Irrigated Ablation System Evaluation for Atrial Fibrillat... | NCT01056328

Status Module

Label	Type	Description	Intervention Names
St. Jude Medical Cardiac Ablation System	Experimental		Device: SJM Irrigated Cardiac Ablation System
FDA approved Open Irrigated Radio Frequency Ablation System	Active Comparator		Device: FDA approved Open Irrigated RF Ablation System

Name	Type	Description	Arm Group Labels	Other Names
SJM Irrigated Cardiac Ablation System	Device	Irrigated ablation catheter	St. Jude Medical Cardiac Ablation System

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Confirmation of Entrance Block in the Pulmonary Veins		20 minutes after initial isolation
Incidence of Adverse Events Included in the Pre-specified Composite	Atrial perforation, atrio-esophageal fistula, cardiac tamponade, cerebrovascular accident, death, diaphragmatic paralysis, hospitalization, myocardial infarction, pericaridal effusion, pericarditis, pulumonary edema, pulmonary vein stenosis, thromboembolism, transient ischemic attack, and vascular access complications.	7 days
Incidence of Adverse Events Included in the Pre-specified Composite.		12 months

Secondary Outcomes

Measure	Description	Time Frame
Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period		12 months
Early Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 years or older
Signed Patient Informed Consent Form
Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Failure of at least one anti-arrhythmic medication (AAD) for paroxysmal atrial fibrillation* [class I or III, or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)] as evidenced by recurrent symptomatic paroxysmal atrial fibrillation*, or intolerable side effects due to AAD
Subjects with symptomatic paroxysmal atrial fibrillation (PAF)*
- PAF is defined as recurrent atrial fibrillation (AF) that terminates spontaneously within seven days.

Exclusion Criteria:

Atrial fibrillation (AF) secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
Previous ablation for AF
History of any valvular cardiac surgical procedure
Coronary artery bypass grafting (CABG) procedure within the last six months
Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
Left atrial thrombus
History of a documented thromboembolic event within the past one (1) year
Diagnosed atrial myxoma
An implanted implantable cardioverter defibrillator (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 two months
Left ventricular ejection fraction (LVEF) <40% as determined by pre-procedure transthoracic echocardiogram (TTE)
History of blood clotting or bleeding abnormalities
Contraindication to anticoagulation (i.e. heparin or warfarin)
Contraindication to computed tomography/magnetic resonance angiography (CT/MRA) procedure
Life expectancy less than 12 months
Enrollment in an investigational study evaluating another device or drug
Uncontrolled heart failure or New York Heart Association (NYHA) class III or IV heart failure
An 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 as determined by pre-procedure TTE

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
Arizona Arrhythmia Consultants/Scottsdale Healthcare

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	SJM Cardiac Ablation System	SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
FG001	FDA Approved Open Irriagated RF Ablation System	FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

ID	Title	Description
BG000	SJM Cardiac Ablation System	SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
BG001	FDA Approved Open Irriagated RF Ablation System	FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000164 BG001160 BG002324

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00058.5± 12.4 BG00160.6± 9.7 BG00259.5± 11.2

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00059 BG00166 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000149 BG001149 BG002

Type

Title

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

Confirmation of Entrance Block in the Pulmonary Veins

Posted

Number

participants

20 minutes after initial isolation

ID	Title	Description
OG000	SJM Cardiac Ablation System	SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
OG001	FDA Approved Open Irriagated RF Ablation System	FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter

Units	Counts
Participants	OG000164 OG001160

Title

Denominators

Categories

Title	Measurements
	OG000159 OG001157

Primary

Incidence of Adverse Events Included in the Pre-specified Composite

Atrial perforation, atrio-esophageal fistula, cardiac tamponade, cerebrovascular accident, death, diaphragmatic paralysis, hospitalization, myocardial infarction, pericaridal effusion, pericarditis, pulumonary edema, pulmonary vein stenosis, thromboembolism, transient ischemic attack, and vascular access complications.

Posted

Number

participants

7 days

ID	Title	Description
OG000	St Jude Medical (SJM) Cardiac Ablation System	SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
OG001	FDA Approved Open Irrigated RF Ablation System	FDA approved Open Irrigated Radio Frequency (RF) Ablation System: Irrigated ablation catheter

Units	Counts
Participants	OG000

Primary

Incidence of Adverse Events Included in the Pre-specified Composite.

Posted

Number

participants

12 months

ID	Title	Description
OG000	SJM Cardiac Ablation System	SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
OG001	FDA Approved Open Irriagated RF Ablation System	FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter

Units	Counts
Participants	OG000134

Secondary

Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period

Posted

Number

participants

12 months

ID	Title	Description
OG000	SJM Cardiac Ablation System	SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
OG001	FDA Approved Open Irrigated RF Ablation System	FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter

Units	Counts
Participants	OG000

Secondary

Early Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs

Early onset (within 90 days) of Serious Adverse Events (SAE)/Non-serious Adverse Events (AEs) and late onset (after 90 days) Serious Adverse Events (SAEs)

Posted

Number

participants

12 months

ID	Title	Description
OG000	SJM Cardiac Ablation System	SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
OG001	FDA Approved Open Irriagated RF Ablation System	FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Pulmonary vein stenosis	Cardiac disorders	Systematic Assessment	EG0005 events5 affected164 at risk EG0017 events7 affected160 at risk
Cardiac perforation	Cardiac disorders	Systematic Assessment	EG0001 events1 affected164 at risk EG0011 events1 affected160 at risk
Chest and back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected160 at risk
Heart failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected160 at risk
Hypotension	Cardiac disorders	Systematic Assessment	EG0002 events2 affected164 at risk EG0010 events0 affected160 at risk
Local hematoma	Vascular disorders	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected160 at risk
Pericardial effusion	Cardiac disorders	Systematic Assessment	EG0002 events2 affected164 at risk EG0010 events0 affected160 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected160 at risk
Pulmonary edema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected164 at risk EG0010 events0 affected160 at risk
Arrhythmia	Cardiac disorders	Systematic Assessment	EG0002 events2 affected164 at risk EG0010 events0 affected160 at risk
Coronary artery spasm	Cardiac disorders	Systematic Assessment	EG0000 events0 affected164 at risk EG0012 events2 affected160 at risk
Pericarditis	Cardiac disorders	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected160 at risk
Other	General disorders	Systematic Assessment	EG0008 events8 affected164 at risk EG0016 events6 affected160 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Chest and back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected164 at risk EG0011 events1 affected160 at risk
Hypotension	Cardiac disorders	Systematic Assessment	EG0001 events1 affected164 at risk EG0011 events1 affected160 at risk
Infection	Infections and infestations	Systematic Assessment	EG0002 events2 affected164 at risk EG0010 events0 affected160 at risk
Local hematoma	Vascular disorders	Systematic Assessment	EG0003 events3 affected164 at risk EG0012 events2 affected160 at risk
Pericarditis	Cardiac disorders	Systematic Assessment	EG0001 events1 affected164 at risk EG0010 events0 affected160 at risk
Pseudoaneurysm	Vascular disorders	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected160 at risk
Skin burn	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected164 at risk EG0011 events1 affected160 at risk
Other	General disorders	Systematic Assessment	EG0006 events6 affected164 at risk EG0014 events4 affected160 at risk

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
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	SJM Cardiac Ablation System	SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter			26	164	14	164
EG001	FDA Approved Open Irrigated RF Ablation System	FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter			16	160	10	160