Afib IDE: NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation

• Sponsor: Biosense Webster, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00116428
• Collaborator: (none)
• Enrollment: 167
• Locations: 17
• Arms: 2
• Actual Duration (Months): 76.9
• Patients Per Site: 9.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This trial compares the safety and effectiveness of catheter ablation for PAF with antiarrhythmic drug therapy. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter. At the time of this study, the NAVISTAR® THERMOCOOL® catheter was FDA-approved for commercial distribution in the U.S. for treating patients with Type I atrial flutter and drug refractory monomorphic ventricular tachycardia post myocardial infarction. The catheter was approved for use in Europe for endocardial ablation for treating cardiac arrhythmias.

Condition or Disease	Intervention/Treatment	Phase
Heart Diseases; Arrhythmia; Atrial Fibrillation	Device: NAVISTAR® THERMOCOOL® Catheter; Drug: Antiarrhythmic drug	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 167 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation
• Actual Study Start Date: Oct 1, 2004
• Actual Primary Completion Date: Oct 1, 2007
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NAVISTAR® THERMOCOOL® Catheter	Device: NAVISTAR® THERMOCOOL® Catheter; The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
Active Comparator: Antiarrhythmic drug	Drug: Antiarrhythmic drug; Subjects randomized to the antiarrhythmic drug (control) arm will be prescribed to a not previously administered class I or class III antiarrhythmic drug that is currently approved in the U.S. for treating atrial fibrillation.

Outcome Measures

Primary Outcome Measures

1. The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF) [The evaluation time frame for the THERMOCOOL catheter subjects is 91-361 days (12 months) post procedure; for Antiarrhythmic Drug Therapy subjects the time frame is 15-285 days (9 months) post procedure.]

   Chronic success was defined as freedom of documented symptomatic Atrial Fibrillation episodes based on electrocardiographic data and no changes in antiarrhythmic drugs (AAD) regimen during comparable evaluation periods for the THERMOCOOL and AAD (Control) groups through 12 and 9 months of follow-up, respectively.

2. The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Serious Catheter-related Adverse Events [Within 7 Days of Ablation Procedure]

   Catheter-related adverse events include death, myocardial infarction, pulmonary vein stenosis,diaphragmatic paralysis, atrio-esophageal fistula,transient ischemic attack,stroke,cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade,pericardial effusion,pneumothorax,atrial perforation,vascular access complications,pulmonary edema,hospitalization (initial and prolonged), and heart block.

Secondary Outcome Measures

1. The Percentage of Subjects Who Achieved Acute Success. [90 days post study procedure]

   Acute success was defined as confirmation of entrance block in all targeted pulmonary veins. The study protocol considered subjects that had more than 2 AF ablation procedures within the 90 day blanking period immediately following their index study procedure or subjects that had additional ablation procedures greater than 80 days following their original study ablation procedure as acute failures.

2. Percentage of Subjects Who Experienced Atrial Fibrillation Recurrence During the Two-year Follow up. [During the two years of post procedure]

   At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.

3. Percentage of Subjects Responded to Each of the Four Health Status Categories. [During the two years of post procedure]

   At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.

Eligibility Criteria

Criteria

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

You may be eligible to participate in this study if you: Have failed to respond to drug treatment for your AFib, or find the side effects of your medication intolerable.

Inclusion Criteria

• Patients with symptomatic PAF who have had three (3) AF episodes in the six (6) months prior to randomization, one of which must be documented. Documentation may include electrocardiogram (ECG), transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip.

• Failure of at least one AAD for PAF [class I or III or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)] as evidenced by recurrent symptomatic PAF, or intolerable side effects due to AAD.

• Signed Patient Informed Consent Form.

• Age 18 years or older.

• Able and willing to comply with all pre-, post- and follow-up testing and requirements.

Exclusion Criteria

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

• Previous ablation for atrial fibrillation.

• Patients on amiodarone therapy at any time during the previous six (6) months.

• AF episodes that last longer than 30 days and are terminated via cardioversion.

• Any valvular cardiac surgical procedure.

