CARTO® 3 System and Real Time Intracardiac Ultrasound (IUAF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01716663|
Recruitment Status : Completed
First Posted : October 30, 2012
Results First Posted : December 1, 2014
Last Update Posted : December 1, 2014
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation Paroxysmal AF||Device: Catheter Ablation|
|Study Type :||Observational|
|Actual Enrollment :||234 participants|
|Official Title:||CARTO® 3 System and Real Time Intracardiac Ultrasound for Ablation of Drug Refractory Recurrent Symptomatic Paroxysmal AF: Acute Procedural Outcomes Study|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
Experimental: Catheter Ablation
These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.
Device: Catheter Ablation
NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)
Other Name: CARTO® 3 System and Real Time Intracardiac Ultrasound
- Total Fluoroscopy Time [ Time Frame: Day 0 ]The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.
- Total Procedure Time [ Time Frame: Day 0 ]The procedure time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.
- Acute Procedural Success [ Time Frame: Day 0 ]Acute success will be defined as confirmation of pulmonary vein isolation by entrance block, exit block, and/or periostial block of all targeted pulmonary veins.
- Mean Number of Radiofrequency (RF) Applications [ Time Frame: Day 0 ]RF application is defined as the number of times RF energy is delivered during the procedure.
- Total Radiofrequency (RF) Time [ Time Frame: Day 0 ]Total RF time is defined as the total time RF is delivered during the procedure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01716663
|Principal Investigator:||Usman Siddiqui, MD||Osceola Regional Medical Center|
|Principal Investigator:||Mathew Hutchinson, MD||University of Pennsylvania|
|Principal Investigator:||Andy Tran, MD||Scottsdale Healthcare Research|
|Principal Investigator:||Saumil Oza, MD||East Coast Institute for Research LLC, St. Vincent's Ambulatory Care, Inc.|
|Principal Investigator:||Robert Fishel, MD||JFK Medical Center|
|Principal Investigator:||Vijendra Swarup, MD||AZ Heart Rhythm Research Center|
|Principal Investigator:||Mohit Rastogi, MD||Washington Adventist Hospital CCVR|
|Principal Investigator:||Brett Gidney, MD||Santa Barbara Cottage Hospital|
|Principal Investigator:||John Scherschel, MD||University of Nebraska|
|Principal Investigator:||Dilip Mathew, MD||Pepin Heart Hospital|
|Principal Investigator:||William Sauer, MD||University of Colorado, Denver|
|Principal Investigator:||Marcie Berger, MD||Medical College of Wisconsin|
|Principal Investigator:||Khawaja Baig, MD||Kettering Medical Center|
|Principal Investigator:||Farhat Khairallah, MD||Tallahassee Research Institute|
|Principal Investigator:||David Fitzgerald, MD||Scott & White Memorial Hospital|
|Principal Investigator:||Gopi Dandamudi, MD||Geisinger Heart Institute|
|Principal Investigator:||Ahmad Abdul-Karim, MD||Provena St. Joseph Medical Center|
|Principal Investigator:||Douglas Esberg, MD||Main Line Health|
|Principal Investigator:||Scott Burke, MD||St. Mary Medical Center|
|Principal Investigator:||Gregory Jones, MD||Wellmont CVA Heart Institute|
|Principal Investigator:||Tapan Rami, MD||The Methodist Hospital Research Institute|
|Principal Investigator:||Salem Sayar, MD||Northeast Georgia Heart Center, PC|
|Principal Investigator:||Gunjan Shukla, MD||Hackensack Meridian Health|
|Principal Investigator:||Philip Gentlesk, MD||Sentara Norfolk General Hospital|
|Principal Investigator:||Asim Yunus, MD||Michigan CardioVascular Institute|
|Principal Investigator:||Scott Reich, MD||Northeast Baptist Hospital|