Clinical Evaluation of the Blazer Open-Irrigated Ablation... | NCT01687166

Label	Type	Description	Intervention Names
Blazer Open-Irrigated Ablation Catheter	Experimental	Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system	Device: Blazer Open-Irrigated Ablation Catheter (Boston Scientific)
FDA Approved Open-Irrigated Ablation Catheter	Active Comparator	FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.	Device: FDA Approved Open-Irrigated Ablation Catheter

Name	Type	Description	Arm Group Labels	Other Names
Blazer Open-Irrigated Ablation Catheter (Boston Scientific)	Device		Blazer Open-Irrigated Ablation Catheter
FDA Approved Open-Irrigated Ablation Catheter

Measure	Description	Time Frame
Procedure-related Complication Free Rate	The safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group serious adverse event rate is non-inferior to that of the control group. The safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group rate of significant pulmonary vein stenosis (≥70% reduction in diameter from baseline) and atrio-esophageal fistulas is non-inferior to that of the control group.	12 Months
Chronic Success Rate	The primary effectiveness of the Blazer OI catheter will be evaluated by demonstrating that the proportion of subjects free from failure* in the investigational group is non-inferior to those in the control group. *failure is defined as a randomized subject being an acute procedural failure, having more than one repeat procedure during the 90 day blanking period or having a documented symptomatic atrial fibrillation, atrial tachycardia, atrial fibrillation between 91 days and 12 months post-procedure.	Within 12 months of the index procedure

Measure	Description	Time Frame
Acute Success	Demonstration that the investigational group acute procedural success rate is non-inferior to that of the control group. Acute procedural success is defined as a subject that successfully had all clinically relevant veins electrically isolated, by demonstration of entrance block at a minimum and no evidence of exit conduction with the randomized investigational or control catheter only.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

History of recurrent symptomatic PAF with ≥2 episodes reported within the 365 days prior to enrollment

o PAF is AF episodes that last ≥30 seconds in duration and terminate within 7 days.
At least 1 episode of PAF documented by Holter monitor, rhythm strip, trans-telephonic monitor (TTM), or 12-lead ECG in the 365 days prior to enrollment
Refractory to at least one Beta Blocker, Calcium Channel Blocker, Class I OR Class III anti-arrhythmic drug (AAD)
Age 18 or above, or of legal age to give informed consent specific to state and national law
Competent and willing to provide written informed consent to participate in the study and agree to comply with follow-up visits and evaluation

Exclusion Criteria:

Have any of the following heart conditions within 90 days prior to enrollment:
- New York Heart Association (NYHA) Class III or IV
- Left ventricular ejection fraction (LVEF) <35%
- Left atrial (LA) diameter >5.5 cm
- Unstable angina or ongoing myocardial ischemia
- Transmural myocardial infarction (MI)
Congenital structural heart disease that increases the risk of ablation or precludes catheter placement
Undergone any left atrial catheter or surgical ablation
Have had a coronary intervention, cardiac surgery, or other cardiac ablation within 90 days prior to enrollment
Had >1 AF episode lasting greater than 7 days, with no episodes having lasted greater than 30 days, within the past year
Subjects regularly prescribed amiodarone therapy during the 120 days prior to enrollment
Contraindication to anticoagulation therapy
Creatinine >2.5mg/dl or creatinine clearance <30mL/min within 90 days (3 months) prior to enrollment
Prosthetic mitral or tricuspid heart valves
Confirmed cardiac thrombus within 30 days (1 month) prior to enrollment
Implanted pacemaker, ICD, or CRT leads within 180 days (6 months) prior to enrollment
History of CVA, TIA or PE within 180 days (6 months) prior to enrollment
Left atrial appendage closure device
Any other significant uncontrolled or unstable medical condition (e.g. sepsis, acute metabolic illness, end stage COPD)
Enrolled in any concurrent clinical trial without documented pre-approval from BSC
Women who are pregnant or plan to become pregnant within the course of their participation in the investigation
Life expectancy ≤ 2 years (730 days) per physician opinion

Name	Affiliation	Role
Andrea Natale, M.D.	Texas Cardiac Arrhythmia Institute at St. David's Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35233	United States
Hunstville Hospital

ID	Title	Description
FG000	Blazer Open-Irrigated Ablation Catheter	Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system Blazer Open-Irrigated Ablation Catheter (Boston Scientific)
FG001	Control

Type

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Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Procedure-related Complication Free Rate

The safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group serious adverse event rate is non-inferior to that of the control group.

The safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group rate of significant pulmonary vein stenosis (≥70% reduction in diameter from baseline) and atrio-esophageal fistulas is non-inferior to that of the control group.

Outcome Measures were not assessed for the non-randomized participants.

Posted

Count of Participants

Participants

12 Months

ID	Title	Description
OG000	Blazer Open-Irrigated Ablation Catheter	Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system Blazer Open-Irrigated Ablation Catheter (Boston Scientific)
OG001	Control	FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation. FDA Approved Open-Irrigated Ablation Catheter

Units	Counts
Participants	OG000157 OG001164

Title

Denominators

Categories

Title	Measurements
	OG000140 OG001148

Primary

Chronic Success Rate

The primary effectiveness of the Blazer OI catheter will be evaluated by demonstrating that the proportion of subjects free from failure* in the investigational group is non-inferior to those in the control group.

*failure is defined as a randomized subject being an acute procedural failure, having more than one repeat procedure during the 90 day blanking period or having a documented symptomatic atrial fibrillation, atrial tachycardia, atrial fibrillation between 91 days and 12 months post-procedure.

Outcome Measures were not assessed for the non-randomized participants.

Posted

Count of Participants

Participants

Within 12 months of the index procedure

ID	Title	Description
OG000	Blazer Open-Irrigated Ablation Catheter	Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system Blazer Open-Irrigated Ablation Catheter (Boston Scientific)
OG001	Control	FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation. FDA Approved Open-Irrigated Ablation Catheter

Units

Secondary

Acute Success

Demonstration that the investigational group acute procedural success rate is non-inferior to that of the control group. Acute procedural success is defined as a subject that successfully had all clinically relevant veins electrically isolated, by demonstration of entrance block at a minimum and no evidence of exit conduction with the randomized investigational or control catheter only.

Outcome Measures were not assessed for the non-randomized participants.

Posted

Count of Participants

Participants

Acute- During Index Procedure, 20 minutes after confirmation of Pulmonary Vein Isolation

ID	Title	Description
OG000	Blazer Open-Irrigated Ablation Catheter	Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system Blazer Open-Irrigated Ablation Catheter (Boston Scientific)
OG001	Control	FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation. FDA Approved Open-Irrigated Ablation Catheter

