Paroxysmal Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, StablePoint, Paroxysmal Atrial Fibrillation
Brief summary
The NEwTON AF study is a multi-center, global, prospective, single arm study to establish the safety and effectiveness of the IntellaNav StablePoint Catheter and Force-Sensing System in subjects with symptomatic, drug refractory, recurrent paroxysmal atrial fibrillation.
Interventions
DEVICETreatment with IntellaNav StablePoint Ablation Catheter
Patients will be treated with an ablation catheter
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. History of recurrent symptomatic Paroxysmal Atrial Fibrillation (PAF), defined as atrial fibrillation (AF) that terminates spontaneously or with intervention (either procedure or drug therapy) within seven days of onset. Minimum documentation includes the following: a physician's note indicating recurrent self-terminating atrial fibrillation (AF) which includes at least two symptomatic AF episodes in the patient's history within the last 6 months prior to enrollment, and any electrocardiographically documented AF episode within 12 months prior to enrollment. 2. Subjects who are eligible for an ablation procedure for PAF according to 2017 HRS expert consensus statement on catheter ablation of atrial fibrillation; 3. Subjects refractory or intolerant to at least one class I or class III antiarrhythmic medication or contraindicated to any class I or class III medications; 4. Subjects who are willing and capable of providing informed consent; 5. Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center; 6. Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.
Exclusion criteria
1. Subjects with New York Heart Association (NYHA) Class III or IV heart failure \< 180 days prior to enrollment 2. Left atrial diameter \> 5.0 cm or left atrial volume \>50 ml/m² indexed based on the most recent echocardiography+ 3. Left ventricular ejection fraction \< 35% based on the most recent echocardiogram + 4. Continuous AF lasting longer than seven (7) days 5. Subjects who have undergone any previous left atrial cardiac ablation (RF, Cryo, surgical) 6. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause 7. Subjects who have undergone any cardiac ablation or any surgery within 30 days prior to enrollment 8. Currently implanted with a pacemaker, ICD, CRT device, or an implanted arrhythmia loop recorder 9. Active systemic infection 10. Unstable angina or ongoing myocardial ischemia 11. Myocardial Infarction (MI) within 90 days prior to enrollment 12. Evidence of myxoma, left atrial thrombus or intracardiac mural thrombus++ 13. Previous cardiac surgery (i.e. ventriculotomy, atriotomy, CABG, PTCA, PCI, coronary stenting procedures) ≤ 90 days prior to enrollment. 14. Severe valvular disease, including mechanical prosthetic mitral or tricuspid heart valves (patients with successful mitral valve repair allowed - annular ring constitutes repair); 15. Any prior history of documented cerebral infarct, TIA or systemic embolism \[excluding a post-operative deep vein thrombosis (DVT)\] \<180 days prior to enrollment 16. Moderate or severe mitral stenosis (severity assessed on the most recent TTE ≤180 days prior to enrollment. Defined as pulmonary artery systolic pressure \>30 mmHg) 17. Presence of left atrial appendage closure device 18. Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder 19. Subjects who, in the judgment of the investigator, have a life expectancy of less than two (2) years 20. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon investigator's discretion) 21. Amiodarone use within 60 days prior to enrollment 22. Any carotid stenting or endarterectomy 23. Stage 3B renal disease or higher (estimated glomerular filtration rate, eGFR \<45 mL/min) 24. Known coagulopathy disorder (e.g. von Willebrand's disease, hemophilia) 25. Any known contraindication to an AF ablation 26. Any known contraindication for anticoagulation (e.g. patients unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation) 27. Vena cava embolic protection filter devices and/or known femoral thrombus that prevents catheter insertion from the femoral approach 28. Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication 29. Rheumatic Heart Disease 30. Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter 31. Subjects unable or unwilling to complete follow-up visits and examinations for the duration of the clinical study 32. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the sponsor to determine eligibility. * LVEF and LA diameters obtained ≤180 days prior to enrollment will be acceptable, unless a cardiac event has occurred (e.g. MI) between the date of the exam and the enrollment date. In this case, a new echocardiogram (trans-thoracic or trans-esophageal, or intracardiac echo) must be performed to confirm eligibility prior to performing ablation. If no recent (≤180 days prior to enrollment) echocardiogram is available at the time of the enrollment, a new echocardiogram must be performed either prior to enrolling the patient into the study or post-consent to confirm patient's eligibility prior to performing the ablation. For TTE, LA anteroposterior diameter measured by M-mode from the parasternal long-axis view will be used. If both LA diameter and volume are available and at least one of them meets the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Primary Safety Events at 1-Month Post-Procedure | Up to 30 Days | The primary safety endpoint at 30 days is defined as the safety event-free rate at 1-Month (30 days) post-procedure. |
| Rate of Primary Safety Events at 12-Months Post-Procedure | 12 Months | The primary safety endpoint at 12 months is defined as the safety event-free rate at 12 months post-procedure. |
| Percentage of Participants With Freedom From Treatment Failure at 12-Months Post-Procedure | 12 Months | The twelve-month effectiveness endpoint is defined as the event-free rate at twelve-month post-procedure. |
| Number of Participants That Achieved Electrical Isolation of All Pulmonary Veins | 30 Days | The primary effectiveness endpoint of acute procedural success is defined as the achievement of electrical isolation of all PVs using the IntellaNav StablePoint catheter only. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With New or Increased Dose of AAD | 12 Months | Secondary Effectiveness Endpoint 1 - New or Increased Dose of AAD |
| Rate of SAEs Through 12-Months Post-Procedure | 12 Months | Secondary Safety Endpoint - SAEs |
| Percentage of Participants With Freedom From Primary Effectiveness Failure Without a Repeat Procedure | 12 Months | Secondary Effectiveness Endpoint 2 - Single Procedure Success defined as freedom from primary effectiveness failure without a repeat procedure |
| Rate of AEs Through 12-Months Post-Procedure | 12 Months | Secondary Safety Endpoint - AE Rates |
| Percentage of Participants With Freedom From Documented Symptomatic Atrial Fibrillation, Atrial Flutter and Atrial Tachycardia Recurrence | 12 Months | Secondary Effectiveness Endpoint 3 - Symptomatic Recurrence: freedom from documented symptomatic AF/AT/AFL recurrence |
Countries
Austria, Belgium, Canada, France, Germany, Hong Kong, Italy, Japan, Monaco, Netherlands, Taiwan, United Kingdom, United States
Participant flow
Pre-assignment details
A total of 299 subjects were enrolled in the NEwTON AF study and subsequently classified as Treatment subjects undergoing an ablation procedure with the Investigational IntellaNav™ StablePoint Catheter System. Of the Treatment subjects, eight (8) were lost to follow-up (2 subjects) or withdrew from the study prior to study completion (6 subjects).
Participants by arm
| Arm | Count |
|---|---|
| Treatment With Ablation Catheter Patients who undergo treatment with the ablation catheter for the treatment of paroxysmal atrial fibrillation
Treatment with IntellaNav StablePoint Ablation Catheter: Patients will be treated with an ablation catheter | 299 |
| Total | 299 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Treatment With Ablation Catheter |
|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 12 |
| Atrial Arrhythmia History Atrial Fibrillation | 299 Participants |
| Atrial Arrhythmia History Atrial Flutter | 95 Participants |
| Atrial Arrhythmia History Atrial Tachycardia | 95 Participants |
| Atrial Arrhythmia History Other Atrial Arrhythmia | 18 Participants |
| Atrial Arrhythmia History Typical Atrial Flutter | 73 Participants |
| Baseline 12-lead ECG Rhythm [N (%)] Atrial Fibrillation (AF) | 29 Participants |
| Baseline 12-lead ECG Rhythm [N (%)] Atrial Flutter (Not defined) | 3 Participants |
| Baseline 12-lead ECG Rhythm [N (%)] Atrial Flutter (Typical Right Cavo Tricuspid Isthmus dependent) | 1 Participants |
| Baseline 12-lead ECG Rhythm [N (%)] Ectopic Atrial Bradycardia | 1 Participants |
| Baseline 12-lead ECG Rhythm [N (%)] Not Assessed/Reported | 6 Participants |
| Baseline 12-lead ECG Rhythm [N (%)] Sinus Bradycardia | 81 Participants |
| Baseline 12-lead ECG Rhythm [N (%)] Sinus Brady with PAC's | 1 Participants |
| Baseline 12-lead ECG Rhythm [N (%)] Sinus Rhythm | 176 Participants |
| Baseline 12-lead ECG Rhythm [N (%)] Sinus Rhythm with 1st degree block | 1 Participants |
| BMI | 29 percentage STANDARD_DEVIATION 6 |
| Brady Arrhythmia History AV Block 1 | 19 Participants |
| Brady Arrhythmia History AV Block 2 | 2 Participants |
| Brady Arrhythmia History AV Block 3 | 0 Participants |
| Brady Arrhythmia History None | 183 Participants |
| Brady Arrhythmia History Other Brady Arrhythmia | 1 Participants |
| Brady Arrhythmia History Sick Sinus Syndrome Chronotropic Incompetence | 4 Participants |
| Brady Arrhythmia History Sinus Arrest | 3 Participants |
| Brady Arrhythmia History Sinus Bradycardia | 107 Participants |
| Brady Arrhythmia History Sinus Node Dysfunction | 6 Participants |
| Cardiac Ablation History Any Cardiac Ablation | 18 Participants |
| Cardiac Ablation History Any Left Atrial Ablation | 0 Participants |