• CABG procedure within the last 180 days (six months).

• Awaiting cardiac transplantation or other cardiac surgery within the next 360 days (12 months).

• Documented left atrial thrombus on imaging (e.g. TEE).

• History of a documented thromboembolic event within the past one (1) year.

• Diagnosed atrial myxoma.

• Presence of implanted ICD.

• Significant pulmonary disease, (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.

• Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.

• Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable).

• Acute illness or active systemic infection or sepsis.

• Unstable angina.

• Myocardial infarction within the previous 60 days (two months).

• LVEF < 40%.

• History of blood clotting or bleeding abnormalities.

• Contraindication to anticoagulation (i.e. heparin or warfarin).

• Contraindication to CT/MRA procedure.

• Life expectancy less than 360 days (12 months).

• Enrollment in an investigational study evaluating another device or drug.

• Uncontrolled heart failure or NYHA class III or IV heart failure.

• Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.

• Presence of a condition that precludes vascular access.

• Left atrial size ≥ 50 mm

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marin General Hospital	Greenbrae	California	United States	94904
2	Florida Hospital	Orlando	Florida	United States	32803
3	Loyola University Medical Center	Maywood	Illinois	United States	60153
4	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287
5	Lahey Clinic Medical Center	Burlington	Massachusetts	United States	01805
6	St. Lukes Roosevelt Hospital	New York	New York	United States	10025
7	University of Rochester Medical Center	Rochester	New York	United States	14642
8	Ohio State University Medical Center	Columbus	Ohio	United States	43210
9	Riverside Methodist Hospital	Columbus	Ohio	United States	43241
10	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
11	Medical University of South Carolina	Charleston	South Carolina	United States	29403
12	The Heart Hospital Baylor Plano Baylor Research Institute	Plano	Texas	United States	75093
13	Inova Fairfax Hospital	Falls Church	Virginia	United States	22042
14	Hospital Sao Paulo	Sao Paulo		Brazil	04024-002
15	Montreal Heart Institute	Montreal	Quebec	Canada	H1T-iC8
16	Na Homolce Hospital	Praha 5	Motol	Czechia	150 30
17	Hospital San Raffaele	Milan		Italy	20132

Sponsors and Collaborators

• Biosense Webster, Inc.

Investigators

• Principal Investigator: David Wilber, MD, Loyola University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biosense Webster, Inc.
• ClinicalTrials.gov Identifier: NCT00116428
• Other Study ID Numbers: BWI03130
• First Posted: Jun 30, 2005
• Last Update Posted: Oct 24, 2017
• Last Verified: Sep 1, 2017

• Keywords provided by Biosense Webster, Inc.: Atrial Fibrillation; Paroxysmal Atrial Fibrillation
• Additional relevant MeSH terms: Atrial Fibrillation; Heart Diseases; Anti-Arrhythmia Agents

Study Results

Participant Flow

Recruitment Details	This pivotal study was closed to enrollment on October 12, 2007 with a total of 167 subjects enrolled at 19 investigational sites (15 US and 4 outside US).

Arm/Group Title	NAVISTAR® THERMOCOOL® Catheter	Antiarrhythmic Drug
Arm/Group Description	Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.	The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
Period Title: Overall Study
STARTED	106	61
Underwent Study Ablation Procedure	103	36
COMPLETED	103	56
NOT COMPLETED	3	5

Baseline Characteristics

Arm/Group Title	NAVISTAR® THERMOCOOL® Catheter	Antiarrhythmic Drug	Total
Arm/Group Description	Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.	The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.	Total of all reporting groups
Overall Participants	106	61	167
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.5 (9.3)	56.1 (12.8)	55.7 (10.7)
Sex: Female, Male (Count of Participants)
Female	33 31.1%	23 37.7%	56 33.5%
Male	73 68.9%	38 62.3%	111 66.5%
Race/Ethnicity, Customized (Number) [Number]
Hispanic	1 0.9%	0 0%	1 0.6%
Native American	1 0.9%	0 0%	1 0.6%
White	103 97.2%	61 100%	164 98.2%
Arab ethnicity	1 0.9%	0 0%	1 0.6%
Region of Enrollment (participants) [Number]
Brazil	7 6.6%	5 8.2%	12 7.2%
Canada	5 4.7%	3 4.9%	8 4.8%
Czech Republic	17 16%	10 16.4%	27 16.2%
Italy	31 29.2%	19 31.1%	50 29.9%
United States	46 43.4%	24 39.3%	70 41.9%
Number of documented symptomatic Atrial Fibrillation episodes (Number of episodes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Number of episodes]	62.3 (89.2)	64.9 (98.0)	63.24 (93.0)