Units	Counts

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
AV Fistula	Vascular disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0011 events1 affected167 at risk EG0021 events1 affected51 at risk EG0030 events0 affected1 at risk
Adverse medication reaction	General disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0010 events0 affected167 at risk EG0022 events2 affected51 at risk EG003
Alcohol dependency	General disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Arrhythmia (Ablation Procedure)	Cardiac disorders	Systematic Assessment	EG0003 events3 affected159 at risk EG0012 events2 affected167 at risk EG0021 events1 affected51 at risk EG003
Atrial fibrillation (AF)	Cardiac disorders	Systematic Assessment	EG00018 events18 affected159 at risk EG00128 events27 affected167 at risk EG0026 events6 affected51 at risk EG003
Atrial flutter (type 1 Isthmus Dependent)	Cardiac disorders	Systematic Assessment	EG0003 events3 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Atrial tachycardia	Cardiac disorders	Systematic Assessment	EG0004 events2 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Atypical Atrial Flutter	Cardiac disorders	Systematic Assessment	EG0006 events5 affected159 at risk EG0012 events2 affected167 at risk EG0021 events1 affected51 at risk EG003
Atypical atrial flutter	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Cancer	General disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0013 events3 affected167 at risk EG0020 events0 affected51 at risk EG003
Cardiac arrest	Cardiac disorders	Systematic Assessment	EG0002 events2 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Cardiac tamponade/perforation	Cardiac disorders	Systematic Assessment	EG0004 events4 affected159 at risk EG0013 events3 affected167 at risk EG0020 events0 affected51 at risk EG003
Cardiomyopathy	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Cerebrovascular accident (CVA)	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Chest pain	General disorders	Systematic Assessment	EG0003 events3 affected159 at risk EG0012 events2 affected167 at risk EG0021 events1 affected51 at risk EG003
Chest pain - Heart failure	Cardiac disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0010 events0 affected167 at risk EG0021 events1 affected51 at risk EG003
Coronary Artery Disease	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0012 events2 affected167 at risk EG0020 events0 affected51 at risk EG003
Dizziness	General disorders	Systematic Assessment	EG0005 events5 affected159 at risk EG0012 events2 affected167 at risk EG0020 events0 affected51 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0011 events1 affected167 at risk EG0021 events1 affected51 at risk EG003
Endocrine	Endocrine disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0011 events1 affected167 at risk EG0021 events1 affected51 at risk EG003
Fluid volume overload( i.e. diuresis, electrolyte imbalance) (Ablation Procedure)	General disorders	Systematic Assessment	EG0002 events2 affected159 at risk EG0010 events0 affected167 at risk EG0021 events1 affected51 at risk EG003
Gastrointestinal	Gastrointestinal disorders	Systematic Assessment	EG0005 events5 affected159 at risk EG0014 events4 affected167 at risk EG0023 events2 affected51 at risk EG003
Genitourinary	Renal and urinary disorders	Systematic Assessment	EG0009 events8 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Head, eyes, ears, nose, throat (HEENT)	General disorders	Systematic Assessment	EG0003 events3 affected159 at risk EG0012 events2 affected167 at risk EG0024 events3 affected51 at risk EG003
Heart failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Heart failure symptoms - Unspecified	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0022 events1 affected51 at risk EG003
Hematoma (Ablation Procedure)	Vascular disorders	Systematic Assessment	EG0002 events2 affected159 at risk EG0011 events1 affected167 at risk EG0021 events1 affected51 at risk EG003
Hiccups	General disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0010 events0 affected167 at risk EG0021 events1 affected51 at risk EG003
Hypertension	Cardiac disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Hypotension	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
IV infiltrate	General disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Multiple heart failure symptoms	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0022 events1 affected51 at risk EG003
Multiple symptoms	General disorders	Systematic Assessment	EG0002 events1 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Musculoskeletal	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0009 events9 affected159 at risk EG0013 events3 affected167 at risk EG0022 events2 affected51 at risk EG003
Myocardial infarction	Cardiac disorders	Systematic Assessment	EG0002 events2 affected159 at risk EG0010 events0 affected167 at risk EG0021 events1 affected51 at risk EG003
Other SVT (AVRT, AVNRT, EAT etc.	Cardiac disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Palpitations	Cardiac disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0011 events1 affected167 at risk EG0021 events1 affected51 at risk EG003
Pericardial Effusion (Ablation Procedure)	Cardiac disorders	Systematic Assessment	EG0002 events2 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Pericarditis (Ablation Procedure)	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0022 events2 affected51 at risk EG003
Premature atrial contractions (PAC)	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Psychological	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Pulmonary	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00012 events11 affected159 at risk EG0018 events7 affected167 at risk EG0021 events1 affected51 at risk EG003
Pulmonary Vein Stenosis - Significant (>70%)	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Pulmonary edema - Heart failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Pulmonary embolism (PE)	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Rectus sheath hematoma	Vascular disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Renal	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0022 events2 affected51 at risk EG003
Renal insufficiency - Heart failure	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0010 events0 affected167 at risk EG0021 events1 affected51 at risk EG003
