Trial Outcomes & Findings for A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial Fibrillation (NCT NCT05443594)
NCT ID: NCT05443594
Last Updated: 2025-12-16
Results Overview
Phase 1: Through 7 Days: * Myocardial infarction * Stroke * Transient Ischemic Attack (TIA) * Peripheral or organ thromboembolism * Pulmonary edema * Unresolved phrenic nerve palsy / paresis * Vascular access complications * Heart block * Gastric motility / pyloric spasm disorders Through 30 Days: * Cardiac tamponade / perforation * Pericarditis Through 360 Days Post-Procedure: * PV stenosis * Atrio-esophageal fistula Phase 2 Through 7 Days: * Myocardial infarction * Stroke * Transient Ischemic Attack (TIA) * Peripheral or organ thromboembolism * Pulmonary edema * Unresolved phrenic nerve palsy / paresis * Vascular access complications * Heart block * Gastric motility / pyloric spasm disorders Through 30 Days: * Death * Cardiac tamponade / perforation * Pericarditis * Any PFA system related PFA procedure-related cardiovascular or pulmonary adverse event Through 90 Days: * PV stenosis * Atrio-esophageal fistula
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
669 participants
Primary outcome timeframe
Phase 1 Index Procedure through 360 Days | Phase 2 Index Procedure through 90 Days (per protocol Primary Safety Endpoint requirements)
Results posted on
2025-12-16
Participant Flow
Participant milestones
| Measure |
Pulsed Field Ablation (Phase 1)
PHASE 1 only
Phase 1: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter.
|
Pulse Field Ablation (Phase 2)
Phase 2 only
Phase 2: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter and FARAPOINT PFA Catheter for cavo-tricuspid isthmus (CTI) ablation.
|
|---|---|---|
|
Overall Study
STARTED
|
355
|
314
|
|
Overall Study
COMPLETED
|
325
|
290
|
|
Overall Study
NOT COMPLETED
|
30
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
Pulsed Field Ablation (Phase 1) Non-Roll In Treatment Subjects
n=260 Participants
PHASE 1 only
Phase 1: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter.
|
Pulsed Field Ablation (Phase 2) Non-Roll In Treatment Subjects
n=255 Participants
Phase 2 only
Phase 2: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter and FARAPOINT PFA Catheter for cavo-tricuspid isthmus (CTI) ablation.
|
Total
n=515 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.2 years
STANDARD_DEVIATION 9.3 • n=6 Participants
|
66.7 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
66.4 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=6 Participants
|
73 Participants
n=5 Participants
|
153 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
180 Participants
n=6 Participants
|
182 Participants
n=5 Participants
|
362 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=6 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
211 Participants
n=6 Participants
|
245 Participants
n=5 Participants
|
456 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
45 Participants
n=6 Participants
|
5 Participants
n=5 Participants
|
50 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=6 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=6 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
209 Participants
n=6 Participants
|
241 Participants
n=5 Participants
|
450 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Report
|
45 Participants
n=6 Participants
|
5 Participants
n=5 Participants
|
50 Participants
n=5 Participants
|
|
Height (cm)
|
175.8 cm
STANDARD_DEVIATION 9.7 • n=6 Participants
|
177.6 cm
STANDARD_DEVIATION 10.6 • n=5 Participants
|
176.7 cm
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Weight (kg)
|
94.3 kg
STANDARD_DEVIATION 19.7 • n=6 Participants
|
98 kg
STANDARD_DEVIATION 20.3 • n=5 Participants
|
96.1 kg
STANDARD_DEVIATION 20.1 • n=5 Participants
|
|
BMI (kg/m^2)
|
30.4 kg/m^2
STANDARD_DEVIATION 5.3 • n=6 Participants
|
30.9 kg/m^2
STANDARD_DEVIATION 5.3 • n=5 Participants
|
30.7 kg/m^2
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
Resting Heart Rate (bpm)
|
74 bpm
STANDARD_DEVIATION 18.3 • n=6 Participants
|
76.8 bpm
STANDARD_DEVIATION 18.7 • n=5 Participants
|
75.4 bpm