Outcome Measures

1. Primary Outcome

Title	The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF)
Description	Chronic success was defined as freedom of documented symptomatic Atrial Fibrillation episodes based on electrocardiographic data and no changes in antiarrhythmic drugs (AAD) regimen during comparable evaluation periods for the THERMOCOOL and AAD (Control) groups through 12 and 9 months of follow-up, respectively.
Time Frame	The evaluation time frame for the THERMOCOOL catheter subjects is 91-361 days (12 months) post procedure; for Antiarrhythmic Drug Therapy subjects the time frame is 15-285 days (9 months) post procedure.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NAVISTAR® THERMOCOOL® Catheter	Antiarrhythmic Drug
Arm/Group Description	Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.	The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
Measure Participants	106	61
Number [Percentage of participants]	66 62.3%	16 26.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NAVISTAR® THERMOCOOL® Catheter, Antiarrhythmic Drug
	Comments	The study null hypothesis is that the chronic success rates for the THERMOCOOL and AAD groups are equal.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Log Rank
	Comments

2. Primary Outcome

Title	The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Serious Catheter-related Adverse Events
Description	Catheter-related adverse events include death, myocardial infarction, pulmonary vein stenosis,diaphragmatic paralysis, atrio-esophageal fistula,transient ischemic attack,stroke,cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade,pericardial effusion,pneumothorax,atrial perforation,vascular access complications,pulmonary edema,hospitalization (initial and prolonged), and heart block.
Time Frame	Within 7 Days of Ablation Procedure

Outcome Measure Data

Analysis Population Description

Analysis population includes those enrolled subjects undergoing a study ablation procedure. A total of 139 underwent the procedure, including 36 AAD (control) group subjects who underwent the procedure after failing the effectiveness endpoint. The remaining 25 AAD (control) subjects didn't have the ablation procedure.

Arm/Group Title	NAVISTAR® THERMOCOOL® Catheter	Antiarrhythmic Drug
Arm/Group Description	Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.	The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
Measure Participants	139	25
Number [Percentage of Participants]	10.1 9.5%	0.0 0%

3. Secondary Outcome

Title	The Percentage of Subjects Who Achieved Acute Success.
Description	Acute success was defined as confirmation of entrance block in all targeted pulmonary veins. The study protocol considered subjects that had more than 2 AF ablation procedures within the 90 day blanking period immediately following their index study procedure or subjects that had additional ablation procedures greater than 80 days following their original study ablation procedure as acute failures.
Time Frame	90 days post study procedure

Outcome Measure Data

Analysis Population Description

This analysis population is based on the first study ablation procedure.

Arm/Group Title	NAVISTAR® THERMOCOOL® Catheter	Antiarrhythmic Drug
Arm/Group Description	Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.	The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
Measure Participants	103	36
Number [Percentage of participants]	100 94.3%	94 154.1%

4. Secondary Outcome

Title	Percentage of Subjects Who Experienced Atrial Fibrillation Recurrence During the Two-year Follow up.
Description	At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.
Time Frame	During the two years of post procedure

Outcome Measure Data

Analysis Population Description

Subjects who completed two years follow up

Arm/Group Title	NAVISTAR® THERMOCOOL® Catheter	Antiarrhythmic Drug Subjects Undergoing Ablation	Antiarrhythmic Drug
Arm/Group Description	Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.	Control Group Subjects underwent a study ablation procedure after failing the effectiveness endpoint.	The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame.
Measure Participants	92	35	15
Number [Percentage of Participants]	29.3 27.6%	28.6 46.9%	53.3 31.9%

5. Secondary Outcome

Title	Percentage of Subjects Responded to Each of the Four Health Status Categories.
Description	At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.
Time Frame	During the two years of post procedure

Outcome Measure Data

Analysis Population Description

Subjects who completed the two-year health survey.

