Trial Outcomes & Findings for Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation (NCT NCT04580914)
NCT ID: NCT04580914
Last Updated: 2025-01-16
Results Overview
The primary safety endpoint at 30 days is defined as the safety event-free rate at 1-Month (30 days) post-procedure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
321 participants
Primary outcome timeframe
Up to 30 Days
Results posted on
2025-01-16
Participant Flow
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).
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
299
|
|
Overall Study
COMPLETED
|
291
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Baseline assessment was completed for 298 of 299 Treatment subjects as baseline was missed for one subject in an oversight.
Baseline characteristics by cohort
| Measure |
Treatment With Ablation Catheter
n=299 Participants
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
|
|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 12 • n=299 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=299 Participants
|
|
Sex: Female, Male
Male
|
181 Participants
n=299 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 Participants
n=299 Participants
|
|
Race/Ethnicity, Customized
Native American
|
0 Participants
n=299 Participants
|
|
Race/Ethnicity, Customized
Asian
|
48 Participants
n=299 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=299 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
0 Participants
n=299 Participants
|
|
Race/Ethnicity, Customized
White
|
244 Participants
n=299 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=299 Participants
|
|
Race/Ethnicity, Customized
Race Undisclosed
|
5 Participants
n=299 Participants
|
|
Region of Enrollment
Hong Kong
|
6 participants
n=299 Participants
|
|
Region of Enrollment
United States
|
168 participants
n=299 Participants
|
|
Region of Enrollment
Japan
|
6 participants
n=299 Participants
|
|
Region of Enrollment
United Kingdom
|
13 participants
n=299 Participants
|
|
Region of Enrollment
Canada
|
14 participants
n=299 Participants
|
|
Region of Enrollment
Austria
|
14 participants
n=299 Participants
|
|
Region of Enrollment
Netherlands
|
2 participants
n=299 Participants
|
|
Region of Enrollment
Belgium
|
7 participants
n=299 Participants
|
|
Region of Enrollment
Monaco
|
1 participants
n=299 Participants
|
|
Region of Enrollment
Taiwan
|
33 participants
n=299 Participants
|
|
Region of Enrollment
Italy
|
31 participants
n=299 Participants
|
|
Region of Enrollment
Germany
|
4 participants
n=299 Participants
|
|
Height
|
172 cm
STANDARD_DEVIATION 11 • n=298 Participants • Baseline assessment was completed for 298 of 299 Treatment subjects as baseline was missed for one subject in an oversight.
|
|
Weight
|
86 kg
STANDARD_DEVIATION 21 • n=298 Participants • Baseline assessment was completed for 298 of 299 Treatment subjects as baseline was missed for one subject in an oversight.
|
|
BMI
|
29 percentage
STANDARD_DEVIATION 6 • n=298 Participants • Baseline assessment was completed for 298 of 299 Treatment subjects as baseline was missed for one subject in an oversight.
|
|
Pulse
|
69 bpm
STANDARD_DEVIATION 15 • n=298 Participants • Baseline assessment was completed for 298 of 299 Treatment subjects as baseline was missed for one subject in an oversight.
|
|
Systolic BP
|
134 mmHg
STANDARD_DEVIATION 20 • n=298 Participants • Baseline assessment was completed for 298 of 299 Treatment subjects as baseline was missed for one subject in an oversight.
|
|
Diastolic BP
|
78 mmHg
STANDARD_DEVIATION 11 • n=298 Participants • Baseline assessment was completed for 298 of 299 Treatment subjects as baseline was missed for one subject in an oversight.
|
|
Heart Auscultation
Normal Heart Sounds
|
295 Participants
n=299 Participants
|
|
Heart Auscultation
Other
|
4 Participants
n=299 Participants
|
|
Baseline 12-lead ECG Rhythm [N (%)]
Sinus Rhythm
|
176 Participants
n=299 Participants
|
|
Baseline 12-lead ECG Rhythm [N (%)]
Sinus Bradycardia
|
81 Participants
n=299 Participants
|
|
Baseline 12-lead ECG Rhythm [N (%)]
Atrial Fibrillation (AF)
|
29 Participants
n=299 Participants
|
|
Baseline 12-lead ECG Rhythm [N (%)]
Atrial Flutter (Not defined)
|
3 Participants
n=299 Participants
|
|
Baseline 12-lead ECG Rhythm [N (%)]
Atrial Flutter (Typical Right Cavo Tricuspid Isthmus dependent)
|
1 Participants
n=299 Participants
|
|
Baseline 12-lead ECG Rhythm [N (%)]
Sinus Brady with PAC's
|
1 Participants
n=299 Participants
|
|
Baseline 12-lead ECG Rhythm [N (%)]
Ectopic Atrial Bradycardia
|
1 Participants
n=299 Participants
|
|
Baseline 12-lead ECG Rhythm [N (%)]
Sinus Rhythm with 1st degree block
|
1 Participants
n=299 Participants
|
|
Baseline 12-lead ECG Rhythm [N (%)]
Not Assessed/Reported
|
6 Participants
n=299 Participants
|
|
Respiratory Rate
|
16 breaths per minute
STANDARD_DEVIATION 2 • n=288 Participants • Baseline measure not calculated for all Treatment subjects.
