Cardiac Arrhythmia, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Conditions
Brief summary
The aim is to use the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ to characterize the atrial substrate and develop a model for predicting recurrence rates after a single procedure using a PVI only approach and a contact catheter.
Detailed description
This clinical investigation is intended to characterize the left atrial substrate using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ in an HD Wave configuration and correlate different factors with 12-month success after a single ablation procedure using a pulmonary vein isolation (PVI) approach without further substrate modification. This is a post-market, single-arm, multi-center, prospective interventional study of the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™. This study is aimed at determining correlations between pre-ablation mapping characteristics and outcomes after catheter ablation of atrial fibrillation. Approximately 300 subjects at up to 20 sites worldwide will be enrolled. Subjects will be followed until they complete their 12-month visit. Clinical Investigation visits will occur at Baseline (confirmation of eligibility), Index Procedure, 3 months, 6 months, and 12 months. Endpoints will be analyzed when all subjects have completed their 12-month follow up visits.
Interventions
PROCEDUREA specific electrophysiology mapping protocol is applicable with the GRID catheter.
The procedure will be done according to a standard ablation approach. During the electrophysiology study, additional mapping data will be collected to support the study endpoints using the GRID catheter.
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
All subjects enrolled will undergo the same mapping and ablation protocol.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Documented atrial fibrillation with planned endocardial ablation procedure 2. Age 18 years or older 3. Able and willing to provide written informed consent prior to any clinical investigation related procedure 4. Able and willing to complete all required study procedures through 12 months
Exclusion criteria
1. Long-standing persistent atrial fibrillation defined as continuous AF greater than 12 months in duration 2. Previous ablation or surgery in the left atria 3. Implanted left atrial appendage occluder 4. Implanted mitral or tricuspid valve replacement 5. Implanted cardiac defibrillator (ICD) 6. Participation in another clinical investigation that may confound the results of this study 7. Pregnant or nursing 8. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results. 9. Life expectancy less than 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With One-year Success | the end of the 3-month blanking period to 12 months following a single ablation procedure | Defined as freedom from atrial fibrillation, atrial flutter and atrial tachycardia after removal from the antiarrhythmic drug therapy as assesses from the end of the 3-month blanking period to 12 months following a single ablation procedure. Kaplan-Meier survival analysis will be conducted to analyze time-to-event variables. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Single Procedure Clinical Success | the end of the 3-month blanking period to 12 months following the initial ablation procedure | Single procedure clinical success was defined as freedom from symptomatic atrial fibrillation, atrial flutter and atrial tachycardia without a new or increased dose of class I or III antiarrhythmic drug. Kaplan-Meier survival analysis was conducted to analyze time-to-event variables. |
| Percentage of Subjects With Freedom From AF/AFL/AT | the end of the 3-month blanking period to 12 months following the initial ablation procedure | Freedom from atrial fibrillation, atrial flutter and atrial tachycardia recurrence. Kaplan-Meier survival analysis was conducted to analyze time-to-event variables. |
| Number of Subjects With Acute Procedural Success | During procedure, an average of 160 minutes | Defined as electrical isolation of all pulmonary veins. The data will be summarized with subject counts and percentages/rates. |
| Percentage of Subjects With Freedom From Symptomatic AF/AFL/AT After Removal From Antiarrhythmic Drug Therapy | the end of the 3-month blanking period to 12 months after initial ablation procedure | Percentage of participants with freedom from symptomatic atrial fibrillation/atrial flutter/atrial tachycardia rafter removal from AADs. Kaplan-Meier survival analysis was conducted to analyze time-to-event variables. |
| Left Atrium (LA) Information: LA Volume (LAV) | Baseline | LA volume will be summarized with the mean with standard deviation. |
| Left Atrium (LA) Information: LA Diameter (LAD) | Baseline | LA diameter will be summarized with the mean with standard deviation. |
| Reportable Adverse Events | 12 months | Number of adverse events, including any device-, procedure-, or death-related events (serious or non-serious). |
| Number of Subjects With Arrhythmia Recurrence | 12 months | Rates of recurrence not due to PVI gap for subjects with repeat electrophysiology studies. The data will be summarized with subject counts and percentages/rates. |
Countries
Austria, Czechia, France, Germany, Italy, Netherlands, Portugal, Spain, United Kingdom
Participant flow
Pre-assignment details
A patient was considered enrolled in the clinical investigation from the moment all of the following enrollment criteria were met: the patient provided written informed consent, patient was confirmed to meet all inclusion criteria and none of the exclusion criteria and the mapping catheter was inserted into the subject's vasculature. If the procedure was cancelled or aborted after consent but prior to the mapping catheter insertion, the subject was withdrawn prior to enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter All patients will undergo a protocol required mapping protocol using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™(GRID) catheter.
