NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Abl... | NCT00116428

Status Module

Description Module

Label	Type	Description	Intervention Names
NAVISTAR® THERMOCOOL® Catheter	Experimental		Device: NAVISTAR® THERMOCOOL® Catheter
Antiarrhythmic drug	Active Comparator		Drug: Antiarrhythmic drug

Name	Type	Description	Arm Group Labels	Other Names
NAVISTAR® THERMOCOOL® Catheter	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF)	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.	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.
The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Serious Catheter-related Adverse Events	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.	Within 7 Days of Ablation Procedure

Secondary Outcomes

Measure	Description	Time Frame
The Percentage of Subjects Who Achieved Acute Success.	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.

Eligibility Module

Eligibility Criteria

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

Name	Affiliation	Role
David Wilber, MD	Loyola University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Marin General Hospital		Greenbrae	California	94904	United States
Florida Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20103757	Result	Wilber DJ, Pappone C, Neuzil P, De Paola A, Marchlinski F, Natale A, Macle L, Daoud EG, Calkins H, Hall B, Reddy V, Augello G, Reynolds MR, Vinekar C, Liu CY, Berry SM, Berry DA; ThermoCool AF Trial Investigators. Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial. JAMA. 2010 Jan 27;303(4):333-40. doi: 10.1001/jama.2009.2029.
20940250

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	NAVISTAR® THERMOCOOL® Catheter	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	NAVISTAR® THERMOCOOL® Catheter	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.
BG001	Antiarrhythmic Drug	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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000106 BG00161 BG002167

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
	BG00055.5± 9.3 BG00156.1± 12.8 BG00255.7± 10.7

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00033 BG00123 BG002

Race/Ethnicity, Customized

Ethnicity

Number

Participants

Title

Denominators

Categories

Hispanic

Title	Measurements
	BG0001 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Brazil

Title	Measurements
	BG0007 BG0015 BG002

Number of documented symptomatic Atrial Fibrillation episodes

Number of symptomatic Atrial Fibrillation episodes during the last six months prior to study enrollment.

Mean

Standard Deviation

Number of episodes

Title

Denominators

Categories

Title	Measurements
	BG00062.3± 89.2 BG001

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

The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF)

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.

Posted

Number

Percentage of participants

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.

ID	Title	Description
OG000	NAVISTAR® THERMOCOOL® Catheter	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.
OG001	Antiarrhythmic Drug	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.

Units	Counts
Participants	OG000106 OG00161

Title

Denominators

Categories

Title	Measurements
	OG00066 OG00116

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The study null hypothesis is that the chronic success rates for the THERMOCOOL and AAD groups are equal.	Log Rank		<0.001							95							Superiority or Other

Primary

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

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.

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.

Posted

Number

Percentage of Participants

Within 7 Days of Ablation Procedure

ID	Title	Description
OG000	NAVISTAR® THERMOCOOL® Catheter	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.
OG001	Antiarrhythmic Drug	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.

Secondary

The Percentage of Subjects Who Achieved Acute Success.

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.

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

Posted

Number

Percentage of participants

90 days post study procedure

ID	Title	Description
OG000	NAVISTAR® THERMOCOOL® Catheter	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.
OG001	Antiarrhythmic Drug	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.

Secondary

Percentage of Subjects Who Experienced Atrial Fibrillation Recurrence During the Two-year Follow up.

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

Subjects who completed two years follow up

Posted

Number

Percentage of Participants

During the two years of post procedure

ID	Title	Description
OG000	NAVISTAR® THERMOCOOL® Catheter	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.
OG001	Antiarrhythmic Drug Subjects Undergoing Ablation	Control Group Subjects underwent a study ablation procedure after failing the effectiveness endpoint.
OG002	Antiarrhythmic Drug	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.

Secondary

Percentage of Subjects Responded to Each of the Four Health Status Categories.

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

Subjects who completed the two-year health survey.

Posted

Number

Percentage of Participants

During the two years of post procedure

ID	Title	Description
OG000	NAVISTAR® THERMOCOOL® Catheter	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.
OG001	Antiarrhythmic Drug Subjects Undergoing Ablation	Control subjects underwent a study ablation procedure after failing the effectiveness endpoint.
OG002	Antiarrhythmic Drug	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.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	NAVISTAR® THERMOCOOL® Catheter	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.			25	139	23	139
EG001	Antiarrhythmic Drug	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.			0	25	0	25

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Death	General disorders	Systematic Assessment	EG0002 events2 affected139 at risk EG0010 events0 affected25 at risk
Pericarditis	Cardiac disorders	Systematic Assessment	EG0001 events1 affected139 at risk EG0010 events0 affected25 at risk
Pericardial Effusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected139 at risk EG0010 events0 affected25 at risk
Vascular Access Complication	Vascular disorders	Systematic Assessment	EG0005 events5 affected139 at risk EG0010 events0 affected25 at risk
Pulmonary Edema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected139 at risk EG0010 events0 affected25 at risk
Hospitalization	Investigations	Systematic Assessment	EG0007 events7 affected139 at risk EG0010 events0 affected25 at risk
Tearing of atrial septum	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected139 at risk EG0010 events0 affected25 at risk
Urinary Tract Infection	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected139 at risk EG0010 events0 affected25 at risk
Hemoptysis/Right Kidney Stone	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected139 at risk EG0010 events0 affected25 at risk
Neoplasm/Kidney Nodule	Renal and urinary disorders	Systematic Assessment	EG0002 events2 affected139 at risk EG0010 events0 affected25 at risk
Emergency Department Visit	Cardiac disorders	Systematic Assessment	EG0002 events2 affected139 at risk EG0010 events0 affected25 at risk
Hematuria	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected139 at risk EG0010 events0 affected25 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Chest Pain	General disorders	Systematic Assessment	EG0002 events2 affected139 at risk EG0010 events0 affected25 at risk
Back pain	General disorders	Systematic Assessment	EG0003 events3 affected139 at risk EG0010 events0 affected25 at risk
Hematoma	Blood and lymphatic system disorders	Systematic Assessment	EG0002 events2 affected139 at risk EG0010 events0 affected25 at risk
Hematuria	Renal and urinary disorders	Systematic Assessment	EG0003 events3 affected139 at risk EG0010 events0 affected25 at risk
Nausea, Vomiting/Rigors	Gastrointestinal disorders	Systematic Assessment	EG0006 events2 affected139 at risk EG0010 events0 affected25 at risk
Neurologic Side Effects	Nervous system disorders	Systematic Assessment	EG0003 events3 affected139 at risk EG0010 events0 affected25 at risk
Pericardial Effusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected139 at risk EG0010 events0 affected25 at risk
Hematoma/Bleeding/groin pain	Blood and lymphatic system disorders	Systematic Assessment	EG0005 events3 affected139 at risk EG0010 events0 affected25 at risk
Shortness of Breath	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 events3 affected139 at risk EG0010 events0 affected25 at risk

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

ID	Term
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D002317	Cardiovascular Agents
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses