NCT01585961|CompletedResults
NAVISTAR® THERMOCOOL® SF Catheter: Observational Study
SFAF
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SFAF
Sponsor study identifier
observational
511
1 country
45
Study Start
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2014
Actual (reported)Study Completion
July 2014
Actual (reported)This is a prospective, interventional, observational, unblinded, single-arm, multicenter registry of younger and older subjects with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 14, 2012
Actual (reported)April 2012
Date type not reportedThis date has not been verified as actual or estimated.
April 26, 2012
Actual (reported)July 2014
Actual (reported)July 2014
Actual (reported)January 26, 2015
Actual (reported)Total Fluoroscopy Time
The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total time.
Day 0 (procedure)
Total Procedure Time
Day 0 (procedure)
Acute Procedural Success
Confirmation of entrance and/or exit block across all targeted pulmonary veins.
Day 0 (procedure)
These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and have provided written informed consent to participate in the study, including consent to undergo catheter ablation with the study device.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Older and younger patients with drug refractory, symptomatic paroxysmal atrial fibrillation.
Heart Center Research, LLC
Huntsville, Alabama, 35801, United States
Alaska Heart Institute, LLC
Anchorage, Alaska, 99508, United States
Arizona Heart Hospital
Phoenix, Arizona, 85006, United States
Scottsdale Healthcare Research Institute
Scottsdale, Arizona, 85258, United States
Scripps Clinical Research
La Jolla, California, 92037, United States
San Diego Cardiac Center
San Diego, California, 92123, United States
UCSF Medical Center
San Francisco, California, 94143, United States
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.
511 participants (actual enrollment reported by the registry).
First Submitted
March 14, 2012
First Posted
April 26, 2012
Study Start
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
Intravenous Magnesium Infusion in Patients Undergoing Cardioversion of Atrial Fibrillation Trial
Mean Number of Radiofrequency (RF) Applications
Day 0 (procedure)
Total Radiofrequency (RF) Time
Day 0 (procedure)
Fluid Volume Delivered Via Ablation Catheter
Day 0 (procedure)
Number of Patients With Repeat Ablations
1 year
Post-procedure AF Symptoms
12 Month Visit
Contact the study team to confirm eligibility.
JFK Medical Center
Atlantis, Florida, 33462, United States
Florida Hospital Memorial Medical Center
Daytona Beach, Florida, 32117, United States
St. Vincent's Ambulatory Care, Inc.
Jacksonville, Florida, 32204, United States
Largo Medical Center
Largo, Florida, 33774, United States
Florida Hospital - Orlando
Orlando, Florida, 32803, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
St. Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342, United States
Cardiology Associates of Savannah
Savannah, Georgia, 31419, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007, United States
Prairie Education and Research Cooperative
Springfield, Illinois, 62701, United States
Lutheran Medical Group, LLC
Fort Wayne, Indiana, 46804, United States
University of Iowa Hospital & Clinics
Iowa City, Iowa, 55242, United States
University of Kansas Hospitals
Kansas City, Kansas, 66160, United States
Central Baptist Hospital
Lexington, Kentucky, 40503, United States
Baptist Hospital
Louisville, Kentucky, 40207, United States
Cardiovascular Research Foundation of Louisiana
Baton Rouge, Louisiana, 70808, United States
Washington Adventist Hospital
Takoma Park, Maryland, 20912, United States
United Heart and Vascular Clinic
Saint Paul, Minnesota, 55102, United States
St. Luke's Mid American Heart Institute
Kansas City, Missouri, 64111, United States
Bryan LGH Heart Institute
Lincoln, Nebraska, 68506, United States
The Cardiac Center of Creighton University
Omaha, Nebraska, 68131, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
New York Presbyterian Hospital, Columbia University Medical Center
New York, New York, 10032, United States
Bethesda North Hospital
Cincinnati, Ohio, 45242, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Genesis Healthcare Systems
Zanesville, Ohio, 43701, United States
Central Bucks Specialists, LTD
Doylestown, Pennsylvania, 18901, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
Centennial Heart
Nashville, Tennessee, 37203, United States
Vanderbilt Heart and Vascular Institute
Nashville, Tennessee, 37232-8802, United States
Baylor All Saints Medical Center
Fort Worth, Texas, 76104, United States
Plaza Medical Center
Grapevine, Texas, 76501, United States
Texas Heart Institute at St. Luke's Episcopal Hospital
Houston, Texas, 77030, United States
Cardiac Study Center
Tacoma, Washington, 98405, United States
Bellin Memorial Hospital, Inc.
Green Bay, Wisconsin, 54301, United States
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
Primary Completion
July 2014
Actual (reported)Study Completion
July 2014
Actual (reported)Last Updated
January 26, 2015
Results First Posted
January 26, 2015
Record last verified: 2015-01
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Source: ClinicalTrials.gov.
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