| Cardiac Ablation History None | 281 Participants |
| Cardiac Disease History Angina Pectoris | 12 Participants |
| Cardiac Disease History Cerebrovascular Disease | 4 Participants |
| Cardiac Disease History Congenital Heart Disease | 1 Participants |
| Cardiac Disease History Congestive Heart Failure | 16 Participants |
| Cardiac Disease History DVT | 6 Participants |
| Cardiac Disease History Dyslipidemia | 93 Participants |
| Cardiac Disease History Hypertension | 131 Participants |
| Cardiac Disease History Ischemic Cardiomyopathy | 1 Participants |
| Cardiac Disease History Myocardial Infarction | 3 Participants |
| Cardiac Disease History None | 127 Participants |
| Cardiac Disease History Non-ischemic Cardiomyopathy | 8 Participants |
| Cardiac Disease History Other Cardiovascular Disease | 17 Participants |
| Cardiac Disease History Peripheral Vascular Disease | 8 Participants |
| Cardiac Disease History Pulmonary Embolism | 4 Participants |
| Cardiac Disease History Pulmonary Hypertension | 8 Participants |
| Cardiac Procedure History ASD Intervention | 0 Participants |
| Cardiac Procedure History CABG | 5 Participants |
| Cardiac Procedure History Cardiac Valve | 0 Participants |
| Cardiac Procedure History Heart Transplant | 0 Participants |
| Cardiac Procedure History LAAC | 1 Participants |
| Cardiac Procedure History None | 269 Participants |
| Cardiac Procedure History Other Cardiovascular Procedure | 10 Participants |
| Cardiac Procedure History Pacemaker/ICD/CRT | 0 Participants |
| Cardiac Procedure History PFO Intervention | 0 Participants |
| Cardiac Procedure History PTCA | 9 Participants |
| Cardiac Procedure History Stent | 15 Participants |
| Diastolic BP | 78 mmHg STANDARD_DEVIATION 11 |
| Heart Auscultation Normal Heart Sounds | 295 Participants |
| Heart Auscultation Other | 4 Participants |
| Height | 172 cm STANDARD_DEVIATION 11 |
| Lung Auscultation Crackles | 1 Participants |
| Lung Auscultation Normal | 296 Participants |
| Lung Auscultation Not Assessed/Reported | 1 Participants |
| Lung Auscultation Rhonchi | 1 Participants |
| Neurological Medical History Carotid Artery Disease | 2 Participants |
| Neurological Medical History CVA | 3 Participants |
| Neurological Medical History None | 287 Participants |
| Neurological Medical History TIA | 7 Participants |
| Non-Cardiac Comorbidities COPD | 12 participants |
| Non-Cardiac Comorbidities Diabetes (Type 1) | 2 participants |
| Non-Cardiac Comorbidities Diabetes (Type 2) | 33 participants |
| Non-Cardiac Comorbidities Gastrointestinal Disorder | 42 participants |
| Non-Cardiac Comorbidities Hepatic Disease | 5 participants |
| Non-Cardiac Comorbidities None | 147 participants |
| Non-Cardiac Comorbidities Other Non-Cardiac Co-Morbidities | 85 participants |
| Non-Cardiac Comorbidities Renal Disease | 7 participants |
| Non-Cardiac Comorbidities Sleep Disordered Breathing | 49 participants |
| Pulse | 69 bpm STANDARD_DEVIATION 15 |
| Race/Ethnicity, Customized Asian | 48 Participants |
| Race/Ethnicity, Customized Black | 3 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 5 Participants |
| Race/Ethnicity, Customized Native American | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Race Undisclosed | 5 Participants |
| Race/Ethnicity, Customized White | 244 Participants |
| Region of Enrollment Austria | 14 participants |
| Region of Enrollment Belgium | 7 participants |
| Region of Enrollment Canada | 14 participants |
| Region of Enrollment Germany | 4 participants |
| Region of Enrollment Hong Kong | 6 participants |
| Region of Enrollment Italy | 31 participants |
| Region of Enrollment Japan | 6 participants |
| Region of Enrollment Monaco | 1 participants |
| Region of Enrollment Netherlands | 2 participants |
| Region of Enrollment Taiwan | 33 participants |
| Region of Enrollment United Kingdom | 13 participants |
| Region of Enrollment United States | 168 participants |
| Respiratory Rate | 16 breaths per minute STANDARD_DEVIATION 2 |
| Respiratory Rhythm Irregular | 2 Participants |
| Respiratory Rhythm Regular | 296 Participants |
| Sex: Female, Male Female | 118 Participants |
| Sex: Female, Male Male | 181 Participants |
| Systolic BP | 134 mmHg STANDARD_DEVIATION 20 |
| Ventricular Arrhythmia History None | 264 Participants |
| Ventricular Arrhythmia History Other Ventricular Arrhythmia | 25 Participants |
| Ventricular Arrhythmia History Ventricular Fibrillation | 0 Participants |
| Ventricular Arrhythmia History Ventricular Tachycardia | 15 Participants |
| Weight | 86 kg STANDARD_DEVIATION 21 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 299 |
| other Total, other adverse events | 64 / 299 |
| serious Total, serious adverse events | 47 / 299 |
Outcome results
Primary
Number of Participants That Achieved Electrical Isolation of All Pulmonary Veins
The primary effectiveness endpoint of acute procedural success is defined as the achievement of electrical isolation of all PVs using the IntellaNav StablePoint catheter only.
