SFAF: NAVISTAR® THERMOCOOL® SF Catheter: Observational Study

• Sponsor: Biosense Webster, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01585961
• Collaborator: (none)
• Enrollment: 511
• Locations: 45
• Duration (Months): 27
• Patients Per Site: 11.4
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation; Paroxysmal Arrhythmia	Device: Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter)

Detailed Description

This study is to measure the "real-world" acute procedural outcomes (procedural efficiency, acute safety, and effectiveness at one year) associated with use of the NAVISTAR® THERMOCOOL® SF Catheter in a clinical setting in subjects with drug refractory, recurrent symptomatic paroxysmal atrial fibrillation.

Study Design

• Study Type: Observational
• Actual Enrollment: 511 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: NAVISTAR® THERMOCOOL® SF Catheter: Observational Study in a Younger and Older Drug Refractory, Recurrent, Symptomatic Paroxysmal AF Population
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.	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.

Outcome Measures

Primary Outcome Measures

1. Total Fluoroscopy Time [Day 0 (procedure)]

   The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total time.

2. Total Procedure Time [Day 0 (procedure)]

3. Acute Procedural Success [Day 0 (procedure)]

   Confirmation of entrance and/or exit block across all targeted pulmonary veins.

Secondary Outcome Measures

1. Mean Number of Radiofrequency (RF) Applications [Day 0 (procedure)]

   RF applications is defined as the number of times RF energy is delivered during the procedure.

2. Total Radiofrequency (RF) Time [Day 0 (procedure)]

   Total RF time is defined as the total time that RF energy is delivered during the procedure.

3. Fluid Volume Delivered Via Ablation Catheter [Day 0 (procedure)]

4. Number of Patients With Repeat Ablations [1 year]

5. Post-procedure AF Symptoms [12 Month Visit]

   Symptoms attributed to paroxysmal atrial fibrillation reported at 12 month visit

6. Number of Subjects With Lost Work Days, Related to AF, at 12 Month Visit [12 Month Visit]

7. Number of Patients With Inpatient Hospital Visit(s) Related to Atrial Fibrillation [12 Month Visit]

8. Number of Patients With Outpatient Emergency Visits Related to Atrial Fibrillation [12 Month Visit]

9. Change in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score [Screening to 12 Month Visit]

   Change is calculated as 12 month overall AFEQT score minus score at screening. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). Therefore a positive change in score corresponds to improvement in AF symptoms.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation

• Age 18 years or older

• Patients must be able and willing to provide written informed consent to participate in the study

Exclusion Criteria:

• Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Heart Center Research, LLC	Huntsville	Alabama	United States	35801
2	Alaska Heart Institute, LLC	Anchorage	Alaska	United States	99508
3	Arizona Heart Hospital	Phoenix	Arizona	United States	85006
4	Scottsdale Healthcare Research Institute	Scottsdale	Arizona	United States	85258
5	Scripps Clinical Research	La Jolla	California	United States	92037
6	San Diego Cardiac Center	San Diego	California	United States	92123
7	UCSF Medical Center	San Francisco	California	United States	94143
8	JFK Medical Center	Atlantis	Florida	United States	33462
9	Florida Hospital Memorial Medical Center	Daytona Beach	Florida	United States	32117
10	St. Vincent's Ambulatory Care, Inc.	Jacksonville	Florida	United States	32204
11	Largo Medical Center	Largo	Florida	United States	33774
12	Florida Hospital - Orlando	Orlando	Florida	United States	32803
13	Tampa General Hospital	Tampa	Florida	United States	33606
14	St. Joseph's Hospital of Atlanta	Atlanta	Georgia	United States	30342
15	Cardiology Associates of Savannah	Savannah	Georgia	United States	31419
16	University of Chicago Medical Center	Chicago	Illinois	United States	60637
17	Alexian Brothers Medical Center	Elk Grove Village	Illinois	United States	60007
18	Prairie Education and Research Cooperative	Springfield	Illinois	United States	62701
19	Lutheran Medical Group, LLC	Fort Wayne	Indiana	United States	46804
20	University of Iowa Hospital & Clinics	Iowa City	Iowa	United States	55242
21	University of Kansas Hospitals	Kansas City	Kansas	United States	66160
22	Central Baptist Hospital	Lexington	Kentucky	United States	40503
23	Baptist Hospital	Louisville	Kentucky	United States	40207
24	Cardiovascular Research Foundation of Louisiana	Baton Rouge	Louisiana	United States	70808
25	Washington Adventist Hospital	Takoma Park	Maryland	United States	20912
26	United Heart and Vascular Clinic	St. Paul	Minnesota	United States	55102
27	St. Luke's Mid American Heart Institute	Kansas City	Missouri	United States	64111
28	Bryan LGH Heart Institute	Lincoln	Nebraska	United States	68506
29	The Cardiac Center of Creighton University	Omaha	Nebraska	United States	68131
30	Morristown Medical Center	Morristown	New Jersey	United States	07960
31	North Shore University Hospital	Manhasset	New York	United States	11030
32	New York Presbyterian Hospital, Columbia University Medical Center	New York	New York	United States	10032
33	Bethesda North Hospital	Cincinnati	Ohio	United States	45242
34	University of Cincinnati	Cincinnati	Ohio	United States	45267
35	Riverside Methodist Hospital	Columbus	Ohio	United States	43214
36	Genesis Healthcare Systems	Zanesville	Ohio	United States	43701
37	Central Bucks Specialists, LTD	Doylestown	Pennsylvania	United States	18901
38	Albert Einstein Medical Center	Philadelphia	Pennsylvania	United States	19141
39	Centennial Heart	Nashville	Tennessee	United States	37203
40	Vanderbilt Heart and Vascular Institute	Nashville	Tennessee	United States	37232-8802
41	Baylor All Saints Medical Center	Fort Worth	Texas	United States	76104
42	Plaza Medical Center	Grapevine	Texas	United States	76501
43	Texas Heart Institute at St. Luke's Episcopal Hospital	Houston	Texas	United States	77030
44	Cardiac Study Center	Tacoma	Washington	United States	98405
45	Bellin Memorial Hospital, Inc.	Green Bay	Wisconsin	United States	54301

Sponsors and Collaborators

• Biosense Webster, Inc.