STANDARD_DEVIATION 18.5 • n=5 Participants
|
|
Systolic Blood Pressure (mmHg)
|
129.9 mmHg
STANDARD_DEVIATION 16.6 • n=6 Participants
|
129.8 mmHg
STANDARD_DEVIATION 16.6 • n=5 Participants
|
129.8 mmHg
STANDARD_DEVIATION 16.6 • n=5 Participants
|
|
Diastolic Blood Pressure (mmHg)
|
77.5 mmHg
STANDARD_DEVIATION 10.0 • n=6 Participants
|
77.6 mmHg
STANDARD_DEVIATION 10.3 • n=5 Participants
|
77.5 mmHg
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Left Ventricular Ejection Fraction (%)
|
57.2 % blood ejected from the left ventricle
STANDARD_DEVIATION 6.9 • n=6 Participants
|
56.6 % blood ejected from the left ventricle
STANDARD_DEVIATION 6.7 • n=5 Participants
|
56.9 % blood ejected from the left ventricle
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
LA Diameter (cm)
|
4.3 cm
STANDARD_DEVIATION 0.6 • n=6 Participants
|
4.3 cm
STANDARD_DEVIATION 0.6 • n=5 Participants
|
4.3 cm
STANDARD_DEVIATION 0.6 • n=5 Participants
|
|
LA Volume (mL)
|
65.1 mL
STANDARD_DEVIATION 24.6 • n=6 Participants
|
65.5 mL
STANDARD_DEVIATION 19.3 • n=5 Participants
|
65.2 mL
STANDARD_DEVIATION 23.0 • n=5 Participants
|
|
NYHA
No Heart Failure
|
173 participants
n=6 Participants
|
140 participants
n=5 Participants
|
313 participants
n=5 Participants
|
|
NYHA
Class I
|
42 participants
n=6 Participants
|
52 participants
n=5 Participants
|
94 participants
n=5 Participants
|
|
NYHA
Class II
|
44 participants
n=6 Participants
|
63 participants
n=5 Participants
|
107 participants
n=5 Participants
|
|
NYHA
Class III
|
0 participants
n=6 Participants
|
0 participants
n=5 Participants
|
0 participants
n=5 Participants
|
|
NYHA
Class IV
|
0 participants
n=6 Participants
|
0 participants
n=5 Participants
|
0 participants
n=5 Participants
|
|
CHA₂DS₂-VASc Score
1
|
47 Participants
n=6 Participants
|
46 Participants
n=5 Participants
|
93 Participants
n=5 Participants
|
|
CHA₂DS₂-VASc Score
2
|
59 Participants
n=6 Participants
|
68 Participants
n=5 Participants
|
127 Participants
n=5 Participants
|
|
CHA₂DS₂-VASc Score
3
|
64 Participants
n=6 Participants
|
65 Participants
n=5 Participants
|
129 Participants
n=5 Participants
|
|
CHA₂DS₂-VASc Score
4
|
43 Participants
n=6 Participants
|
37 Participants
n=5 Participants
|
80 Participants
n=5 Participants
|
|
CHA₂DS₂-VASc Score
5
|
12 Participants
n=6 Participants
|
16 Participants
n=5 Participants
|
28 Participants
n=5 Participants
|
|
CHA₂DS₂-VASc Score
6
|
4 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
|
CHA₂DS₂-VASc Score
7
|
0 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
CHA₂DS₂-VASc Score
0
|
31 Participants
n=6 Participants
|
21 Participants
n=5 Participants
|
52 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Phase 1 Index Procedure through 360 Days | Phase 2 Index Procedure through 90 Days (per protocol Primary Safety Endpoint requirements)Population: Adverse Events reported for subjects were reviewed and adjudicated for meeting Safety Endpoint criteria by an independent physician Clinical Events Committee.
Phase 1: Through 7 Days: * Myocardial infarction * Stroke * Transient Ischemic Attack (TIA) * Peripheral or organ thromboembolism * Pulmonary edema * Unresolved phrenic nerve palsy / paresis * Vascular access complications * Heart block * Gastric motility / pyloric spasm disorders Through 30 Days: * Cardiac tamponade / perforation * Pericarditis Through 360 Days Post-Procedure: * PV stenosis * Atrio-esophageal fistula Phase 2 Through 7 Days: * Myocardial infarction * Stroke * Transient Ischemic Attack (TIA) * Peripheral or organ thromboembolism * Pulmonary edema * Unresolved phrenic nerve palsy / paresis * Vascular access complications * Heart block * Gastric motility / pyloric spasm disorders Through 30 Days: * Death * Cardiac tamponade / perforation * Pericarditis * Any PFA system related PFA procedure-related cardiovascular or pulmonary adverse event Through 90 Days: * PV stenosis * Atrio-esophageal fistula
Outcome measures
| Measure |
Pulsed Field Ablation (Phase 1) Non-Roll In Treatment Subjects
n=260 Participants
PHASE 1 only
Phase 1: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter.