Time frame: 30 Days
Population: Acute procedural success was observed in 294 (98.3%) of the 299 Treatment subjects that underwent an ablation procedure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment With Ablation Catheter | Number of Participants That Achieved Electrical Isolation of All Pulmonary Veins | 294 Participants |
Primary
Percentage of Participants With Freedom From Treatment Failure at 12-Months Post-Procedure
The twelve-month effectiveness endpoint is defined as the event-free rate at twelve-month post-procedure.
Time frame: 12 Months
Population: The freedom from primary effectiveness failure at 12 months is 60.5%.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment With Ablation Catheter | Percentage of Participants With Freedom From Treatment Failure at 12-Months Post-Procedure | 181 Participants |
Primary
Rate of Primary Safety Events at 12-Months Post-Procedure
The primary safety endpoint at 12 months is defined as the safety event-free rate at 12 months post-procedure.
Time frame: 12 Months
Population: Of the 299 treatment subjects, a total of 13 primary safety events occurred through 12 months in 12 subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment With Ablation Catheter | Rate of Primary Safety Events at 12-Months Post-Procedure | 13 primary safety events |
Primary
Rate of Primary Safety Events at 1-Month Post-Procedure
The primary safety endpoint at 30 days is defined as the safety event-free rate at 1-Month (30 days) post-procedure.
Time frame: Up to 30 Days
Population: Of the 299 treatment subjects, a total of 13 primary safety events occurred through 30 days in 12 subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment With Ablation Catheter | Rate of Primary Safety Events at 1-Month Post-Procedure | 13 primary safety events |
Secondary
Number of Patients With New or Increased Dose of AAD
Secondary Effectiveness Endpoint 1 - New or Increased Dose of AAD
Time frame: 12 Months
Population: Subjects were only counted as effectiveness failures if a new AAD or higher dose of a previously failed AAD continued after the blanking period.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment With Ablation Catheter | Number of Patients With New or Increased Dose of AAD | Subjects with New or Increased Dose of AAD | 103 Participants |
| Treatment With Ablation Catheter | Number of Patients With New or Increased Dose of AAD | Subjects with No New or Increased Dose of AAD | 193 Participants |
Secondary
Percentage of Participants With Freedom From Documented Symptomatic Atrial Fibrillation, Atrial Flutter and Atrial Tachycardia Recurrence
Secondary Effectiveness Endpoint 3 - Symptomatic Recurrence: freedom from documented symptomatic AF/AT/AFL recurrence
Time frame: 12 Months
Population: The freedom from documented arrhythmia recurrence, including atrial fibrillation (AF), atrial flutter (AFL), and atrial tachycardia (AT), was 71%.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment With Ablation Catheter | Percentage of Participants With Freedom From Documented Symptomatic Atrial Fibrillation, Atrial Flutter and Atrial Tachycardia Recurrence | 211 Participants |
Secondary
Percentage of Participants With Freedom From Primary Effectiveness Failure Without a Repeat Procedure
Secondary Effectiveness Endpoint 2 - Single Procedure Success defined as freedom from primary effectiveness failure without a repeat procedure
Time frame: 12 Months
Population: 59% of subjects were free from primary effectiveness failure without a repeat procedure at 12-months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment With Ablation Catheter | Percentage of Participants With Freedom From Primary Effectiveness Failure Without a Repeat Procedure | 175 Participants |
Secondary
Rate of AEs Through 12-Months Post-Procedure
Secondary Safety Endpoint - AE Rates
Time frame: 12 Months
Population: Adverse events (AEs) that occurred during the study were continuously monitored. A total of 156 events were reported in 97 of the 299 Treatment subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment With Ablation Catheter | Rate of AEs Through 12-Months Post-Procedure | 156 Events Reported |
Secondary
Rate of SAEs Through 12-Months Post-Procedure
Secondary Safety Endpoint - SAEs
Time frame: 12 Months
Population: Adverse events (AEs) that occurred during the study were continuously monitored. A total of 156 events were reported in 97 of the 299 Treatment subjects. A total of 72 Serious Adverse Events (SAEs) were reported in 47 Treatment subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment With Ablation Catheter | Rate of SAEs Through 12-Months Post-Procedure | 72 Total number of reported SAEs |