Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
511 participants
OBSERVATIONAL
2012-04-30
2014-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
NAVISTAR® THERMOCOOL® Catheter Post Approval Registry
NCT00964392
NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation
NCT00116428
Navi-Star Thermo-Cool Catheter For Ablation of Atrial Fibrillation
NCT00584415
NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation- Treatment Use Study
NCT00721149
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS
NCT01639495
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Catheter Ablation
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age 18 years or older
* Patients must be able and willing to provide written informed consent to participate in the study
Exclusion Criteria
* Previous ablation for atrial fibrillation
* Episodes of atrial fibrillation that last longer than 30 days and are terminated via cardioversion
* Uncontrolled heart failure, or NYHA Class III or IV heart failure
* Documented intra-atrial thrombus or other abnormality on pre-ablation echocardiogram
* Contraindication to anticoagulation
* Stroke, cardiac surgery, unstable angina, myocardial infarction or percutaneous coronary intervention within the past 3 months
* Awaiting cardiac transplantation
* Heart disease in which corrective surgery is anticipated within 6 months
* Enrollment in investigational drug, biologic or device study
* Subjects unwilling to comply with protocol or follow-up requirements
* Patients who are pregnant
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biosense Webster, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gery Tomassoni, MD
Role: PRINCIPAL_INVESTIGATOR
Central Baptist Hospital
Scott Pollak, MD
Role: PRINCIPAL_INVESTIGATOR
Florida Hospital - Orlando
Andy Tran, MD
Role: PRINCIPAL_INVESTIGATOR
Scottsdale Healthcare Research Institute
Saumil Oza, MD
Role: PRINCIPAL_INVESTIGATOR
St. Vincent's Ambulatory Care, Inc.
Steven Compton, MD
Role: PRINCIPAL_INVESTIGATOR
Alaska Heart Institute, LLC
Anshul Patel, MD
Role: PRINCIPAL_INVESTIGATOR
St. Joseph's Hospital of Atlanta
Robert Fishel, MD
Role: PRINCIPAL_INVESTIGATOR
JFK Medical Center
Kenneth Civello, MD
Role: PRINCIPAL_INVESTIGATOR
Cardiovascular Research Foundation of Louisiana
Gaurang Gandhi, MD
Role: PRINCIPAL_INVESTIGATOR
Bethesda North Hospital
Alexandru Costea, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Sreedhar Billakanty, MD
Role: PRINCIPAL_INVESTIGATOR
Riverside Methodist Hospital
H. James Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Florida Hospital Memorial Medical Center
John Harding, MD
Role: PRINCIPAL_INVESTIGATOR
Central Bucks Specialists, Ltd.
Mohammed Khan, MD
Role: PRINCIPAL_INVESTIGATOR
Alexian Brothers Medical Center
Vijay Jayachandran, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor All Saints Medical Center
Sree Karanam, MD
Role: PRINCIPAL_INVESTIGATOR
Lutheran Medical Group, LLC
M. Craig Delaughter, MD
Role: PRINCIPAL_INVESTIGATOR
Plaza Medical Center
Mohammad Jazayeri, MD
Role: PRINCIPAL_INVESTIGATOR
Bellin Memorial Hospital, Inc.
