Paroxysmal Atrial Fibrillation
Conditions
Brief summary
The purpose of this registry is to provide additional corroborative short-term safety and long-term safety data for the NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL catheters in the treatment of symptomatic Paroxysmal Atrial Fibrillation (PAF).
Detailed description
This registry is a prospective, multi-center, non-randomized post approval evaluation comprised of two (2) registry arms with independent hypotheses. The registry arms are defined as; Arm 1) physicians who perform greater than or equal to 50 atrial fibrillation ablation procedures per year and Arm 2) physicians who perform less than 50 atrial fibrillation ablation procedures per year. Subjects with drug refractory recurrent symptomatic PAF will be considered for this post approval registry. This registry will be conducted at up to 40 centers in a minimum of 381 evaluable subjects. The devices are currently FDA approved for commercial distribution under PMA #P030031/S11.
Interventions
PROCEDUREAtrial fibrillation ablation
Radiofrequency ablation
Sponsors
Biosense Webster, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Subjects Experiencing Primary Adverse Events Within Seven Days of the Ablation Procedure. | Seven days post 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Experienced Serious Adverse Events. | First study day to 5 year post-ablation | 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). |
Participant flow
Recruitment details
The first subject was enrolled on September 29, 2009. Subject enrollment was completed and closed on October 01, 2013 after reaching a total of 437 enrolled (381 evaluable) subjects. The study is still ongoing. This report covers data up to the data download of June 23, 2015.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 128 |
| Less-experienced Physicians Subjects were enrolled into sites where the primary investigators were less-experienced physicians (LEP). Those physicians were prospectively classified into the LEP group if he or she had performed less than or equal to 50 atrial fibrillation (AF) ablation procedures per year. | 292 |
| Total | 420 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Early Termination, non-study arrhythmia | 1 | 6 |
| Overall Study | Lost to Follow-up | 4 | 10 |
| Overall Study | Not completed | 44 | 168 |
| Overall Study | Withdrawal by Subject | 4 | 6 |
Baseline characteristics
| Characteristic | Total | More-experienced Physicians | Less-experienced Physicians |
|---|---|---|---|
| Age, Continuous | 60.5 years STANDARD_DEVIATION 9.5 | 61.0 years STANDARD_DEVIATION 9.6 | 60.3 years STANDARD_DEVIATION 9.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 2 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 410 Participants | 126 Participants | 284 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 1 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) White | 387 Participants | 125 Participants | 262 Participants |
| Region of Enrollment United States | 420 participants | 128 participants | 292 participants |
| Sex: Female, Male Female | 146 Participants | 44 Participants | 102 Participants |
| Sex: Female, Male Male | 274 Participants | 84 Participants | 190 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 78 / 125 | 168 / 282 |
| serious Total, serious adverse events | 41 / 125 | 95 / 282 |
Outcome results
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.
Time frame: Seven days post ablation procedure
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| More-experienced Physicians | The Percentage of Subjects Experiencing Primary Adverse Events Within Seven Days of the Ablation Procedure. | 3.2 percentage of participants |
| Less-experienced Physicians | The Percentage of Subjects Experiencing Primary Adverse Events Within Seven Days of the Ablation Procedure. | 6.4 percentage of participants |
Secondary
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).
Time frame: First study day to 5 year post-ablation
Population: Safety population, which is defined as those subjects who underwent study catheter insertion. However subject LUC-030, who experienced one SAE, was excluded from this analysis since the subject discontinued prior to RF ablation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| More-experienced Physicians | Percentage of Subjects Experienced Serious Adverse Events. | 1 to 30 days post-ablation | 6.4 percentage of participants |
| More-experienced Physicians | Percentage of Subjects Experienced Serious Adverse Events. | 31 days to 365 days post-ablation | 11.2 percentage of participants |
| More-experienced Physicians | Percentage of Subjects Experienced Serious Adverse Events. | 366 to 730 days post-ablation | 14.9 percentage of participants |
| More-experienced Physicians | Percentage of Subjects Experienced Serious Adverse Events. | More than 730 days post-ablation | 11.0 percentage of participants |
| Less-experienced Physicians | Percentage of Subjects Experienced Serious Adverse Events. | More than 730 days post-ablation | 11.1 percentage of participants |
| Less-experienced Physicians | Percentage of Subjects Experienced Serious Adverse Events. | 1 to 30 days post-ablation | 12.1 percentage of participants |
| Less-experienced Physicians | Percentage of Subjects Experienced Serious Adverse Events. | 366 to 730 days post-ablation | 7.4 percentage of participants |
| Less-experienced Physicians | Percentage of Subjects Experienced Serious Adverse Events. | 31 days to 365 days post-ablation | 14.5 percentage of participants |