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

NCT02028143 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-04-24

No results posted yet for this study

Summary

Imaging Real Time within the Left atrial chamber Enhances safety and efficacy of Radiofrequency Ablation of Atrial Fibrillation

Conditions

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

Sponsors & Collaborators

  • Biosense Webster, Inc.

    collaborator INDUSTRY

  • Gregory Jones

    lead OTHER

Principal Investigators

  • Gregory Jones, MD · Wellmont CVA Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-01-31
Completion
2016-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02028143 on ClinicalTrials.gov