AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery

Status: Recruiting
Location: See all (18) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The primary objective of this study is to evaluate the safety and effectiveness of the AtriCure CryoICE system in performing the Cox-Maze III lesion set, in conjunction with Left Atrial Appendage (LAA) exclusion using the AtriClip device.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Subject is greater than or equal to 18 years of age

• Subject has history of persistent or long-standing persistent atrial fibrillation as defined by the 2017 Heart Rhythm Society (HRS)/European Heart Rhythm Association (EHRA)/ European Cardiac Arrhythmia Society (ECAS) Guidelines

• Stable Subject that is scheduled to undergo non-emergent cardiac surgical procedure(s) to be performed on cardiopulmonary bypass including open-heart surgery for one or more of the following: Mitral valve repair or replacement, Aortic valve repair or replacement, Tricuspid valve repair or replacement, and Coronary artery bypass procedures

• Left Ventricular Ejection Fraction ≥ 30% (determined by echocardiography or cardiac catheterization performed within 60 days of enrollment as documented in patient medical history)

• Subject is willing and able to provide written informed consent

• Subject has a life expectancy of at least 5 years

• Subject is willing and able to return for scheduled follow-up visits.

Locations
United States
California
UCLA Medical Center
Recruiting
Los Angeles
St. Helena Hospital
Recruiting
Saint Helena
Washington, D.c.
Washington Adventist Hospital
Recruiting
Washington
Illinois
Northwestern Medicine
Recruiting
Chicago
Indiana
Franciscan Health
Recruiting
Indianapolis
Deaconess Gateway Hospital
Recruiting
Newburgh
Maryland
University Of Maryland
Recruiting
Baltimore
Michigan
University of Michigan
Recruiting
Ann Arbor
Minnesota
Mayo Clinic
Recruiting
Rochester
Missouri
St. Luke's Hospital
Recruiting
Kansas City
North Carolina
Ashville Heart/Mission Hospital
Recruiting
Asheville
New York
Mount Sinai Icahn School of Medicine
Recruiting
New York
Northwell Health Systems
Recruiting
New York
NYP-Weill Cornell
Recruiting
New York
St. Joseph Hospital Health Center
Recruiting
Syracuse
Ohio
Cleveland Clinic Foundation
Active, not recruiting
Cleveland
Tennessee
St Thomas West Hospital
Recruiting
Nashville
West Virginia
West Virginia University
Recruiting
Morgantown
Contact Information
Primary
Nfii K Ndikintum, PhD, MBA
nndikintum@atricure.com
513-644-8192
Backup
Jess Lampert
jlampert@atricure.com
612-400-5352
Time Frame
Start Date: January 30, 2019
Estimated Completion Date: December 2026
Participants
Target number of participants: 150
Treatments
Experimental: AtriCure CryoICE & AtriClip LAA Exclusion
AtriCure CryoICE system performing the Cox-Maze III lesion set, in conjunction with LAA exclusion using the AtriClip device.
Related Therapeutic Areas
Sponsors
Leads: AtriCure, Inc.

This content was sourced from clinicaltrials.gov

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