Investigators

• Principal Investigator: Gery Tomassoni, MD, Central Baptist Hospital
• Principal Investigator: Scott Pollak, MD, Florida Hospital - Orlando
• Principal Investigator: Andy Tran, MD, Scottsdale Healthcare Research Institute
• Principal Investigator: Saumil Oza, MD, St. Vincent's Ambulatory Care, Inc.
• Principal Investigator: Steven Compton, MD, Alaska Heart Institute, LLC
• Principal Investigator: Anshul Patel, MD, St. Joseph's Hospital of Atlanta
• Principal Investigator: Robert Fishel, MD, JFK Medical Center
• Principal Investigator: Kenneth Civello, MD, Cardiovascular Research Foundation of Louisiana
• Principal Investigator: Gaurang Gandhi, MD, Bethesda North Hospital
• Principal Investigator: Alexandru Costea, MD, University of Cincinnati
• Principal Investigator: Sreedhar Billakanty, MD, Riverside Methodist Hospital
• Principal Investigator: H. James Wang, MD, Florida Hospital Memorial Medical Center
• Principal Investigator: John Harding, MD, Central Bucks Specialists, Ltd.
• Principal Investigator: Mohammed Khan, MD, Alexian Brothers Medical Center
• Principal Investigator: Vijay Jayachandran, MD, Baylor All Saints Medical Center
• Principal Investigator: Sree Karanam, MD, Lutheran Medical Group, LLC
• Principal Investigator: M. Craig Delaughter, MD, Plaza Medical Center
• Principal Investigator: Mohammad Jazayeri, MD, Bellin Memorial Hospital, Inc.
• Principal Investigator: Abdi Rasekh, MD, Texas Heart Institute at St. Luke's Episcopal Hospital
• Principal Investigator: Scott Allison, MD, Heart Center Research, LLC
• Principal Investigator: Alexander Mazur, MD, University of Iowa Hospital & Clinics
• Principal Investigator: Dhanunjaya Lakkireddy, MD, University of Kansas Hospitals
• Principal Investigator: Alan Wimmer, MD, St. Luke's Hospital Mid American Heart Institute
• Principal Investigator: Ali Hamzei, MD, Scripps Clinical Research
• Principal Investigator: Shalin Shah, MD, Largo Medical Center
• Principal Investigator: Michael Kutayli, MD, Bryan LGH Heart Institute
• Principal Investigator: John Mandrola, MD, Baptist Hospital
• Principal Investigator: Stuart Beldner, MD, North Shore University Hospital
• Principal Investigator: Joshua Moss, MD, University of Chicago
• Principal Investigator: Greg Bashian, MD, Centennial Heart
• Principal Investigator: Patrick Whalen, MD, Vanderbilt Heart and Vascular Institute
• Principal Investigator: Angelo Biviano, MD, New York Presbyterian Hospital, Columbia University Medical Center
• Principal Investigator: Hussam Abuissa, MD, The Cardiac Center of Creighton University
• Principal Investigator: Sumeet Mainigi, MD, Albert Einstein Medical Center
• Principal Investigator: Charles Athill, MD, San Diego Cardiac Center
• Principal Investigator: Edward Gerstenfeld, MD, UCSF Medical Center
• Principal Investigator: Michael Chisner, MD, Cardiology Associates of Savannah
• Principal Investigator: Vijendra Swarup, MD, Arizona Heart Hospital
• Principal Investigator: Ziad Issa, MD, Prairie Education and Research Cooperative
• Principal Investigator: Tariq Salam, MD, Cardiac Study Center
• Principal Investigator: Sung Lee, MD, Washington Adventist Hospital
• Principal Investigator: M. Magdy Migeed, MD, Genesis Healthcare Systems
• Principal Investigator: Jonathan Sussman, MD, Morristown Medical Center
• Principal Investigator: Bengt Herweg, MD, Tampa General Hospital
• Principal Investigator: Pierce Vatterott, MD, United Heart and Vascular Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biosense Webster, Inc.
• ClinicalTrials.gov Identifier: NCT01585961
• Other Study ID Numbers: ThermoCool SF Phase IV
• First Posted: Apr 26, 2012
• Last Update Posted: Jan 26, 2015
• Last Verified: Jan 1, 2015

• Keywords provided by Biosense Webster, Inc.: Symptomatic paroxysmal; Atrial fibrillation; Observational; Acute procedural outcomes; Ablation; Drug refractory; Arrhythmia Recurrent; Symptomatic
• Additional relevant MeSH terms: Atrial Fibrillation; Arrhythmias, Cardiac

Study Results

Participant Flow

Arm/Group Title	Catheter Ablation
Arm/Group Description	These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study. 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.
Period Title: Overall Study
STARTED	511
Safety	508
COMPLETED	478
NOT COMPLETED	33

Baseline Characteristics

Arm/Group Title	Catheter Ablation
Arm/Group Description	These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study. 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.
Overall Participants	511
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	265 51.9%
>=65 years	246 48.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.0 (11.5)
Sex: Female, Male (Count of Participants)
Female	194 38%
Male	317 62%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	12 2.3%
Not Hispanic or Latino	494 96.7%
Unknown or Not Reported	5 1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.2%
Asian	5 1%
Native Hawaiian or Other Pacific Islander	2 0.4%
Black or African American	18 3.5%
White	477 93.3%
More than one race	2 0.4%
Unknown or Not Reported	6 1.2%
Region of Enrollment (participants) [Number]
United States	511 100%

Outcome Measures

1. Primary Outcome

Title	Total Fluoroscopy Time
Description	The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total time.
Time Frame	Day 0 (procedure)

Outcome Measure Data

Analysis Population Description

Subset of Safety Population with non-missing endpoint data.

Arm/Group Title	Catheter Ablation
Arm/Group Description	These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study. 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.
Measure Participants	506
Mean (Standard Deviation) [minutes]	26.4 (21.4)

2. Primary Outcome

Title	Total Procedure Time
Time Frame	Day 0 (procedure)

Outcome Measure Data

Analysis Population Description

Subset of Safety Population with non-missing endpoint data.

