Atrial Fibrillation, Paroxysmal Arrhythmia
Conditions
Keywords
Symptomatic paroxysmal, Atrial fibrillation, Observational, Acute procedural outcomes, Ablation, Drug refractory, Arrhythmia Recurrent, Symptomatic
Brief summary
This is a prospective, interventional, observational, unblinded, single-arm, multicenter registry of younger and older subjects with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation.
Detailed description
This study is to measure the real-world acute procedural outcomes (procedural efficiency, acute safety, and effectiveness at one year) associated with use of the NAVISTAR® THERMOCOOL® SF Catheter in a clinical setting in subjects with drug refractory, recurrent symptomatic paroxysmal atrial fibrillation.
Interventions
DEVICECatheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter)
Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.
Sponsors
Biosense Webster, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation * Age 18 years or older * Patients must be able and willing to provide written informed consent to participate in the study
Exclusion criteria
* Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause * Previous ablation for atrial fibrillation * Episodes of atrial fibrillation that last longer than 30 days and are terminated via cardioversion * Uncontrolled heart failure, or NYHA Class III or IV heart failure * Documented intra-atrial thrombus or other abnormality on pre-ablation echocardiogram * Contraindication to anticoagulation * Stroke, cardiac surgery, unstable angina, myocardial infarction or percutaneous coronary intervention within the past 3 months * Awaiting cardiac transplantation * Heart disease in which corrective surgery is anticipated within 6 months * Enrollment in investigational drug, biologic or device study * Subjects unwilling to comply with protocol or follow-up requirements * Patients who are pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Fluoroscopy Time | Day 0 (procedure) | The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total time. |
| Total Procedure Time | Day 0 (procedure) | — |
| Acute Procedural Success | Day 0 (procedure) | Confirmation of entrance and/or exit block across all targeted pulmonary veins. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Repeat Ablations | 1 year | — |
| Post-procedure AF Symptoms | 12 Month Visit | Symptoms attributed to paroxysmal atrial fibrillation reported at 12 month visit |
| Number of Subjects With Lost Work Days, Related to AF, at 12 Month Visit | 12 Month Visit | — |
| Mean Number of Radiofrequency (RF) Applications | Day 0 (procedure) | RF applications is defined as the number of times RF energy is delivered during the procedure. |
| Number of Patients With Outpatient Emergency Visits Related to Atrial Fibrillation | 12 Month Visit | — |
| Change in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score | Screening to 12 Month Visit | Change is calculated as 12 month overall AFEQT score minus score at screening. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding extremely limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding not at all limited, difficult or bothersome to all questions answered). Therefore a positive change in score corresponds to improvement in AF symptoms. |
| Number of Patients With Inpatient Hospital Visit(s) Related to Atrial Fibrillation | 12 Month Visit | — |
| Total Radiofrequency (RF) Time | Day 0 (procedure) | Total RF time is defined as the total time that RF energy is delivered during the procedure. |
| Fluid Volume Delivered Via Ablation Catheter | Day 0 (procedure) | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Catheter Ablation These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly. | 511 |
| Total | 511 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Ablation cancelled for slow-heal wound | 1 |
| Overall Study | Death | 6 |
| Overall Study | Decision to use non-study catheter | 1 |
| Overall Study | Lost to Follow-up | 23 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Catheter Ablation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 246 Participants |
| Age, Categorical Between 18 and 65 years | 265 Participants |
| Age, Continuous | 62.0 years STANDARD_DEVIATION 11.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 494 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 477 Participants |
| Region of Enrollment United States | 511 participants |
| Sex: Female, Male Female | 194 Participants |
| Sex: Female, Male Male | 317 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 79 / 508 |
| serious Total, serious adverse events | 63 / 508 |
Outcome results
Primary
Acute Procedural Success
Confirmation of entrance and/or exit block across all targeted pulmonary veins.
Time frame: Day 0 (procedure)
Population: Safety population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Catheter Ablation | Acute Procedural Success | 488 participants |
Primary
Total Fluoroscopy Time
The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total time.
Time frame: Day 0 (procedure)
Population: Subset of Safety Population with non-missing endpoint data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Catheter Ablation | Total Fluoroscopy Time | 26.4 minutes | Standard Deviation 21.4 |
Primary
Total Procedure Time
Time frame: Day 0 (procedure)
Population: Subset of Safety Population with non-missing endpoint data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Catheter Ablation | Total Procedure Time | 169.8 minutes | Standard Deviation 82.9 |
Secondary
Change in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score
Change is calculated as 12 month overall AFEQT score minus score at screening. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding extremely limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding not at all limited, difficult or bothersome to all questions answered). Therefore a positive change in score corresponds to improvement in AF symptoms.
Time frame: Screening to 12 Month Visit
Population: Subset of Safety Population with non-missing AFEQT data at 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Catheter Ablation | Change in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score | 36.0 units on a scale | Standard Deviation 23.7 |
Secondary
Fluid Volume Delivered Via Ablation Catheter
Time frame: Day 0 (procedure)
Population: Subset of Safety Population with non-missing endpoint data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Catheter Ablation | Fluid Volume Delivered Via Ablation Catheter | 974.2 mL | Standard Deviation 481.8 |
Secondary
Mean Number of Radiofrequency (RF) Applications
RF applications is defined as the number of times RF energy is delivered during the procedure.
Time frame: Day 0 (procedure)
Population: Subset of Safety Population with non-missing endpoint data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Catheter Ablation | Mean Number of Radiofrequency (RF) Applications | 45.0 number of applications | Standard Deviation 35.1 |
Secondary
Number of Patients With Inpatient Hospital Visit(s) Related to Atrial Fibrillation
Time frame: 12 Month Visit
Population: Population with Utilization Data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Catheter Ablation | Number of Patients With Inpatient Hospital Visit(s) Related to Atrial Fibrillation | 73 participants |
Secondary
Number of Patients With Outpatient Emergency Visits Related to Atrial Fibrillation
Time frame: 12 Month Visit
Population: Population with Utilization Data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Catheter Ablation | Number of Patients With Outpatient Emergency Visits Related to Atrial Fibrillation | 56 participants |
Secondary
Number of Patients With Repeat Ablations
Time frame: 1 year
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Catheter Ablation | Number of Patients With Repeat Ablations | 74 participants |
Secondary
Number of Subjects With Lost Work Days, Related to AF, at 12 Month Visit
Time frame: 12 Month Visit
Population: Subset of Safety Population with non-missing endpoint data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Catheter Ablation | Number of Subjects With Lost Work Days, Related to AF, at 12 Month Visit | 20 participants |
Secondary
Post-procedure AF Symptoms
Symptoms attributed to paroxysmal atrial fibrillation reported at 12 month visit
Time frame: 12 Month Visit
Population: Subset of Safety Population with non-missing endpoint data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Catheter Ablation | Post-procedure AF Symptoms | 155 participants |
Secondary
Total Radiofrequency (RF) Time
Total RF time is defined as the total time that RF energy is delivered during the procedure.
Time frame: Day 0 (procedure)
Population: Subset of Safety Population with non-missing endpoint data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Catheter Ablation | Total Radiofrequency (RF) Time | 57.9 minutes | Standard Deviation 37 |