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

NCT05464537 | Terminated

• 1 other identifier: KCHRRF-UNIPOLAR SWITCH-0013
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (7)

• Compare 1st pass isolation

  1 day

• Total RF Time

  1 day

• Discrimination with High Frequency Algorithm as a confirmation tool

  1 day

• 6-month freedom from AF

  6 months

• Redo's within 1 year

  1 year

Study Arms (2)

Unipolar Polarity Switch Left and CAI-OPR-LAAP Right

ACTIVE COMPARATOR

Other: Unipolar Polarity Switch Left

CAI-OPR-LAAP Left and Unipolar Polarity Switch Right

ACTIVE COMPARATOR

Other: Unipolar Polarity Switch Right

Interventions

Unipolar Polarity Switch Left OTHER

10-15 Left veins are randomized to Unipolar Polarity Shift, right veins are randomized to CAI-OPR-LAAP

Unipolar Polarity Switch Left and CAI-OPR-LAAP Right

Unipolar Polarity Switch Right OTHER

10-15 cases randomized to CAI-OPR-LAAP on left veins, and Unipolar Polarity Switch on right veins

CAI-OPR-LAAP Left and Unipolar Polarity Switch Right

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Patients ≥ 18 years of age
• Undergoing pulmonary vein isolation for De-Novo Atrial Fibrillation.

You may not qualify if:

• Patients unable to give consent
• Who do not have De-novo AF.

Sponsors & Collaborators

• Kansas City Heart Rhythm Research Foundation: lead
• Kansas City Heart Rhythm Institute, Overland Park, KS: collaborator

Study Sites (2)

Kansas City Heart Rhythm Institute

Overland Park, Kansas, 66211, United States

Location

Overland Park Regional Medical Center

Overland Park, Kansas, 66215, United States

Location

Related Publications (3)

• 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.

  PMID: 26092576 BACKGROUND

• 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.

  PMID: 31164003 BACKGROUND

• 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.

  PMID: 24097371 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dhanunjaya Lakkireddy

  Kansas City Heart Rhythm Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 19, 2022
• Study Start: August 28, 2023
• Primary Completion: November 27, 2024
• Study Completion: November 27, 2024
• Last Updated: March 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)