Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation
Conditions
Keywords
Drug refractory, Atrial fibrillation, Antiarrhythmic drug failure, Atrial tachyarrhythmias
Brief summary
This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.
Detailed description
The device is currently under investigation with IDE #G110030. This continued access study will enroll subjects that have participated in the Smart-AF IDE study. Subjects with drug refractory symptomatic paroxysmal atrial fibrillation (PAF) will be considered for this study. Effectiveness and safety endpoints have been defined and will be evaluated post treatment.
Interventions
AF Ablation
Sponsors
Biosense Webster, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study had a single arm: catheter ablation for PAF
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
including, but not limited to: * 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 |
|---|---|---|
| Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias | Day 91-361 | Freedom from documented symptomatic atrial fibrillation/atrial tachycardia/atrial flutter (hereinafter collectively referred to as atrial tachyarrhythmias) based on electrocardiographic data during the effectiveness evaluation period (Day 91-361). Acute procedure failures, antiarrhythmic drug(AAD) changes and repeat ablation occurring during evaluation period were deemed as primary effectiveness failures |
| Incidence of Primary Adverse Events Within Specified Study Period | 12 months post procedure | Primary safety endpoint consists of primary adverse events (AE) within 7 days post procedure Or pulmonary vein stenosis and atrio-esophageal fistula events that occurred within 12 months post-procedure. Primary 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, initial and prolonged hospitalization (excluding those due to pre-existing arrhythmia recurrence), heart block. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peri-procedural Serious Adverse Events | Within 8-30 days post procedure | Peri-procedural serious adverse events (SAEs) are those non-primary SAEs occurred within 8-30 days post procedure |
| Percentage of Subjects Achieved Acute Effectiveness | 5 hours of procedure time | Acute effectivenesss is defined as confirmation of entrance block into all Pulmonary veins |
| Late Onset Serious Adverse Events | From 31 days post procedure to month 12 | Late onset serious adverse events (SAEs) are those non-primary SAEs occurred after 31 days post procedure |
Countries
United States
Participant flow
Recruitment details
This study enrolled 148 subjects at 15 clinical sites in the U.S. over the course of approximately 8 months. The first subject was enrolled on July 26, 2012, and the last subject was enrolled on March 18, 2013. The study's last index ablation procedure was on April 24, 2013.
Participants by arm
| Arm | Count |
|---|---|
| THERMOCOOL® SMARTTOUCH™ Catheter THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation | 148 |
| Total | 148 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Consented but didn't have study catheter | 4 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | No radiofrequency energy applied | 2 |
| Overall Study | Not meeting inclusion/exclusion criteria | 4 |
Baseline characteristics
| Characteristic | THERMOCOOL® SMARTTOUCH™ Catheter |
|---|---|
| Age, Continuous | 61.1 years STANDARD_DEVIATION 10.36 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 146 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 | 1 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 | 0 Participants |
| Race (NIH/OMB) White | 147 Participants |
| Region of Enrollment United States | 148 Participants |
| Sex: Female, Male Female | 43 Participants |
| Sex: Female, Male Male | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 40 / 144 |
| serious Total, serious adverse events | 46 / 144 |
Outcome results
Primary
Incidence of Primary Adverse Events Within Specified Study Period
Primary safety endpoint consists of primary adverse events (AE) within 7 days post procedure Or pulmonary vein stenosis and atrio-esophageal fistula events that occurred within 12 months post-procedure. Primary 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, initial and prolonged hospitalization (excluding those due to pre-existing arrhythmia recurrence), heart block.
Time frame: 12 months post procedure
Population: 144 subjects that had study catheter inserted into their body; INCLUDES study ineligible \& untreated subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| THERMOCOOL® SMARTTOUCH™ Catheter | Incidence of Primary Adverse Events Within Specified Study Period | Primary Safety Cohort | 17.4 percentage of subjects with primary AE |
| THERMOCOOL® SMARTTOUCH™ Catheter | Incidence of Primary Adverse Events Within Specified Study Period | Male | 13.7 percentage of subjects with primary AE |
| THERMOCOOL® SMARTTOUCH™ Catheter | Incidence of Primary Adverse Events Within Specified Study Period | Female | 26.2 percentage of subjects with primary AE |
95% CI: [11.6, 24.6]
Primary
Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias
Freedom from documented symptomatic atrial fibrillation/atrial tachycardia/atrial flutter (hereinafter collectively referred to as atrial tachyarrhythmias) based on electrocardiographic data during the effectiveness evaluation period (Day 91-361). Acute procedure failures, antiarrhythmic drug(AAD) changes and repeat ablation occurring during evaluation period were deemed as primary effectiveness failures
Time frame: Day 91-361
Population: 137 Study-eligible subjects with per-protocol procedure. CENSORED: 1 lost to follow-up subject without recurrence
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| THERMOCOOL® SMARTTOUCH™ Catheter | Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias | Primary Effectiveness Cohort | 60.6 Percentage of participants |
| THERMOCOOL® SMARTTOUCH™ Catheter | Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias | Male | 60.8 Percentage of participants |
| THERMOCOOL® SMARTTOUCH™ Catheter | Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias | Female | 60 Percentage of participants |
95% CI: [51.9, 68.8]
Secondary
Late Onset Serious Adverse Events
Late onset serious adverse events (SAEs) are those non-primary SAEs occurred after 31 days post procedure
Time frame: From 31 days post procedure to month 12
Population: Safety cohort, including Enrolled subjects who underwent insertion of the study catheter.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| THERMOCOOL® SMARTTOUCH™ Catheter | Late Onset Serious Adverse Events | Number of subjects had late onset SAEs | 27 Number of participants |
| THERMOCOOL® SMARTTOUCH™ Catheter | Late Onset Serious Adverse Events | Procedure related | 1 Number of participants |
| THERMOCOOL® SMARTTOUCH™ Catheter | Late Onset Serious Adverse Events | Not-related to procedure or device | 26 Number of participants |
Secondary
Percentage of Subjects Achieved Acute Effectiveness
Acute effectivenesss is defined as confirmation of entrance block into all Pulmonary veins
Time frame: 5 hours of procedure time
Population: Effectiveness cohort, defined as those enrolled subjects who underwent insertion of the study catheter and an AF ablation procedure. Subjects without RF energy delivery will be excluded (i.e. discontinued subjects).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| THERMOCOOL® SMARTTOUCH™ Catheter | Percentage of Subjects Achieved Acute Effectiveness | 97.2 Percentage of participants |
95% CI: [95.6, 98.2]
Secondary
Peri-procedural Serious Adverse Events
Peri-procedural serious adverse events (SAEs) are those non-primary SAEs occurred within 8-30 days post procedure
Time frame: Within 8-30 days post procedure
Population: Safety cohort, including Enrolled subjects who underwent insertion of the study catheter.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| THERMOCOOL® SMARTTOUCH™ Catheter | Peri-procedural Serious Adverse Events | Possibly procedure related | 2 Number of participants |
| THERMOCOOL® SMARTTOUCH™ Catheter | Peri-procedural Serious Adverse Events | Not-related to procedure or device | 1 Number of participants |
| THERMOCOOL® SMARTTOUCH™ Catheter | Peri-procedural Serious Adverse Events | Number of subjects had peri-procedural SAEs | 2 Number of participants |