NAVISTAR® THERMOCOOL® SF Catheter: Observational Study

Summary

This is a prospective, interventional, observational, unblinded, single-arm, multicenter registry of younger and older subjects with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation.

Conditions

• Atrial Fibrillation
• Paroxysmal Arrhythmia

Interventions

DEVICE

Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter)

Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.

Sponsors & Collaborators

• Biosense Webster, Inc.

  lead INDUSTRY

Principal Investigators

• Gery Tomassoni, MD · Central Baptist Hospital

• Scott Pollak, MD · Florida Hospital - Orlando

• Andy Tran, MD · Scottsdale Healthcare Research Institute

• Saumil Oza, MD · St. Vincent's Ambulatory Care, Inc.

• Steven Compton, MD · Alaska Heart Institute, LLC

• Anshul Patel, MD · St. Joseph's Hospital of Atlanta

• Robert Fishel, MD · JFK Medical Center

• Kenneth Civello, MD · Cardiovascular Research Foundation of Louisiana

• Gaurang Gandhi, MD · Bethesda North Hospital

• Alexandru Costea, MD · University of Cincinnati

• Sreedhar Billakanty, MD · Riverside Methodist Hospital

• H. James Wang, MD · Florida Hospital Memorial Medical Center

• John Harding, MD · Central Bucks Specialists, Ltd.

• Mohammed Khan, MD · Alexian Brothers Medical Center

• Vijay Jayachandran, MD · Baylor All Saints Medical Center

• Sree Karanam, MD · Lutheran Medical Group, LLC

• M. Craig Delaughter, MD · Plaza Medical Center

• Mohammad Jazayeri, MD · Bellin Memorial Hospital, Inc.

• Abdi Rasekh, MD · Texas Heart Institute at St. Luke's Episcopal Hospital

• Scott Allison, MD · Heart Center Research, LLC

• Alexander Mazur, MD · University of Iowa Hospital & Clinics

• Dhanunjaya Lakkireddy, MD · University of Kansas Hospitals

• Alan Wimmer, MD · St. Luke's Hospital Mid American Heart Institute

• Ali Hamzei, MD · Scripps Clinical Research

• Shalin Shah, MD · Largo Medical Center

• Michael Kutayli, MD · Bryan LGH Heart Institute

• John Mandrola, MD · Baptist Hospital

• Stuart Beldner, MD · North Shore University Hospital

• Joshua Moss, MD · University of Chicago

• Greg Bashian, MD · Centennial Heart

• Patrick Whalen, MD · Vanderbilt Heart and Vascular Institute

• Angelo Biviano, MD · New York Presbyterian Hospital, Columbia University Medical Center

• Hussam Abuissa, MD · The Cardiac Center of Creighton University

• Sumeet Mainigi, MD · Albert Einstein Medical Center

• Charles Athill, MD · San Diego Cardiac Center

• Edward Gerstenfeld, MD · UCSF Medical Center

• Michael Chisner, MD · Cardiology Associates of Savannah

• Vijendra Swarup, MD · Arizona Heart Hospital

• Ziad Issa, MD · Prairie Education and Research Cooperative

• Tariq Salam, MD · Cardiac Study Center

• Sung Lee, MD · Washington Adventist Hospital

• M. Magdy Migeed, MD · Genesis Healthcare Systems

• Jonathan Sussman, MD · Morristown Medical Center

• Bengt Herweg, MD · Tampa General Hospital

• Pierce Vatterott, MD · United Heart and Vascular Clinic

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-04-30

Primary Completion

2014-07-31

Completion

2014-07-31

Countries

• United States

Study Locations