CARTO® 3 System and Real Time Intracardiac Ultrasound

Summary

This is a prospective, multicenter, non-randomized observational study of subjects 18 years and older undergoing RF ablation with drug refractory recurrent symptomatic paroxysmal Atrial Fibrillation (AF).

Conditions

• Atrial Fibrillation
• Paroxysmal AF

Interventions

DEVICE

Catheter Ablation

NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)

Sponsors & Collaborators

• Biosense Webster, Inc.

  lead INDUSTRY

Principal Investigators

• Usman Siddiqui, MD · Osceola Regional Medical Center

• Mathew Hutchinson, MD · University of Pennsylvania

• Andy Tran, MD · Scottsdale Healthcare Research

• Saumil Oza, MD · East Coast Institute for Research LLC, St. Vincent's Ambulatory Care, Inc.

• Robert Fishel, MD · JFK Medical Center

• Vijendra Swarup, MD · AZ Heart Rhythm Research Center

• Mohit Rastogi, MD · Washington Adventist Hospital CCVR

• Brett Gidney, MD · Santa Barbara Cottage Hospital

• John Scherschel, MD · University of Nebraska

• Dilip Mathew, MD · Pepin Heart Hospital

• William Sauer, MD · University of Colorado, Denver

• Marcie Berger, MD · Medical College of Wisconsin

• Khawaja Baig, MD · Kettering Medical Center

• Farhat Khairallah, MD · Tallahassee Research Institute

• David Fitzgerald, MD · Scott & White Memorial Hospital

• Gopi Dandamudi, MD · Geisinger Heart Institute

• Ahmad Abdul-Karim, MD · Provena St. Joseph Medical Center

• Douglas Esberg, MD · Main Line Health

• Scott Burke, MD · St. Mary's Medical Center

• Gregory Jones, MD · Wellmont CVA Heart Institute

• Tapan Rami, MD · The Methodist Hospital Research Institute

• Salem Sayar, MD · Northeast Georgia Heart Center, PC

• Gunjan Shukla, MD · Hackensack Meridian Health

• Philip Gentlesk, MD · Sentara Norfolk General Hospital

• Asim Yunus, MD · Michigan CardioVascular Institute

• Scott Reich, MD · Northeast Baptist Hospital

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-10-31

Primary Completion

2013-09-30

Completion

2013-09-30

Countries

• United States

Study Locations