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Cryoballoon Pulmonary Vein Isolation Including Associated Esophageal Effects

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:
Cryoballoon Pulmonary Vein Isolation and Associated Esophageal Effects

Clinical Trial Summary

To determine the correlation between rate of temperature decline and nadir cryoballoon temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary vein isolation.

Clinical Trial Description

When treating atrial fibrillation and targeting various areas in the left atrium, electrophysiologists have the choice to perform ablation with RF energy or cryoenergy. Esophageal ulceration and in more rare cases, esophageal fistulae, are known complications of this ablation procedure. Though rare (0.1-0.25% fistula rate and 15-20% esophageal ulceration rate according to the most recent Heart Rhythm Society EHRA ECA consensus statement)1, the investigators would very much like to understand how to completely prevent these occurrences. Cryoenergy has more recently been introduced as an energy source used in the PVI procedure; therefore, for this energy source, rates of esophageal ulceration are not yet well-defined. Nine esophageal fistulae have occurred in the first approximately 130,000 cryoballoon procedures. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02998866
Study type Interventional
Source Baylor Research Institute
Contact
Status Completed
Phase N/A
Start date November 2015
Completion date February 23, 2018
View Details
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