|
|
Respiratory Rhythm
Regular
|
296 Participants
n=298 Participants • Baseline assessment was completed for 298 of 299 Treatment subjects as baseline was missed for one subject in an oversight.
|
|
Respiratory Rhythm
Irregular
|
2 Participants
n=298 Participants • Baseline assessment was completed for 298 of 299 Treatment subjects as baseline was missed for one subject in an oversight.
|
|
Lung Auscultation
Normal
|
296 Participants
n=299 Participants
|
|
Lung Auscultation
Crackles
|
1 Participants
n=299 Participants
|
|
Lung Auscultation
Rhonchi
|
1 Participants
n=299 Participants
|
|
Lung Auscultation
Not Assessed/Reported
|
1 Participants
n=299 Participants
|
|
Cardiac Disease History
None
|
127 Participants
n=299 Participants
|
|
Cardiac Disease History
Ischemic Cardiomyopathy
|
1 Participants
n=299 Participants
|
|
Cardiac Disease History
Non-ischemic Cardiomyopathy
|
8 Participants
n=299 Participants
|
|
Cardiac Disease History
Myocardial Infarction
|
3 Participants
n=299 Participants
|
|
Cardiac Disease History
Angina Pectoris
|
12 Participants
n=299 Participants
|
|
Cardiac Disease History
Congenital Heart Disease
|
1 Participants
n=299 Participants
|
|
Cardiac Disease History
Congestive Heart Failure
|
16 Participants
n=299 Participants
|
|
Cardiac Disease History
Cerebrovascular Disease
|
4 Participants
n=299 Participants
|
|
Cardiac Disease History
Peripheral Vascular Disease
|
8 Participants
n=299 Participants
|
|
Cardiac Disease History
Hypertension
|
131 Participants
n=299 Participants
|
|
Cardiac Disease History
Pulmonary Hypertension
|
8 Participants
n=299 Participants
|
|
Cardiac Disease History
Dyslipidemia
|
93 Participants
n=299 Participants
|
|
Cardiac Disease History
Pulmonary Embolism
|
4 Participants
n=299 Participants
|
|
Cardiac Disease History
DVT
|
6 Participants
n=299 Participants
|
|
Cardiac Disease History
Other Cardiovascular Disease
|
17 Participants
n=299 Participants
|
|
Neurological Medical History
None
|
287 Participants
n=299 Participants
|
|
Neurological Medical History
Carotid Artery Disease
|
2 Participants
n=299 Participants
|
|
Neurological Medical History
TIA
|
7 Participants
n=299 Participants
|
|
Neurological Medical History
CVA
|
3 Participants
n=299 Participants
|
|
Cardiac Procedure History
None
|
269 Participants
n=299 Participants
|
|
Cardiac Procedure History
PTCA
|
9 Participants
n=299 Participants
|
|
Cardiac Procedure History
Stent
|
15 Participants
n=299 Participants
|
|
Cardiac Procedure History
CABG
|
5 Participants
n=299 Participants
|
|
Cardiac Procedure History
Pacemaker/ICD/CRT
|
0 Participants
n=299 Participants
|
|
Cardiac Procedure History
Cardiac Valve
|
0 Participants
n=299 Participants
|
|
Cardiac Procedure History
LAAC
|
1 Participants
n=299 Participants
|
|
Cardiac Procedure History
PFO Intervention
|
0 Participants
n=299 Participants
|
|
Cardiac Procedure History
ASD Intervention
|
0 Participants
n=299 Participants
|
|
Cardiac Procedure History
Heart Transplant
|
0 Participants
n=299 Participants
|
|
Cardiac Procedure History
Other Cardiovascular Procedure
|
10 Participants
n=299 Participants
|
|
Ventricular Arrhythmia History
None
|
264 Participants
n=299 Participants
|
|
Ventricular Arrhythmia History
Ventricular Tachycardia
|
15 Participants
n=299 Participants
|
|
Ventricular Arrhythmia History
Ventricular Fibrillation
|
0 Participants
n=299 Participants
|
|
Ventricular Arrhythmia History
Other Ventricular Arrhythmia
|
25 Participants
n=299 Participants
|
|
Atrial Arrhythmia History
Atrial Fibrillation
|
299 Participants
n=299 Participants
|
|
Atrial Arrhythmia History
Atrial Tachycardia
|
95 Participants
n=299 Participants
|
|
Atrial Arrhythmia History