Abdi Rasekh, MD
Role: PRINCIPAL_INVESTIGATOR
Texas Heart Institute at St. Luke's Episcopal Hospital
Scott Allison, MD
Role: PRINCIPAL_INVESTIGATOR
Heart Center Research, LLC
Alexander Mazur, MD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa Hospital & Clinics
Dhanunjaya Lakkireddy, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Hospitals
Alan Wimmer, MD
Role: PRINCIPAL_INVESTIGATOR
St. Luke's Hospital Mid American Heart Institute
Ali Hamzei, MD
Role: PRINCIPAL_INVESTIGATOR
Scripps Clinical Research
Shalin Shah, MD
Role: PRINCIPAL_INVESTIGATOR
Largo Medical Center
Michael Kutayli, MD
Role: PRINCIPAL_INVESTIGATOR
Bryan LGH Heart Institute
John Mandrola, MD
Role: PRINCIPAL_INVESTIGATOR
Baptist Hospital
Stuart Beldner, MD
Role: PRINCIPAL_INVESTIGATOR
North Shore University Hospital
Joshua Moss, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Greg Bashian, MD
Role: PRINCIPAL_INVESTIGATOR
Centennial Heart
Patrick Whalen, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt Heart and Vascular Institute
Angelo Biviano, MD
Role: PRINCIPAL_INVESTIGATOR
New York Presbyterian Hospital, Columbia University Medical Center
Hussam Abuissa, MD
Role: PRINCIPAL_INVESTIGATOR
The Cardiac Center of Creighton University
Sumeet Mainigi, MD
Role: PRINCIPAL_INVESTIGATOR
Albert Einstein Medical Center
Charles Athill, MD
Role: PRINCIPAL_INVESTIGATOR
San Diego Cardiac Center
Edward Gerstenfeld, MD
Role: PRINCIPAL_INVESTIGATOR
UCSF Medical Center
Michael Chisner, MD
Role: PRINCIPAL_INVESTIGATOR
Cardiology Associates of Savannah
Vijendra Swarup, MD
Role: PRINCIPAL_INVESTIGATOR
Arizona Heart Hospital
Ziad Issa, MD
Role: PRINCIPAL_INVESTIGATOR
Prairie Education and Research Cooperative
Tariq Salam, MD
Role: PRINCIPAL_INVESTIGATOR
Cardiac Study Center
Sung Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Washington Adventist Hospital
M. Magdy Migeed, MD
Role: PRINCIPAL_INVESTIGATOR
Genesis Healthcare Systems
Jonathan Sussman, MD
Role: PRINCIPAL_INVESTIGATOR
Morristown Medical Center
Bengt Herweg, MD
Role: PRINCIPAL_INVESTIGATOR
Tampa General Hospital
Pierce Vatterott, MD
Role: PRINCIPAL_INVESTIGATOR
United Heart and Vascular Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Heart Center Research, LLC
Huntsville, Alabama, United States
Alaska Heart Institute, LLC
Anchorage, Alaska, United States
Arizona Heart Hospital
Phoenix, Arizona, United States
Scottsdale Healthcare Research Institute
Scottsdale, Arizona, United States
Scripps Clinical Research
La Jolla, California, United States
San Diego Cardiac Center
San Diego, California, United States
UCSF Medical Center
San Francisco, California, United States
JFK Medical Center
Atlantis, Florida, United States
Florida Hospital Memorial Medical Center
Daytona Beach, Florida, United States
St. Vincent's Ambulatory Care, Inc.
Jacksonville, Florida, United States
Largo Medical Center
Largo, Florida, United States
Florida Hospital - Orlando
Orlando, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
St. Joseph's Hospital of Atlanta
Atlanta, Georgia, United States
Cardiology Associates of Savannah
Savannah, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
Prairie Education and Research Cooperative
Springfield, Illinois, United States
Lutheran Medical Group, LLC
Fort Wayne, Indiana, United States
University of Iowa Hospital & Clinics
Iowa City, Iowa, United States
University of Kansas Hospitals
Kansas City, Kansas, United States
Central Baptist Hospital
Lexington, Kentucky, United States
Baptist Hospital
Louisville, Kentucky, United States
Cardiovascular Research Foundation of Louisiana
Baton Rouge, Louisiana, United States
Washington Adventist Hospital
Takoma Park, Maryland, United States
United Heart and Vascular Clinic
Saint Paul, Minnesota, United States
St. Luke's Mid American Heart Institute
Kansas City, Missouri, United States
Bryan LGH Heart Institute
Lincoln, Nebraska, United States
The Cardiac Center of Creighton University
Omaha, Nebraska, United States
Morristown Medical Center
Morristown, New Jersey, United States
North Shore University Hospital
Manhasset, New York, United States
New York Presbyterian Hospital, Columbia University Medical Center
New York, New York, United States
Bethesda North Hospital
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Genesis Healthcare Systems
Zanesville, Ohio, United States
Central Bucks Specialists, LTD
Doylestown, Pennsylvania, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States
Centennial Heart
Nashville, Tennessee, United States
Vanderbilt Heart and Vascular Institute
Nashville, Tennessee, United States
Baylor All Saints Medical Center
Fort Worth, Texas, United States
Plaza Medical Center
Grapevine, Texas, United States
Texas Heart Institute at St. Luke's Episcopal Hospital
Houston, Texas, United States
Cardiac Study Center
Tacoma, Washington, United States
Bellin Memorial Hospital, Inc.
Green Bay, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ThermoCool SF Phase IV
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.