|
Pulsed Field Ablation (Phase 2) Non-Roll In Treatment Subjects
n=255 Participants
Phase 2 only
Phase 2: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter and FARAPOINT PFA Catheter for cavo-tricuspid isthmus (CTI) ablation.
|
|---|---|---|
|
Primary Safety Endpoint (PSE): Event Rate of Safety Events Post Procedure
|
2.3 Percentage of participants
Interval to 5.1
One sided confidence interval
|
2.4 Percentage of participants
Interval to 5.2
One sided confidence interval
|
PRIMARY outcome
Timeframe: Post-Blanking Period: Day 90 through Day 360Population: Note: Phase 1 includes all Non-Roll in Treatment subjects. Phase 2 includes Non-Roll in Treatment subjects who received an Insertable Cardiac Monitor for arrhythmia recurrence monitoring.
Includes both Acute Procedural Success and Chronic Success through Day 360.
Outcome measures
| Measure |
Pulsed Field Ablation (Phase 1) Non-Roll In Treatment Subjects
n=260 Participants
PHASE 1 only
Phase 1: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter.
|
Pulsed Field Ablation (Phase 2) Non-Roll In Treatment Subjects
n=253 Participants
Phase 2 only
Phase 2: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter and FARAPOINT PFA Catheter for cavo-tricuspid isthmus (CTI) ablation.
|
|---|---|---|
|
Primary Effectiveness Endpoint: Treatment Success Rate Through Day 360
|
63.5 Percentage of participants
Interval 57.3 to
One-sided confidence interval
|
73.4 Percentage of participants
Interval 67.5 to
One-sided confidence interval
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post-Blanking Period: Day 90 through Day 360Population: Note: Phase 1 includes all Non-Roll in Treatment subjects. Phase 2 includes Non-Roll in Treatment subjects who received an Insertable Cardiac Monitor for arrhythmia recurrence monitoring.
Defined as the freedom from any of the following through the Day 360 Assessment after the Blanking Period, excluding documented CTI-dependent AFL for phase 1 and for Phase 2 excluding documented CTI-dependent AFL if the participant did not have a CTI ablation with a FARAPOINT PFA Catheter: 1. Arrhythmia: Occurrence of any Detectable AF, AFL or AT 2. Re-ablation: Any re-ablation for AF, AFL or AT 3. Cardioversion: Any electrical cardioversion for AF, AFL or AT 4. AAD Use: Use of a Non-Failed Class I / III AAD or amiodarone
Outcome measures
| Measure |
Pulsed Field Ablation (Phase 1) Non-Roll In Treatment Subjects
n=260 Participants
PHASE 1 only
Phase 1: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter.
|
Pulsed Field Ablation (Phase 2) Non-Roll In Treatment Subjects
n=253 Participants
Phase 2 only
Phase 2: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter and FARAPOINT PFA Catheter for cavo-tricuspid isthmus (CTI) ablation.
|
|---|---|---|
|
Rate of Persistent AF Chronic Success
|
64.2 Percentage of participants
Interval 58.1 to 70.1
|
73.4 Percentage of participants
Interval 67.5 to 78.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed through Index Ablation ProcedurePopulation: Note: Phase 1 includes all Non-Roll in Treatment subjects. Phase 2 includes Non-Roll in Treatment subjects who received an Insertable Cardiac Monitor for arrhythmia recurrence monitoring.
* The isolation of all attempted PVs as clinically assessed at the end of the procedure by entrance block performed with or without adenosine testing, AND * The isolation of the left atrial PW as clinically assessed at the end of the procedure, performed with or without adenosine testing, via interrogation by multipolar diagnostic catheter or 3D electroanatomical mapping. * Use of an ablation catheter other than the FARAWAVE Pulse Field Ablation Catheter (i.e., use of a non-study catheter) to achieve Pulmonary Vein Isolation and Posterior Wall Isolation.
Outcome measures
| Measure |
Pulsed Field Ablation (Phase 1) Non-Roll In Treatment Subjects
n=260 Participants
PHASE 1 only
Phase 1: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter.
|
Pulsed Field Ablation (Phase 2) Non-Roll In Treatment Subjects
n=253 Participants
Phase 2 only
Phase 2: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter and FARAPOINT PFA Catheter for cavo-tricuspid isthmus (CTI) ablation.
|
|---|---|---|
|
Rate of Persistent AF Acute Procedural Success
|
99.6 Percentage of participants
Interval 97.9 to 100.0
|
99.6 Percentage of participants
Interval 97.8 to 100.0
|
POST_HOC outcome
Timeframe: Post-Blanking Period: Day 90 through Day 360Population: Note: Freedom from Documented Symptomatic Recurrence and Intervention was a post-hoc analysis for the Phase 1 cohort and a pre-specified analysis for the Phase 2 cohort. Note: Phase 1 includes all Non-Roll in Treatment subjects. Phase 2 includes Non-Roll in Treatment subjects who received an Insertable Cardiac Monitor for arrhythmia recurrence monitoring.