Atrial Flutter
|
95 Participants
n=299 Participants
|
|
Atrial Arrhythmia History
Typical Atrial Flutter
|
73 Participants
n=299 Participants
|
|
Atrial Arrhythmia History
Other Atrial Arrhythmia
|
18 Participants
n=299 Participants
|
|
Brady Arrhythmia History
None
|
183 Participants
n=299 Participants
|
|
Brady Arrhythmia History
Sinus Bradycardia
|
107 Participants
n=299 Participants
|
|
Brady Arrhythmia History
Sinus Node Dysfunction
|
6 Participants
n=299 Participants
|
|
Brady Arrhythmia History
Sick Sinus Syndrome Chronotropic Incompetence
|
4 Participants
n=299 Participants
|
|
Brady Arrhythmia History
Sinus Arrest
|
3 Participants
n=299 Participants
|
|
Brady Arrhythmia History
AV Block 1
|
19 Participants
n=299 Participants
|
|
Brady Arrhythmia History
AV Block 2
|
2 Participants
n=299 Participants
|
|
Brady Arrhythmia History
AV Block 3
|
0 Participants
n=299 Participants
|
|
Brady Arrhythmia History
Other Brady Arrhythmia
|
1 Participants
n=299 Participants
|
|
Cardiac Ablation History
None
|
281 Participants
n=299 Participants
|
|
Cardiac Ablation History
Any Left Atrial Ablation
|
0 Participants
n=299 Participants
|
|
Cardiac Ablation History
Any Cardiac Ablation
|
18 Participants
n=299 Participants
|
|
Non-Cardiac Comorbidities
None
|
147 participants
n=299 Participants
|
|
Non-Cardiac Comorbidities
COPD
|
12 participants
n=299 Participants
|
|
Non-Cardiac Comorbidities
Diabetes (Type 1)
|
2 participants
n=299 Participants
|
|
Non-Cardiac Comorbidities
Diabetes (Type 2)
|
33 participants
n=299 Participants
|
|
Non-Cardiac Comorbidities
Hepatic Disease
|
5 participants
n=299 Participants
|
|
Non-Cardiac Comorbidities
Renal Disease
|
7 participants
n=299 Participants
|
|
Non-Cardiac Comorbidities
Gastrointestinal Disorder
|
42 participants
n=299 Participants
|
|
Non-Cardiac Comorbidities
Sleep Disordered Breathing
|
49 participants
n=299 Participants
|
|
Non-Cardiac Comorbidities
Other Non-Cardiac Co-Morbidities
|
85 participants
n=299 Participants
|
PRIMARY outcome
Timeframe: Up to 30 DaysPopulation: Of the 299 treatment subjects, a total of 13 primary safety events occurred through 30 days in 12 subjects.
The primary safety endpoint at 30 days is defined as the safety event-free rate at 1-Month (30 days) post-procedure.
Outcome measures
| Measure |
Treatment With Ablation Catheter
n=299 Participants
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
|
|---|---|
|
Rate of Primary Safety Events at 1-Month Post-Procedure
|
13 primary safety events
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: Of the 299 treatment subjects, a total of 13 primary safety events occurred through 12 months in 12 subjects.
The primary safety endpoint at 12 months is defined as the safety event-free rate at 12 months post-procedure.
Outcome measures
| Measure |
Treatment With Ablation Catheter
n=299 Participants
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
|
|---|---|
|
Rate of Primary Safety Events at 12-Months Post-Procedure
|
13 primary safety events
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: The freedom from primary effectiveness failure at 12 months is 60.5%.
The twelve-month effectiveness endpoint is defined as the event-free rate at twelve-month post-procedure.
Outcome measures
| Measure |
Treatment With Ablation Catheter
n=299 Participants
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
|
|---|---|
|
Percentage of Participants With Freedom From Treatment Failure at 12-Months Post-Procedure
|
181 Participants
|
PRIMARY outcome
Timeframe: 30 DaysPopulation: Acute procedural success was observed in 294 (98.3%) of the 299 Treatment subjects that underwent an ablation procedure.
