At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
To Assess the Efficacy Rate of Unipolar Polarity Switch for Lesion Assessment in Pulmonary Vein Isolation
In Brief
A clinical study evaluating Unipolar Polarity Switch Left and Unipolar Polarity Switch Right for Atrial Fibrillation. Terminated early, enrolled 8 participants across 2 sites.
Signals
Detailed 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.
Study Details
Timeline
Interventions
10-15 Left veins are randomized to Unipolar Polarity Shift, right veins are randomized to CAI-OPR-LAAP
10-15 cases randomized to CAI-OPR-LAAP on left veins, and Unipolar Polarity Switch on right veins