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CONVERGE Post-Approval Study (PAS)
Sponsor: AtriCure, Inc.
Summary
The primary objective of CONVERGE PAS is to evaluate clinical outcomes (peri-procedural and long-term) in a cohort of patients treated during commercial use of the EPi-Sense® Guided Coagulation System or EPi-Sense ST™ Coagulation System to treat symptomatic long-standing persistent atrial fibrillation (AF) patients who are refractory or intolerant to at least one Class I and/or III AAD.
Official title: Hybrid Convergent of Epicardial and Endocardial RF Ablation for the Treatment of Symptomatic Longstanding Persistent AF
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
53
Start Date
2022-04-13
Completion Date
2029-01-01
Last Updated
2025-11-24
Healthy Volunteers
No
Conditions
Interventions
Epicardial And Endocardial RF Ablation For The Treatment Of Symptomatic Long-standing Persistent AF
Epicardial linear lesions will be created endoscopically using the EPi-Sense®-Guided Coagulation System or EPi-Sense ST™ Coagulation System throughout the posterior left atrium and along the pericardial reflections from a trans-diaphragmatic or sub-xyphoid access without any chest incisions. Posterior and other linear lesions such as a roof lesion and mitral valve isthmus lesion will not be created during the endocardial component of the convergent procedure. This will be done endocardially using an irrigated endocardial ablation catheter. Once the study lesion pattern has been created by coagulating cardiac tissue using the EPi-Sense®-Guided Coagulation System or EPi-Sense ST™ Coagulation System and the endocardial ablation catheter, the pulmonary veins must be evaluated for entrance and/or exit block to confirm isolation. .
Locations (13)
Sutter Bay Hospitals
San Francisco, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Baycare Health Systems
Clearwater, Florida, United States
Orlando Health
Orlando, Florida, United States
Emory Saint Joseph Hopsital
Atlanta, Georgia, United States
Wellstar Health System
Marietta, Georgia, United States
Norton Heart & Vascular Institute
Louisville, Kentucky, United States
MedStar Union Memorial Hospital
Baltimore, Maryland, United States
Southcoast Hospitals Group
New Bedford, Massachusetts, United States
AtlantiCare Medical Center
Atlantic City, New Jersey, United States
Avera Heart Hospital of SD
Sioux Falls, South Dakota, United States
University of Utah
Salt Lake City, Utah, United States
St Thomas
London, United Kingdom