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.
Outcome measures
| Measure |
Treatment With Ablation Catheter
n=299 Participants
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
|
|---|---|
|
Number of Participants That Achieved Electrical Isolation of All Pulmonary Veins
|
294 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: 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.
Secondary Safety Endpoint - AE Rates
Outcome measures
| Measure |
Treatment With Ablation Catheter
n=97 Participants
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
|
|---|---|
|
Rate of AEs Through 12-Months Post-Procedure
|
156 Events Reported
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Subjects were only counted as effectiveness failures if a new AAD or higher dose of a previously failed AAD continued after the blanking period.
Secondary Effectiveness Endpoint 1 - New or Increased Dose of AAD
Outcome measures
| Measure |
Treatment With Ablation Catheter
n=296 Participants
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
|
|---|---|
|
Number of Patients With New or Increased Dose of AAD
Subjects with New or Increased Dose of AAD
|
103 Participants
|
|
Number of Patients With New or Increased Dose of AAD
Subjects with No New or Increased Dose of AAD
|
193 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: 59% of subjects were free from primary effectiveness failure without a repeat procedure at 12-months.
Secondary Effectiveness Endpoint 2 - Single Procedure Success defined as freedom from primary effectiveness failure without a repeat procedure
Outcome measures
| Measure |
Treatment With Ablation Catheter
n=296 Participants
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
|
|---|---|
|
Percentage of Participants With Freedom From Primary Effectiveness Failure Without a Repeat Procedure
|
175 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: The freedom from documented arrhythmia recurrence, including atrial fibrillation (AF), atrial flutter (AFL), and atrial tachycardia (AT), was 71%.
Secondary Effectiveness Endpoint 3 - Symptomatic Recurrence: freedom from documented symptomatic AF/AT/AFL recurrence
Outcome measures
| Measure |
Treatment With Ablation Catheter
n=294 Participants
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
|
|---|---|
|
Percentage of Participants With Freedom From Documented Symptomatic Atrial Fibrillation, Atrial Flutter and Atrial Tachycardia Recurrence
|
211 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: 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.
Secondary Safety Endpoint - SAEs
Outcome measures
| Measure |
Treatment With Ablation Catheter
n=47 Participants
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
|
|---|---|
|
Rate of SAEs Through 12-Months Post-Procedure
|
72 Total number of reported SAEs
|
Adverse Events
Treatment With Ablation Catheter
Serious events: 47 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment With Ablation Catheter
n=299 participants at risk
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
|
|---|---|
|
Surgical and medical procedures
Atrial flutter, not specified
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Fistula (Arterial/Venous)
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Hemodynamic Instability
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Myocardial Perforation with Tamponade
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Oozing/Bleeding
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Pericardial Effusion
|
1.0%
3/299 • Number of events 3 • 12 months
|
|
Surgical and medical procedures
Pericarditis
|
2.0%
6/299 • Number of events 6 • 12 months
|
|
Surgical and medical procedures
Post procedure infection/sepsis
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Procedure related Abnormal labs
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Procedure related Allergic reactions/Adverse drug reaction
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Procedure related anesthesia/sedation
|
0.67%
2/299 • Number of events 2 • 12 months
|
|
Surgical and medical procedures
Procedure related Gastrointestinal
|
0.67%
2/299 • Number of events 2 • 12 months
|
|
Surgical and medical procedures
Procedure related Genitourinary/Renal
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Pseudoaneurysm
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Pulmonary Thromboembolism
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Pulmonary Edema
|
0.67%
2/299 • Number of events 2 • 12 months
|
|
Surgical and medical procedures
Right atrial (Type I) atrial flutter
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Sinus bradycardia
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Stroke
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Cardiac disorders
Atrial Fibrillation (AF)
|
1.3%
4/299 • Number of events 4 • 12 months
|
|
Cardiac disorders
Atrial Flutter
|
0.67%
2/299 • Number of events 2 • 12 months
|
|
Cardiac disorders
Atrial tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT)
|
0.33%
1/299 • Number of events 2 • 12 months
|
|
Cardiac disorders
Coronary artery disease
|
0.67%
2/299 • Number of events 2 • 12 months
|
|
Cardiac disorders
Dyspnea - Heart Failure
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Cardiac disorders
Heart Failure symptoms - Unspecified