Sanguineous drainage	Infections and infestations	Systematic Assessment	EG0000 events0 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Sinus bradycardia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Syncope	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Systemic infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected159 at risk EG0012 events2 affected167 at risk EG0020 events0 affected51 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
1st degree AV block	Cardiac disorders	Systematic Assessment	EG0007 events7 affected159 at risk EG0015 events5 affected167 at risk EG0020 events0 affected51 at risk EG0030 events0 affected1 at risk
2nd degree AV block	Cardiac disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
AV Fistula	Vascular disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0010 events0 affected167 at risk EG0021 events1 affected51 at risk EG003
Abnormal laboratory values	General disorders	Systematic Assessment	EG0006 events6 affected159 at risk EG0011 events1 affected167 at risk EG0022 events2 affected51 at risk EG003
Adverse medication reaction	General disorders	Systematic Assessment	EG00011 events9 affected159 at risk EG0018 events8 affected167 at risk EG0023 events3 affected51 at risk EG003
Allergic reaction	General disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Allergic reaction (Ablation Procedure)	General disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Anesthesia/Sedation related complication (Ablation Procedure)	General disorders	Systematic Assessment	EG0003 events1 affected159 at risk EG0010 events0 affected167 at risk EG0021 events1 affected51 at risk EG003
Angina	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Aortic root atheromatosis	Cardiac disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0010 events0 affected167 at risk EG0021 events1 affected51 at risk EG003
Arrhythmia (Ablation Procedure)	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0021 events1 affected51 at risk EG003
Arterial/Venous Thromboembolic Events	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Atrial fibrillation (AF)	Cardiac disorders	Systematic Assessment	EG00022 events22 affected159 at risk EG00133 events32 affected167 at risk EG00212 events12 affected51 at risk EG003
Atrial flutter (type 1 Isthmus Dependent)	Cardiac disorders	Systematic Assessment	EG0003 events3 affected159 at risk EG0012 events2 affected167 at risk EG0022 events2 affected51 at risk EG003
Atrial tachycardia	Cardiac disorders	Systematic Assessment	EG00011 events11 affected159 at risk EG0016 events6 affected167 at risk EG0020 events0 affected51 at risk EG003
Atypical Atrial Flutter	Cardiac disorders	Systematic Assessment	EG0003 events3 affected159 at risk EG0013 events3 affected167 at risk EG0020 events0 affected51 at risk EG003
Back discomfort	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0011 events1 affected167 at risk EG0021 events1 affected51 at risk EG003
Bradycardia with pauses	Cardiac disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0010 events0 affected167 at risk EG0021 events1 affected51 at risk EG003
Breathing difficulties	Cardiac disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Brugada syndrome	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Cancer	General disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Chest pain	Cardiac disorders	Systematic Assessment	EG00013 events12 affected159 at risk EG0019 events6 affected167 at risk EG0023 events3 affected51 at risk EG003
Chest pain - Ischemic	Cardiac disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0010 events0 affected167 at risk EG0021 events1 affected51 at risk EG003
Cirrhosis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0010 events0 affected167 at risk EG0021 events1 affected51 at risk EG003
Cyst on ascending aorta	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Dehydration	General disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Depression	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0010 events0 affected167 at risk EG0021 events1 affected51 at risk EG003
Difficulty sleeping	General disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Dizziness	General disorders	Systematic Assessment	EG0002 events2 affected159 at risk EG0017 events7 affected167 at risk EG0022 events2 affected51 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0008 events8 affected159 at risk EG0011 events1 affected167 at risk EG0021 events1 affected51 at risk EG003
Dyspnea on exertion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Edema (Ablation Procedure)	Vascular disorders	Systematic Assessment	EG0002 events2 affected159 at risk EG0010 events0 affected167 at risk EG0021 events1 affected51 at risk EG003
Endocrine	Endocrine disorders	Systematic Assessment	EG0002 events2 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Epistaxis	General disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Exacerbation of existing condition (Ablation Procedure)	General disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0010 events0 affected167 at risk EG0021 events1 affected51 at risk EG003
Fatigue	General disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0021 events1 affected51 at risk EG003
Fever	General disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Fluid retention	General disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0011 events1 affected167 at risk EG0021 events1 affected51 at risk EG003
Gastrointestinal	Gastrointestinal disorders	Systematic Assessment	EG00010 events9 affected159 at risk EG00112 events9 affected167 at risk EG0023 events3 affected51 at risk EG003
Gastroparesis (Ablation Procedure)	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Genitourinary	Renal and urinary disorders	Systematic Assessment	EG00010 events10 affected159 at risk EG00110 events10 affected167 at risk EG0024 events4 affected51 at risk EG003
Groin bleed (Ablation Procedure)	Vascular disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0010 events0 affected167 at risk EG0021 events1 affected51 at risk EG003
Groin pain	General disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Head, eyes, ears, nose, throat (HEENT)	General disorders	Systematic Assessment	EG00013 events13 affected159 at risk EG00114 events12 affected167 at risk EG0023 events3 affected51 at risk EG003
Heart failure symptoms - Unspecified	Cardiac disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Hematological	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Hematoma (Ablation Procedure)	Vascular disorders	Systematic Assessment	EG0007 events7 affected159 at risk EG0014 events4 affected167 at risk EG0024 events4 affected51 at risk EG003