A specific electrophysiology mapping protocol is applicable with the GRID catheter. The procedure will be done according to a standard ablation approach. During the electrophysiology study, additional mapping data will be collected to support the study endpoints using the GRID catheter. | 300 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 3-Month to 6-Month Visit | Missed Visit | 1 |
| 6-Month to 12-Month Visit | Death | 1 |
| 6-Month to 12-Month Visit | Missed Visit | 7 |
| Enrollment | HD Grid catheter not introduced into patient | 1 |
| Enrollment | Procedure aborted/cancelled | 2 |
| Enrollment to 3-Month | Death | 1 |
| Enrollment to 3-Month | Missed Visit | 4 |
| Enrollment to 3-Month | Operator not able to achieve PVI | 4 |
Baseline characteristics
| Characteristic | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter | — |
|---|---|---|
| Age, Continuous | 62.0 years STANDARD_DEVIATION 9.5 | — |
| Body Mass Index (BMI) | 28.3 kg/m^2 STANDARD_DEVIATION 4.6 | — |
| Class I/III Anti-arrhythmic drug (AAD) (currently taking/previously taken) | 186 Participants | — |
| Coronary Artery Disease | 33 Participants | — |
| Diabetes | 34 Participants | — |
| Early Persistent Atrial Fibrillation (7 days - 3 months) | 86 Participants | — |
| Evidence of hypertrophic cardiomyopathy | 6 Participants | — |
| Evidence of left ventricular hypertrophy | 47 Participants | — |
| Height | 68.5 inches STANDARD_DEVIATION 3.8 | — |
| History of heart failure | 82 Participants | — |
| History of Hypertension | 179 Participants | — |
| Left Ventricular Ejection Fraction (LVEF) | 57.4 % STANDARD_DEVIATION 8.5 | — |
| New York Heart Association (NYHA) I | 13 Participants | — |
| New York Heart Association (NYHA) II | 48 Participants | — |
| New York Heart Association (NYHA) III | 16 Participants | — |
| New York Heart Association (NYHA) IV | 0 Participants | — |
| New York Heart Association (NYHA) Not evaluated | 5 Participants | — |
| Non-Early Persistent Atrial Fibrillation (3-12 months) | 101 Participants | — |
| Paroxysmal Atrial Fibrillation (less than 7 days) | 113 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Austria | 9 participants | — |
| Region of Enrollment Czechia | 68 participants | — |
| Region of Enrollment France | 74 participants | — |
| Region of Enrollment Germany | 59 participants | — |
| Region of Enrollment Israel | 2 participants | — |
| Region of Enrollment Italy | 43 participants | — |
| Region of Enrollment Netherlands | 13 participants | — |
| Region of Enrollment Poland | 5 participants | — |
| Region of Enrollment Portugal | 5 participants | — |
| Region of Enrollment Spain | 12 participants | — |
| Region of Enrollment United Kingdom | 10 participants | — |
| Sex: Female, Male Female | 89 Participants | — |
| Sex: Female, Male Male | 211 Participants | — |
| Stroke/Transient Ischemic Attack (TIA)/Thromboembolism | 23 Participants | — |
| Subject has a pacemaker | 5 Participants | — |
| Transthoracic Echocardiogram (TTE) performed | 296 Participants | — |
| Typical Atrial Flutter | 47 Participants | — |
| Valvular Heart Disease | 69 Participants | — |
| Weight | 189.3 lbs STANDARD_DEVIATION 37.7 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 300 |
| other Total, other adverse events | 7 / 300 |
| serious Total, serious adverse events | 8 / 300 |
Outcome results
Primary
Percentage of Subjects With One-year Success
Defined as freedom from atrial fibrillation, atrial flutter and atrial tachycardia after removal from the antiarrhythmic drug therapy as assesses from the end of the 3-month blanking period to 12 months following a single ablation procedure. Kaplan-Meier survival analysis will be conducted to analyze time-to-event variables.