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Cardiac disorders
Infection - Unrelated procedure/device
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Cardiac disorders
Multiple Symptoms
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Cardiac disorders
Ventricular Tachycardia (VT)/Monomorphic VT
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
General disorders
Abnormal laboratory values
|
0.67%
2/299 • Number of events 2 • 12 months
|
|
General disorders
Adverse reaction - Medication
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
General disorders
Cancer
|
0.67%
2/299 • Number of events 2 • 12 months
|
|
General disorders
Fever and/or virus
|
0.67%
2/299 • Number of events 2 • 12 months
|
|
General disorders
Gastrointestinal
|
1.0%
3/299 • Number of events 5 • 12 months
|
|
General disorders
Head, Eyes, Ears, Nose, Throat (HEENT)
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
General disorders
Hematological
|
0.67%
2/299 • Number of events 3 • 12 months
|
|
General disorders
Musculoskeletal
|
1.3%
4/299 • Number of events 4 • 12 months
|
|
General disorders
Neurological
|
0.67%
2/299 • Number of events 2 • 12 months
|
|
General disorders
Physical Trauma
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
General disorders
Psychological
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
General disorders
Pulmonary
|
1.3%
4/299 • Number of events 4 • 12 months
|
Other adverse events
| Measure |
Treatment With Ablation Catheter
n=299 participants at risk
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
|
|---|---|
|
Surgical and medical procedures
Angina/Chest pain
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Atrial Fibrillation (AF)
|
0.67%
2/299 • Number of events 2 • 12 months
|
|
Surgical and medical procedures
Atrial flutter, not specified
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Bleeding related to anticoagulation
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Edema
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Hematoma
|
0.67%
2/299 • Number of events 2 • 12 months
|
|
Surgical and medical procedures
Nerve Damage
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Oozing/Bleeding
|
1.0%
3/299 • Number of events 3 • 12 months
|
|
Surgical and medical procedures
Pain (Non-cardiovascular)
|
1.0%
3/299 • Number of events 3 • 12 months
|
|
Surgical and medical procedures
Pain cardiovascular (Non-ischemic)
|
1.0%
3/299 • Number of events 3 • 12 months
|
|
Surgical and medical procedures
Pericardial effusion
|
0.67%
2/299 • Number of events 2 • 12 months
|
|
Surgical and medical procedures
Pericarditis
|
5.4%
16/299 • Number of events 16 • 12 months
|
|
Surgical and medical procedures
Pleuritis
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Post procedure infection/sepsis
|
1.0%
3/299 • Number of events 3 • 12 months
|
|
Surgical and medical procedures
Post procedure wound discomfort
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Procedure related Allergic reactions/Adverse drug reaction
|
0.67%
2/299 • Number of events 2 • 12 months
|
|
Surgical and medical procedures
Procedure related Anesthesia/Sedation
|
1.0%
3/299 • Number of events 3 • 12 months
|
|
Surgical and medical procedures
Procedure related Gastrointestinal
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Procedure related Genitourinary/Renal
|
1.3%
4/299 • Number of events 4 • 12 months
|
|
Surgical and medical procedures
Procedure related Hypertension
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Procedure related Neurological (Non-TIA, non-stroke, dysphagia, speech disturbance/dysarthria)
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Procedure related Pulmonary (including cough, hemoptysis)
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Stroke
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Visual blurring/disturbances
|
0.67%
2/299 • Number of events 2 • 12 months
|
|
Cardiac disorders
Atrial Fibrillation (AF)
|
2.3%
7/299 • Number of events 8 • 12 months
|
|
Cardiac disorders
Atrial flutter
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Cardiac disorders
Chest pain - Other
|
0.67%
2/299 • Number of events 2 • 12 months
|
|
Cardiac disorders
Distal thromboemboli
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Cardiac disorders
Multiple Heart Failure symptoms
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Cardiac disorders
Multiple symptoms
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Cardiac disorders
Palpitations
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
Cardiac disorders
Sinus bradycardia
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
General disorders
Adverse reaction - Medication
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
General disorders
Fever and/or virus
|
1.7%
5/299 • Number of events 5 • 12 months
|
|
General disorders
Gastrointestinal
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
General disorders
Genitourinary
|
0.67%
2/299 • Number of events 2 • 12 months
|
|
General disorders
Hematological
|
0.33%
1/299 • Number of events 1 • 12 months
|
|
General disorders
Neurological
|
0.33%
1/299 • Number of events 1 • 12 months
|
Additional Information
Claire Dietzsch, Senior Clinical Trials Specialist
Boston Scientific
Phone: 9529306745
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place