CONVERGE CAP Study-For The Treatment Of Symptomatic Persistent or Long-standing Persistent AF

NAWithdrawnINTERVENTIONAL
0
Timeline

Start Date

December 31, 2021

Primary Completion Date

December 31, 2023

Study Completion Date

November 30, 2026

Conditions
Atrial Fibrillation
Interventions
DEVICE

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.

Trial Locations (10)

20010

Medstar Washington Hospital Center, Washington D.C.

23229

Virginia Cardiovascular Specialists, Richmond

30342

Emory University - St. Joseph's Hospital, Atlanta

32204

St. Vincent's HealthCare, Jacksonville

33410

Palm Beach Gardens Medical Center, Palm Beach Gardens

35243

Grandview Medical Center, Birmingham

35801

Heart Center Research LLC, Huntsville

38801

Cardiology Associates Research, LLC, Tupelo

E1 1BB

St. Bartholomew's Hospital, London

SE1 7EH

Guy's and St. Thomas Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AtriCure, Inc.

INDUSTRY

NCT04239534 - CONVERGE CAP Study-For The Treatment Of Symptomatic Persistent or Long-standing Persistent AF | Biotech Hunter | Biotech Hunter