Time frame: the end of the 3-month blanking period to 12 months following a single ablation procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter | Percentage of Subjects With One-year Success | 57.2 percentage of participants |
95% CI: [51.2, 62.8]
Other Pre-specified
Left Atrium (LA) Information: LA Diameter (LAD)
LA diameter will be summarized with the mean with standard deviation.
Time frame: Baseline
Population: Includes subjects in which LAD was measured
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter | Left Atrium (LA) Information: LA Diameter (LAD) | 43.1 mm | Standard Deviation 12.2 |
Other Pre-specified
Left Atrium (LA) Information: LA Volume (LAV)
LA volume will be summarized with the mean with standard deviation.
Time frame: Baseline
Population: Number of subjects in which LAV was measured.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter | Left Atrium (LA) Information: LA Volume (LAV) | 68.5 mL | Standard Deviation 31.9 |
Other Pre-specified
Number of Subjects With Acute Procedural Success
Defined as electrical isolation of all pulmonary veins. The data will be summarized with subject counts and percentages/rates.
Time frame: During procedure, an average of 160 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter | Number of Subjects With Acute Procedural Success | 296 Participants |
Other Pre-specified
Number of Subjects With Arrhythmia Recurrence
Rates of recurrence not due to PVI gap for subjects with repeat electrophysiology studies. The data will be summarized with subject counts and percentages/rates.
Time frame: 12 months
Population: Subjects with repeat electrophysiology studies in which treatment other than ablation of isthmus dependent atrial flutter was performed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter | Number of Subjects With Arrhythmia Recurrence | 3 Participants |
Other Pre-specified
Percentage of Subjects With Freedom From AF/AFL/AT
Freedom from atrial fibrillation, atrial flutter and atrial tachycardia recurrence. Kaplan-Meier survival analysis was conducted to analyze time-to-event variables.
Time frame: the end of the 3-month blanking period to 12 months following the initial ablation procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter | Percentage of Subjects With Freedom From AF/AFL/AT | 75.5 percentage of participants |
95% CI: [69.9, 80.1]
Other Pre-specified
Percentage of Subjects With Freedom From Symptomatic AF/AFL/AT After Removal From Antiarrhythmic Drug Therapy
Percentage of participants with freedom from symptomatic atrial fibrillation/atrial flutter/atrial tachycardia rafter removal from AADs. Kaplan-Meier survival analysis was conducted to analyze time-to-event variables.
Time frame: the end of the 3-month blanking period to 12 months after initial ablation procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter | Percentage of Subjects With Freedom From Symptomatic AF/AFL/AT After Removal From Antiarrhythmic Drug Therapy | 61.7 percentage of participants |
95% CI: [55.8, 67.1]
Other Pre-specified
Percentage of Subjects With Single Procedure Clinical Success
Single procedure clinical success was defined as freedom from symptomatic atrial fibrillation, atrial flutter and atrial tachycardia without a new or increased dose of class I or III antiarrhythmic drug. Kaplan-Meier survival analysis was conducted to analyze time-to-event variables.
Time frame: the end of the 3-month blanking period to 12 months following the initial ablation procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter | Percentage of Subjects With Single Procedure Clinical Success | 79.4 percentage of participants |
95% CI: [74.2, 83.6]
Other Pre-specified
Reportable Adverse Events
Number of adverse events, including any device-, procedure-, or death-related events (serious or non-serious).
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter | Reportable Adverse Events | 15 events |