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

Kansas City Heart Rhythm Research Foundation

Status: Enrolling

Conditions: Atrial Fibrillation

Treatments: Other: Unipolar Polarity Switch Right; Other: Unipolar Polarity Switch Left

Study type: Interventional

Funder types: Other

Identifiers

NCT05464537

KCHRRF-UNIPOLAR SWITCH-0013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Unipolar Polarity Switch Left and CAI-OPR-LAAP Right

Active Comparator group

Treatment:

Other: Unipolar Polarity Switch Left

CAI-OPR-LAAP Left and Unipolar Polarity Switch Right

Active Comparator group

Treatment:

Other: Unipolar Polarity Switch Right