NAVISTAR® THERMOCOOL® Catheter Post Approval Registry | NCT00964392

NCT00964392

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
More-Experienced Physicians (MEP)	Experimental	Physicians who perform greater than or equal to 50 atrial fibrillation ablation procedures per year.	Procedure: Atrial fibrillation ablation
Less-Experienced Physicians (LEP)	Experimental	Physicians who perform less than 50 atrial fibrillation ablation procedures per year.	Procedure: Atrial fibrillation ablation

Name	Type	Description	Arm Group Labels	Other Names
Atrial fibrillation ablation	Procedure	Radiofrequency ablation	Less-Experienced Physicians (LEP) More-Experienced Physicians (MEP)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Percentage of Subjects Experiencing Primary Adverse Events Within Seven Days of the Ablation Procedure.	The primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient ischemic attack (TIA), Stroke/Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac tamponade, Pericardial effusion, Pneumothorax, Atrial perforation, Vascular access complications, Pulmonary edema, Hospitalization (including initial and prolonged, excluding those hospitalizations solely due to pre-existing arrhythmia recurrence), Heart block. Pulmonary vein stenosis (defined as ≥70% diameter reduction) and atrio-esophageal fistula occurring more than 7 days post-procedure shall be deemed a Primary AE. The primary endpoint for the Post-Approval Registry is a comparison of the 7-day primary AE rate against a performance criterion of 16 %. The 16% performance criterion is based on literature data and discussion with the FDA per IDE G030236.	Seven days post ablation procedure

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Subjects Experienced Serious Adverse Events.	The occurrence of serious adverse events (SAE) was used to provide the prospective long-term safety data. The SAEs are summarized by the following time periods: 0 to 30 days post-ablation, 31 days to 365 post-ablation, 366 to 730 days post-ablation, and more than 730 days post-ablation. One subject might have experienced SAEs in more than one time periods. This report covers the SAEs occurred from September 29, 2009 (first patient enrolled) to June 23, 2015 (data download date for this report).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Candidates for this registry must meet ALL of the following criteria:

Patients with drug refractory recurrent symptomatic PAF who have had three (3) AF episodes in the six (6) months prior to enrollment and one AF episode documented within the one (1) year prior to enrollment. Documentation may include electrocardiogram (ECG), transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip.
Failure of at least one AAD for AF (class I or III or AV nodal blocking agent such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic PAF, or intolerable side effects.
Age 18 years or older.
Able and willing to comply with all pre-, post- and follow-up testing and requirements.
Signed Patient Informed Consent Form.

Exclusion Criteria:

Candidates will be excluded from the registry if any of the following conditions apply:

Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
AF episodes that last longer than 30 days and are terminated via cardioversion.
CABG procedure within the last six (6) months.
Awaiting cardiac transplantation or other cardiac surgery.
Documented left atrial thrombus on imaging (i.e., TEE, ICE, CT, or MRA).
History of a documented thromboembolic event within the past one (1) year.
Diagnosed atrial myxoma.
Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this registry.
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.
Uncontrolled heart failure.
Myocardial infarction within the previous two (2) months.
History of blood clotting or bleeding abnormalities.
Contraindication to anticoagulation (i.e. heparin or warfarin).
Life expectancy less than 12 months.
Enrollment in an investigational study evaluating another device or drug.
Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.

ID	Title	Description
FG000	More-Experienced Physicians (MEP)	MEP are defined as those who have performed greater than 50 AF ablation cases per year.
FG001	Less-Experienced Physicians (LEP)	LEP are defined as those who have performed less than or equal to 50 AF ablations per year.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	More-experienced Physicians	Subjects were enrolled into sites where the primary investigators were more-experienced physicians (MEP). Those physicians were prospectively classified into the MEP group if he or she had performed greater than 50 atrial fibrillation (AF) ablation procedures per year.
BG001

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

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 Subjects Experiencing Primary Adverse Events Within Seven Days of the Ablation Procedure.	The primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient ischemic attack (TIA), Stroke/Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac tamponade, Pericardial effusion, Pneumothorax, Atrial perforation, Vascular access complications, Pulmonary edema, Hospitalization (including initial and prolonged, excluding those hospitalizations solely due to pre-existing arrhythmia recurrence), Heart block. Pulmonary vein stenosis (defined as ≥70% diameter reduction) and atrio-esophageal fistula occurring more than 7 days post-procedure shall be deemed a Primary AE. The primary endpoint for the Post-Approval Registry is a comparison of the 7-day primary AE rate against a performance criterion of 16 %. The 16% performance criterion is based on literature data and discussion with the FDA per IDE G030236.	Safety population, which is defined as those subjects who underwent study catheter insertion. However subject LUC-030, who experienced one primary AE, was excluded from this analysis since the subject discontinued prior to RF ablation.	Posted		Number	95% Confidence Interval	percentage of participants		Seven days post ablation procedure

Adverse Events Module

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	More-experienced Physicians	Subjects were enrolled into sites where the primary investigators were more-experienced physicians (MEP). Those physicians were prospectively classified into the MEP group if he or she had performed greater than 50 atrial fibrillation (AF) ablation procedures per year.

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes