Start Date
December 31, 2021
Primary Completion Date
December 31, 2023
Study Completion Date
November 30, 2026
Convergence Of Epicardial And Endocardial RF Ablation
The epicardial lesion pattern will be created using the EPi-Sense®-AF Guided Coagulation System with VisiTrax®. Epicardial linear lesions will be created endoscopically using the EPi-Sense-AF Guided Coagulation System with VisiTrax throughout the posterior left atrium and along the pericardial reflections from a trans-diaphragmatic or sub-xyphoid access without any chest incisions. An endocardial ablation catheter will be used to ablate endocardially to connect lesions at the reflections, complete the isolation of the pulmonary veins and create a cavotricuspid lesion to prevent typical atrial flutter. Once the study lesion pattern has been created by coagulating cardiac tissue using the EPi- Sense-AF Guided Coagulation System and the endocardial ablation catheter, the pulmonary veins must be evaluated for entrance and/or exit block to confirm isolation.
Medstar Washington Hospital Center, Washington D.C.
Virginia Cardiovascular Specialists, Richmond
Emory University - St. Joseph's Hospital, Atlanta
St. Vincent's HealthCare, Jacksonville
Palm Beach Gardens Medical Center, Palm Beach Gardens
Grandview Medical Center, Birmingham
Heart Center Research LLC, Huntsville
Cardiology Associates Research, LLC, Tupelo
St. Bartholomew's Hospital, London
Guy's and St. Thomas Hospital, London
Lead Sponsor
AtriCure, Inc.
INDUSTRY