ICE: Intracardiac Ultrasound Within the Left Atrium During Radiofrequency Ablation of Nonvalvular Atrial Fibrillation

NACompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

January 31, 2015

Study Completion Date

January 31, 2016

Conditions
Atrial Fibrillation
Interventions
DEVICE

Biosense Webster irrigated tip catheter

The second group (study group) will have the ICE catheter placed through one of two existing 8F sheaths already in the left atrium. The ICE catheter will be exchanged in the sheath utilizing the lasso multipolar mapping catheter during left pulmonary vein ablation lines. During exchange, suction and irrigation techniques will be utilized to avoid any air or thrombus embolization. All patients will have standard anticoagulation during the procedure with heparin infusion adjusted to an activated clotting time (ACT) of 350-400. The left sided ICE catheter will be adjusted to visualize left sided structures, ablation tip and tissue interface, and adjacent noncardiac structures such as the esophagus during radiofrequency ablation of the left pulmonary vein system.

DEVICE

Biosense Webster irrigated tip catheter

Group 1 will receive standard pulmonary vein isolation (PVI) procedure utilizing intracardiac guided ultrasound (ICE) placed within the right atrium via the femoral vein.

PROCEDURE

Pulmonary vein isolation

PROCEDURE

ICE catheter placed through one of two existing 8F sheaths

Trial Locations (1)

37660

Wellmont CVA Heart Institute, Kingsport

All Listed Sponsors
collaborator

Biosense Webster, Inc.

INDUSTRY

lead

Gregory Jones

OTHER

NCT02028143 - ICE: Intracardiac Ultrasound Within the Left Atrium During Radiofrequency Ablation of Nonvalvular Atrial Fibrillation | Biotech Hunter | Biotech Hunter