polarity Switch Right
Unipolar Polarity Switch Right
10-15 cases randomized to CAI-OPR-LAAP on left veins, and Unipolar Polarity Switch on right veins
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Undergoing pulmonary vein isolation for De-Novo Atrial Fibrillation.
Exclusion Criteria
* Who do not have De-novo AF.
18 Years
ALL
No
Sponsors
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Kansas City Heart Rhythm Institute, Overland Park, KS
UNKNOWN
Kansas City Heart Rhythm Research Foundation
OTHER
Responsible Party
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Principal Investigators
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Dhanunjaya Lakkireddy
Role: PRINCIPAL_INVESTIGATOR
Kansas City Heart Rhythm Institute
Locations
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Kansas City Heart Rhythm Institute
Overland Park, Kansas, United States
Overland Park Regional Medical Center
Overland Park, Kansas, United States
Countries
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References
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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.
Other Identifiers
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KCHRRF-UNIPOLAR SWITCH-0013
Identifier Type: -
Identifier Source: org_study_id
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