Arm/Group Title	NAVISTAR® THERMOCOOL® Catheter	Antiarrhythmic Drug Subjects Undergoing Ablation	Antiarrhythmic Drug
Arm/Group Description	Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.	Control subjects underwent a study ablation procedure after failing the effectiveness endpoint.	The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame.
Measure Participants	92	35	15
Two-Year Health Status: Improved	65.2 61.5%	60.0 98.4%	53.3 31.9%
Two-Year Health Status: Unchanged	29.3 27.6%	37.1 60.8%	33.3 19.9%
Two-Year Health Status: Worsened	5.4 5.1%	2.9 4.8%	6.7 4%
Two-Year Health Status: Missing	0.0 0%	0.0 0%	6.7 4%

Adverse Events

Arm/Group Title	NAVISTAR® THERMOCOOL® Catheter		Antiarrhythmic Drug
Arm/Group Description	Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization; OR received the Catheter after failing the effectiveness endpoint. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.		The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame AND didn't undergo a study ablation procedure.
All Cause Mortality
	NAVISTAR® THERMOCOOL® Catheter		Antiarrhythmic Drug
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	NAVISTAR® THERMOCOOL® Catheter		Antiarrhythmic Drug
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	25/139 (18%)		0/25 (0%)
Cardiac disorders
Pericarditis	1/139 (0.7%)	1	0/25 (0%)	0
Emergency Department Visit	2/139 (1.4%)	2	0/25 (0%)	0
General disorders
Death	2/139 (1.4%)	2	0/25 (0%)	0
Injury, poisoning and procedural complications
Pericardial Effusion	1/139 (0.7%)	1	0/25 (0%)	0
Investigations
Hospitalization	7/139 (5%)	7	0/25 (0%)	0
Renal and urinary disorders
Urinary Tract Infection	1/139 (0.7%)	1	0/25 (0%)	0
Hemoptysis/Right Kidney Stone	1/139 (0.7%)	1	0/25 (0%)	0
Neoplasm/Kidney Nodule	2/139 (1.4%)	2	0/25 (0%)	0
Hematuria	1/139 (0.7%)	1	0/25 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema	1/139 (0.7%)	1	0/25 (0%)	0
Surgical and medical procedures
Tearing of atrial septum	1/139 (0.7%)	1	0/25 (0%)	0
Vascular disorders
Vascular Access Complication	5/139 (3.6%)	5	0/25 (0%)	0
Other (Not Including Serious) Adverse Events
	NAVISTAR® THERMOCOOL® Catheter		Antiarrhythmic Drug
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	23/139 (16.5%)		0/25 (0%)
Blood and lymphatic system disorders
Hematoma	2/139 (1.4%)	2	0/25 (0%)	0
Hematoma/Bleeding/groin pain	3/139 (2.2%)	5	0/25 (0%)	0
Gastrointestinal disorders
Nausea, Vomiting/Rigors	2/139 (1.4%)	6	0/25 (0%)	0
General disorders
Chest Pain	2/139 (1.4%)	2	0/25 (0%)	0
Back pain	3/139 (2.2%)	3	0/25 (0%)	0
Injury, poisoning and procedural complications
Pericardial Effusion	2/139 (1.4%)	2	0/25 (0%)	0
Nervous system disorders
Neurologic Side Effects	3/139 (2.2%)	3	0/25 (0%)	0
Renal and urinary disorders
Hematuria	3/139 (2.2%)	3	0/25 (0%)	0
Respiratory, thoracic and mediastinal disorders
Shortness of Breath	3/139 (2.2%)	3	0/25 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The PI is allowed to publish but must submit draft publication(s) to Biosense Webster, Inc. at least 30 days prior to submission for publication or presentation.