Hemorrhage (Ablation Procedure)	General disorders	Systematic Assessment	EG0002 events2 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Hypertension	Cardiac disorders	Systematic Assessment	EG0006 events5 affected159 at risk EG0013 events3 affected167 at risk EG0021 events1 affected51 at risk EG003
Hypotension	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Hypotension (Ablation Procedure)	Cardiac disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Increased GERD	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0010 events0 affected167 at risk EG0021 events1 affected51 at risk EG003
Integumentary	General disorders	Systematic Assessment	EG0005 events5 affected159 at risk EG0013 events3 affected167 at risk EG0021 events1 affected51 at risk EG003
Intracardiac thrombus with no thromboembolic event	Cardiac disorders	Systematic Assessment	EG0002 events2 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Intraventricular conduction delay	Cardiac disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0010 events0 affected167 at risk EG0021 events1 affected51 at risk EG003
Junctional ectopic rhythm	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0021 events1 affected51 at risk EG003
Long QT	Cardiac disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Lyme disease	Infections and infestations	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Multiple heart failure symptoms	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Musculoskeletal	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0007 events7 affected159 at risk EG0018 events8 affected167 at risk EG0022 events2 affected51 at risk EG003
Neurological	Nervous system disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0015 events5 affected167 at risk EG0021 events1 affected51 at risk EG003
Non-toxic LLE cellulitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Nonsustained ventricular tachycardia (NSVT)	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Other SVT (AVRT, AVNRT, EAT etc.	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0011 events1 affected167 at risk EG0023 events3 affected51 at risk EG003
Pain neuromuscular/non cardiovascular (Ablation Procedure)	Nervous system disorders	Systematic Assessment	EG0002 events2 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Palpitations	Cardiac disorders	Systematic Assessment	EG0004 events4 affected159 at risk EG0017 events6 affected167 at risk EG0022 events2 affected51 at risk EG003
Pericardial Effusion (Ablation Procedure)	Cardiac disorders	Systematic Assessment	EG0003 events3 affected159 at risk EG0013 events3 affected167 at risk EG0021 events1 affected51 at risk EG003
Pericardial effusion	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Pericardial effusion - Unrelated to procedure	Cardiac disorders	Systematic Assessment	EG0002 events2 affected159 at risk EG0010 events0 affected167 at risk EG0021 events1 affected51 at risk EG003
Peripheral edema	Vascular disorders	Systematic Assessment	EG0003 events3 affected159 at risk EG0010 events0 affected167 at risk EG0021 events1 affected51 at risk EG003
Peripheral edema - Heart failure	Vascular disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Peripheral neuropathy	Nervous system disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Physical trauma	General disorders	Systematic Assessment	EG0003 events3 affected159 at risk EG0012 events2 affected167 at risk EG0021 events1 affected51 at risk EG003
Pleuritis (Ablation Procedure)	Cardiac disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0011 events1 affected167 at risk EG0022 events2 affected51 at risk EG003
Premature atrial contractions (PAC)	Cardiac disorders	Systematic Assessment	EG0005 events5 affected159 at risk EG0012 events2 affected167 at risk EG0021 events1 affected51 at risk EG003
Premature ventricular contractions (PVC)	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0013 events3 affected167 at risk EG0021 events1 affected51 at risk EG003
Pseudoaneurysm	Vascular disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0010 events0 affected167 at risk EG0021 events1 affected51 at risk EG003
Psychological	Psychiatric disorders	Systematic Assessment	EG0002 events2 affected159 at risk EG0012 events2 affected167 at risk EG0020 events0 affected51 at risk EG003
Pulmonary	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00014 events11 affected159 at risk EG0019 events9 affected167 at risk EG0022 events1 affected51 at risk EG003
Pulmonary Vein Stenosis - Mild or Moderate (<70%)	Cardiac disorders	Systematic Assessment	EG0004 events4 affected159 at risk EG0010 events0 affected167 at risk EG0022 events2 affected51 at risk EG003
Pulmonary Vein Stenosis - Significant (>70%)	Cardiac disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0012 events2 affected167 at risk EG0020 events0 affected51 at risk EG003
Renal	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0021 events1 affected51 at risk EG003
Right bundle branch block	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0021 events1 affected51 at risk EG003
Sinus arrhythmia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Sinus bradycardia	Cardiac disorders	Systematic Assessment	EG0005 events5 affected159 at risk EG0016 events6 affected167 at risk EG0022 events2 affected51 at risk EG003
Sinus tachycardia	Cardiac disorders	Systematic Assessment	EG0008 events8 affected159 at risk EG0014 events4 affected167 at risk EG0020 events0 affected51 at risk EG003
Sore throat	General disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0013 events3 affected167 at risk EG0021 events1 affected51 at risk EG003
Swollen groin	Vascular disorders	Systematic Assessment	EG0002 events2 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Syncope	Cardiac disorders	Systematic Assessment	EG0002 events2 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Tachycardia (Ablation Procedure)	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Thrombus (No embolism) (Ablation Procedure)	Cardiac disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0010 events0 affected167 at risk EG0021 events1 affected51 at risk EG003
Typical atrial flutter	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Vagal denervation symptoms	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected159 at risk EG0011 events1 affected167 at risk EG0020 events0 affected51 at risk EG003
Ventricular tachycardia (VT)	Cardiac disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003
Visual Blurring/Disturbances (Ablation Procedure)	Eye disorders	Systematic Assessment	EG0001 events1 affected159 at risk EG0010 events0 affected167 at risk EG0020 events0 affected51 at risk EG003

