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ACTIVE NOT RECRUITING
NCT05393180
NA

CONVERGE Post-Approval Study (PAS)

Sponsor: AtriCure, Inc.

View on ClinicalTrials.gov

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

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. .

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