Reduction of Radiation Dose and Contrast Use During Cryoballoon Pulmonary Vein Isolation

Atrial Fibrillation Clinical Trial

Official title: Reduction of Radiation Dose and Contrast Use During Cryoballoon Pulmonary Vein Isolation

Status Completed

Clinical Trial Summary

This is a multi-site, randomized, investigator-initiated pilot study to evaluate the efficacy of investigational techniques to reduce fluoroscopy time or radiation dose and the amount of radio opaque contrast used during a cryoballoon pulmonary vein isolation procedure for atrial fibrillation.

One group of subjects will have the procedure performed with intracardiac echo maneuvers to assess cryoballoon occlusion of the pulmonary vein and will be compared to a group of subjects who will receive the standard medical treatment with fluoroscopy and angiography.

Clinical Trial Description

Surgical and catheter based technologies target triggers that initiate atrial fibrillation located in the pulmonary veins (PV). In order to isolate these triggers, radiofrequency energy or freezing is used to destroy the atrial tissue which propagate electrical impulses into and out of the pulmonary veins (PV), to achieve pulmonary vein isolation (PVI). Use of a patented cryoballoon catheter (Medtronic) to perform PVI has been shown to be safe and efficacious under fluoroscopic guidance with contrast angiography. The objective of this study is to identify methods to reduce radiation dose and radio opaque contrast use while maintaining PVI efficacy and safety. ;

Related Conditions & MeSH terms

• Atrial Fibrillation

• NCT number: NCT03786822
• Study type: Interventional
• Source: University of Texas Southwestern Medical Center
• Status: Completed
• Phase: N/A
• Start date: June 1, 2015
• Completion date: December 20, 2016