ID	Title	Description
BG000	Blazer Open-Irrigated Ablation Catheter	Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system Blazer Open-Irrigated Ablation Catheter (Boston Scientific)
BG001	Control	FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation. FDA Approved Open-Irrigated Ablation Catheter
BG002	Blazer Open-Irrigated Ablation Catheter Roll-In	Blazer Open-Irrigated Ablation Catheter Roll-In Subjects (Not randomized)
BG003	Control Roll-In	Non-Randomized Subjects treated with an FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation. FDA Approved Open-Irrigated Ablation Catheter
BG004	Total	Total of all reporting groups

ID	Term
D001281	Atrial Fibrillation
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Blazer Open-Irrigated Ablation Catheter Randomized	Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system Blazer Open-Irrigated Ablation Catheter (Boston Scientific)	1	159	66	159	104	159
EG001	FDA Approved Open-Irrigated Ablation Catheter Randomized	FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation. FDA Approved Open-Irrigated Ablation Catheter	1	167	65	167	95	167
EG002	Blazer Open-Irrigated Ablation Catheter Roll-In	Roll-In Cases for Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system Blazer Open-Irrigated Ablation Catheter (Boston Scientific)	0	51	19	51	33	51
EG003	FDA Approved Open-Irrigated Ablation Catheter Roll-In	Roll-In Cases for FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation. FDA Approved Open-Irrigated Ablation Catheter	0	1	0	1	0	1