Cryoablation System FIM/CE Mark Study

Status Completed

Clinical Trial Summary

Multi-center, open label, prospective clinical study to establish the acute safety and performance of the Cryterion Cardiac Cryoablation System

Clinical Trial Description

This is a single-arm, open-label clinical study using a cryoablation balloon device to isolate pulmonary veins during an atrial fibrillation ablation procedure. Cryo is a scientifically proven energy source used to create a thermal injury during endocardial ablation. The investigational device uses current technology with minor design modifications and will be studied to validate similarities in the safety and performance parameters compared to literature. ;

Study Design

Related Conditions & MeSH terms

Atrial Fibrillation

Clinical Trial Details

NCT number	NCT03723070
Study type	Interventional
Source	Boston Scientific Corporation
Contact
Status	Completed
Phase	N/A
Start date	May 15, 2018
Completion date	December 22, 2020

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