Arm/Group Title	Catheter Ablation
Arm/Group Description	These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study. 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.
Measure Participants	507
Mean (Standard Deviation) [minutes]	169.8 (82.9)

3. Primary Outcome

Title	Acute Procedural Success
Description	Confirmation of entrance and/or exit block across all targeted pulmonary veins.
Time Frame	Day 0 (procedure)

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Catheter Ablation
Arm/Group Description	These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study. 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.
Measure Participants	508
Number [participants]	488 95.5%

4. Secondary Outcome

Title	Mean Number of Radiofrequency (RF) Applications
Description	RF applications is defined as the number of times RF energy is delivered during the procedure.
Time Frame	Day 0 (procedure)

Outcome Measure Data

Analysis Population Description

Subset of Safety Population with non-missing endpoint data.

Arm/Group Title	Catheter Ablation
Arm/Group Description	These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study. 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.
Measure Participants	489
Mean (Standard Deviation) [number of applications]	45.0 (35.1)

5. Secondary Outcome

Title	Total Radiofrequency (RF) Time
Description	Total RF time is defined as the total time that RF energy is delivered during the procedure.
Time Frame	Day 0 (procedure)

Outcome Measure Data

Analysis Population Description

Subset of Safety Population with non-missing endpoint data.

Arm/Group Title	Catheter Ablation
Arm/Group Description	These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study. 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.
Measure Participants	505
Mean (Standard Deviation) [minutes]	57.9 (37.0)

6. Secondary Outcome

Title	Fluid Volume Delivered Via Ablation Catheter
Time Frame	Day 0 (procedure)

Outcome Measure Data

Analysis Population Description

Subset of Safety Population with non-missing endpoint data.

Arm/Group Title	Catheter Ablation
Arm/Group Description	These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study. 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.
Measure Participants	495
Mean (Standard Deviation) [mL]	974.2 (481.8)

7. Secondary Outcome

Title	Number of Patients With Repeat Ablations
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Catheter Ablation
Arm/Group Description	These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study. 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.
Measure Participants	508
Number [participants]	74 14.5%

8. Secondary Outcome

Title	Post-procedure AF Symptoms
Description	Symptoms attributed to paroxysmal atrial fibrillation reported at 12 month visit
Time Frame	12 Month Visit

Outcome Measure Data

Analysis Population Description

Subset of Safety Population with non-missing endpoint data.

Arm/Group Title	Catheter Ablation
Arm/Group Description	These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study. 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.
Measure Participants	470
Number [participants]	155 30.3%

9. Secondary Outcome

Title	Number of Subjects With Lost Work Days, Related to AF, at 12 Month Visit
Time Frame	12 Month Visit

Outcome Measure Data

Analysis Population Description

Subset of Safety Population with non-missing endpoint data.

Arm/Group Title	Catheter Ablation
Arm/Group Description	These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study. 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.
Measure Participants	477
Number [participants]	20 3.9%

10. Secondary Outcome

Title	Number of Patients With Inpatient Hospital Visit(s) Related to Atrial Fibrillation
Time Frame	12 Month Visit

Outcome Measure Data

Analysis Population Description

Population with Utilization Data

Arm/Group Title	Catheter Ablation
Arm/Group Description	These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study. 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.
Measure Participants	489
Number [participants]	73 14.3%

11. Secondary Outcome

Title	Number of Patients With Outpatient Emergency Visits Related to Atrial Fibrillation
Time Frame	12 Month Visit

Outcome Measure Data

Analysis Population Description

Population with Utilization Data

Arm/Group Title	Catheter Ablation
Arm/Group Description	These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study. 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.
Measure Participants	489
Number [participants]	56 11%

12. Secondary Outcome

Title	Change in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score
Description	Change is calculated as 12 month overall AFEQT score minus score at screening. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). Therefore a positive change in score corresponds to improvement in AF symptoms.
Time Frame	Screening to 12 Month Visit

Outcome Measure Data

Analysis Population Description

Subset of Safety Population with non-missing AFEQT data at 12 months.

