Arrhythmia, Atrial Fibrillation, Heart Diseases
Conditions
Keywords
Atrial Fibrillation, Paroxysmal Atrial Fibrillation
Brief summary
The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL® SMARTTOUCH™ Catheters with Contact Force Sensing Capability in the treatment of drug refractory symptomatic paroxysmal Atrial Fibrillation (AF) during standard electrophysiology mapping and RF procedures.
Interventions
AF Ablation
Sponsors
Biosense Webster, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have had at least 3 atrial fibrillation episodes within 6 months of this study * Have failed at least one antiarrhythmic drug shown by repeated atrial fibrillation episodes * 18 years of age or older
Exclusion criteria
* Have had previous ablation for atrial fibrillation * Have take amiodarone within 6 months of this study * Have had any heart surgery within the last 60 days * Have had a heart attack within the last 60 days * Females who are pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Rate of Subjects Who Were Free From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 12-month Follow-up | 12-months | The primary effectiveness endpoint for this study will be freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up (includes a three month blanking period). |
| Incidence of Early Onset (Within 7 Days of the AF Ablation Procedure) Primary Adverse Events. | 7 days of the AF ablation procedure | 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 (initial and prolonged), and Heart block. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Acute Success | End of procedure | Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV). |
Participant flow
Recruitment details
The first subject was enrolled on June 02, 2011. Twenty-one (21) sites enrolled subjects. Last patient enrolled on December 22, 2011. Last procedure on December 29, 2011.
Participants by arm
| Arm | Count |
|---|---|
| THERMOCOOL® SMARTTOUCH™ Catheter THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter | 172 |
| Total | 172 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Not Eligible | 11 |
| Overall Study | Withdrawn | 1 |
Baseline characteristics
| Characteristic | THERMOCOOL® SMARTTOUCH™ Catheter |
|---|---|
| Age, Continuous | 58.8 Years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 168 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 165 Participants |
| Region of Enrollment United States | 172 participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 124 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 70 / 161 |
| serious Total, serious adverse events | 38 / 161 |
Outcome results
Primary
Incidence of Early Onset (Within 7 Days of the AF Ablation Procedure) Primary Adverse Events.
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 (initial and prolonged), and Heart block.
Time frame: 7 days of the AF ablation procedure
Population: Safety cohort includes all enrolled subjects who had the study catheter inserted.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| THERMOCOOL® SMARTTOUCH™ Catheter | Incidence of Early Onset (Within 7 Days of the AF Ablation Procedure) Primary Adverse Events. | 9.9 Percentage of patients with primary AE |
Primary
The Rate of Subjects Who Were Free From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 12-month Follow-up
The primary effectiveness endpoint for this study will be freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up (includes a three month blanking period).
Time frame: 12-months
Population: Primary Effectiveness Cohort includes those enrolled who met the inclusion/exclusion criteria and had undergone insertion of the study catheter and Atrial Fibrillation (AF) ablation procedure, excluding those with radiofrequency energy not delivered, with calibration roll-in, and with only non-study arrhythmia.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| THERMOCOOL® SMARTTOUCH™ Catheter | The Rate of Subjects Who Were Free From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 12-month Follow-up | 70.2 percentage of participants |
Comparison: The null hypothesis was that the rate of freedom from documented symptomatic AF/AFL/AT at 12 months would be less than or equal to the pre-determined performance criterion of 50%. The alternative hypothesis was that the rate of freedom from documented symptomatic AF/AFL/AT at 12 months would be greater than the pre-determined performance criterion of 50%.p-value: <0.000195% CI: [60.9, 78.4]Fisher Exact
95% CI: [66, 82]
Secondary
Rate of Acute Success
Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV).
Time frame: End of procedure
Population: The analysis population for this endpoint includes two groups; a): Calibration Roll-in subjects who were prospectively identified prior to the study procedure and b) the Effectiveness Cohort. Both groups underwent an AF ablation procedure with the study catheter.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| THERMOCOOL® SMARTTOUCH™ Catheter | Rate of Acute Success | 100 percentage of participants |
| Calibration Roll-in | Rate of Acute Success | 94.7 percentage of participants |