Clinical trial NCT05464537: Efficacy Rate of Unipolar Polarity Switch for Lesion Assessment in Pulmonary Vein Isolation
Official title: To Assess the Efficacy Rate of Unipolar Polarity Switch for Lesion Assessment in Pulmonary Vein Isolation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Kansas City Heart Rhythm Research Foundation
Sponsor class: OTHER
Collaborators: name: Kansas City Heart Rhythm Institute, Overland Park, KS
First posted: 2022-07-19
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy rate of loss of unipolar negative component
timeFrame: Procedure day and 12 month follow-up day
measure: Number of patients with Esophageal Injury
timeFrame: 1 year
measure: Number of patients with TIA/CVA
timeFrame: 1 year
measure: Number of patients with Bleeding/Hematoma
timeFrame: 1 year
measure: Number of patients with Pericardial Effusion
timeFrame: 1 year
measure: Number of patients with need for open heart surgery
timeFrame: 1 year
measure: Number of patients with phrenic nerve injury
timeFrame: 1 year
measure: Number of patients with pulmonary vein stenosis
timeFrame: 1 year
measure: Esophageal Temp max (existing protocol)
timeFrame: 1 day
measure: Esophageal "Time above threshold"
timeFrame: 1 day
measure: Esophageal "Time to return to baseline"
timeFrame: 1 day
measure: Images comparing PURE EP unipolar signals against Claris unipolar signals
timeFrame: 1 day
Secondary outcomes:
measure: Compare 1st pass isolation
timeFrame: 1 day
measure: Total RF Time
timeFrame: 1 day
measure: Discrimination with High Frequency Algorithm as a confirmation tool
timeFrame: 1 day
measure: 6-month freedom from AF
timeFrame: 6 months
measure: Redo's within 1 year
timeFrame: 1 year
measure: Location of Catheter tip
timeFrame: 1 day
measure: Duration of HFA channel compared to Bipolar
timeFrame: 1 day
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Kansas City Heart Rhythm Institute
state: Kansas
city: Overland Park
country: United States
facility: Overland Park Regional Medical Center
state: Kansas
Study officials:
affiliation: Kansas City Heart Rhythm Institute
name: Dhanunjaya Lakkireddy
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.