Arm/Group Title	Catheter Ablation
Arm/Group Description	These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study. 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.
Measure Participants	462
Mean (Standard Deviation) [units on a scale]	36.0 (23.7)

Adverse Events

Time Frame	Procedure through 7 days post-procedure
Arm/Group Title	Catheter Ablation
Arm/Group Description	These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study. 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.
All Cause Mortality
	Catheter Ablation
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Catheter Ablation
	Affected / at Risk (%)	# Events
Total	63/508 (12.4%)
Blood and lymphatic system disorders
Anemia	3/508 (0.6%)	3
Leukocytosis	1/508 (0.2%)	1
Cardiac disorders
Atrial fibrillation	9/508 (1.8%)	9
Cardiac tamponade	4/508 (0.8%)	4
Pericardial effusion	4/508 (0.8%)	4
Pericarditis	2/508 (0.4%)	2
Cardiac failure congestive	3/508 (0.6%)	3
Atrial tachycardia	2/508 (0.4%)	2
Atrial flutter	1/508 (0.2%)	1
Cardiac arrest	1/508 (0.2%)	1
Cardiac perforation	1/508 (0.2%)	1
Sick sinus syndrome	1/508 (0.2%)	1
Gastrointestinal disorders
Abdominal pain	1/508 (0.2%)	1
Dysphagia	1/508 (0.2%)	1
Gastrointestinal hemorrhage	1/508 (0.2%)	1
Intestinal obstruction	1/508 (0.2%)	1
General disorders
Catheter site hematoma	3/508 (0.6%)	3
Device difficult to use (foley)	1/508 (0.2%)	1
Non-cardiac chest pain	2/508 (0.4%)	2
Pyrexia	1/508 (0.2%)	1
Infections and infestations
Pneumonia	3/508 (0.6%)	3
Urinary tract infection	1/508 (0.2%)	1
Injury, poisoning and procedural complications
Subdural hematoma	1/508 (0.2%)	1
Vascular pseudoaneurysm	2/508 (0.4%)	2
Investigations
International normalized ratio decreased	3/508 (0.6%)	3
Electrocardiogram ST segment depression	1/508 (0.2%)	1
Hematocrit decreased	1/508 (0.2%)	1
Hemoglobin decreased	1/508 (0.2%)	1
Metabolism and nutrition disorders
Hyperglycemia	1/508 (0.2%)	1
Hyponatremia	3/508 (0.6%)	3
Nervous system disorders
Syncope	1/508 (0.2%)	1
Transient global amnesia	1/508 (0.2%)	1
Renal and urinary disorders
Hematuria	1/508 (0.2%)	1
Proteinuria	1/508 (0.2%)	1
Renal failure acute	1/508 (0.2%)	1
Urinary retention	2/508 (0.4%)	2
Respiratory, thoracic and mediastinal disorders
Pleural effusion	2/508 (0.4%)	2
Acute respiratory failure	1/508 (0.2%)	1
Bronchospasm	1/508 (0.2%)	1
Chronic obstructive pulmonary disease	1/508 (0.2%)	1
Dyspnea exertional	1/508 (0.2%)	1
Epistaxis	1/508 (0.2%)	1
Hypoxia	1/508 (0.2%)	1
Vascular disorders
Femoral artery aneurysm	1/508 (0.2%)	1
Hypotension	2/508 (0.4%)	2
Intra-abdominal hematoma	1/508 (0.2%)	1
Other (Not Including Serious) Adverse Events
	Catheter Ablation
	Affected / at Risk (%)	# Events
Total	79/508 (15.6%)
Cardiac disorders
Atrial fibrillation	15/508 (3%)	15
Pericarditis	9/508 (1.8%)	9
Gastrointestinal disorders
Nausea	8/508 (1.6%)	8
General disorders
Pyrexia	6/508 (1.2%)	6
Injury, poisoning and procedural complications
Catheter site hematoma	11/508 (2.2%)	11
Catheter site hemorrhage	17/508 (3.3%)	17
Metabolism and nutrition disorders
Fluid Overload	7/508 (1.4%)	7
Musculoskeletal and connective tissue disorders
Back pain	11/508 (2.2%)	11
Nervous system disorders
Dizziness	7/508 (1.4%)	7
Respiratory, thoracic and mediastinal disorders
Dyspnea	7/508 (1.4%)	7
Vascular disorders
Hypotension	6/508 (1.2%)	6

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is an agreement between the Principal Investigator (PI)/Institution and the Sponsor (or its agents) that restricts the PI's rights to discuss, present, or publish trial results after the trial is completed. Please contact Biosense Webster for additional information.