CONVERGE Post-Approval Study (PAS)

NAActive, not recruitingINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

April 13, 2022

Primary Completion Date

January 1, 2027

Study Completion Date

January 1, 2029

Conditions
Chronic Atrial Fibrillation
Interventions
DEVICE

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. ."

Trial Locations (12)

21218

MedStar Union Memorial Hospital, Baltimore

30062

Wellstar Health System, Marietta

30322

Emory Saint Joseph Hopsital, Atlanta

32806

Orlando Health, Orlando

33759

Baycare Health Systems, Clearwater

57108

Avera Heart Hospital of SD, Sioux Falls

84112

University of Utah, Salt Lake City

94107

Sutter Bay Hospitals, San Francisco

06102

Hartford Hospital, Hartford

02740

Southcoast Hospitals Group, New Bedford

08401

AtlantiCare Medical Center, Atlantic City

Se1 7EH

St Thomas, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AtriCure, Inc.

INDUSTRY