Freedom from symptomatic recurrence and intervention is Chronic Treatment Success, as defined for the Primary Effectiveness Endpoint, but excluding failure due to asymptomatic detectable AF, AFL, or AT.
Outcome measures
| Measure |
Pulsed Field Ablation (Phase 1) Non-Roll In Treatment Subjects
n=260 Participants
PHASE 1 only
Phase 1: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter.
|
Pulsed Field Ablation (Phase 2) Non-Roll In Treatment Subjects
n=253 Participants
Phase 2 only
Phase 2: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter and FARAPOINT PFA Catheter for cavo-tricuspid isthmus (CTI) ablation.
|
|---|---|---|
|
Freedom From Documented Symptomatic Recurrence and Intervention
|
85.3 Percentage of participants
Interval 80.3 to
One sided confidence interval
|
81.0 Percentage of participants
Interval 75.5 to 85.3
|
Adverse Events
Pulsed Field Ablation (Phase 1) Non-Roll In Treatment Subjects
Serious events: 44 serious events
Other events: 82 other events
Deaths: 0 deaths
Pulsed Field Ablation (Phase 2) Non-Roll In Treatment Subjects
Serious events: 53 serious events
Other events: 76 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Pulsed Field Ablation (Phase 1) Non-Roll In Treatment Subjects
n=260 participants at risk
PHASE 1 only
Phase 1: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter.
|
Pulsed Field Ablation (Phase 2) Non-Roll In Treatment Subjects
n=255 participants at risk
Phase 2 only
Phase 2: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter and FARAPOINT PFA Catheter for cavo-tricuspid isthmus (CTI) ablation.
|
|---|---|---|
|
Infections and infestations
Localized infection
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
General disorders
Physical Trauma
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
General disorders
Pleural effusion - unrelated procedure/ device
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Infections and infestations
Post procedure infection/ sepsis
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Surgical and medical procedures
Procedure related Anesthesia/ sedation
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Surgical and medical procedures
Procedure related Genitourinary/ renal
|
1.5%
4/260 • Number of events 4 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Surgical and medical procedures
Procedure related heart failure
|
1.2%
3/260 • Number of events 3 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Surgical and medical procedures
Procedure related hypotension
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Surgical and medical procedures
Procedure related Neurological (Non-TIA, non-stroke, dysphagia, speech disturbance/ dysarthria)
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Surgical and medical procedures
Procedure related Pulmonary (including cough, hemoptysis)
|
0.77%
2/260 • Number of events 2 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Psychiatric disorders
Psychological
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Cardiac disorders
ST segment elevation
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Cardiac disorders
Syncope
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Cardiac disorders
Thrombus
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Cardiac disorders
Valvular damage/ valvular insufficiency
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Cardiac disorders
AV block (Transient)
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
General disorders
Chest pain - Other
|
0.00%
0/260 • Through Day 360
|
0.78%
2/255 • Number of events 2 • Through Day 360
|
|
Cardiac disorders
Dyspnea - Heart Failure
|
0.00%
0/260 • Through Day 360
|
0.78%
2/255 • Number of events 2 • Through Day 360
|
|
Injury, poisoning and procedural complications
Embolism - Air
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
General disorders
Head, Eyes, Ears, Nose, Throat (HEENT)
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 2 • Through Day 360
|
|
Injury, poisoning and procedural complications
Hemolysis (laboratory confirmed)
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Injury, poisoning and procedural complications
Hemolysis high suspicion
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 2 • Through Day 360
|
|
Vascular disorders
Hypertension/Hypertensive crisis
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Vascular disorders
Hypotension/Orthostatic hypotension
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Cardiac disorders
Impaired Mobility
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Infections and infestations
Infection - Unrelated procedure/device
|
0.00%
0/260 • Through Day 360
|
0.78%
2/255 • Number of events 2 • Through Day 360
|
|
Injury, poisoning and procedural complications
Major bleeding/Hemorrhage requiring transfusion
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
0.00%
0/260 • Through Day 360
|
2.0%
5/255 • Number of events 5 • Through Day 360
|
|
Vascular disorders
Myocardial infarction
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Injury, poisoning and procedural complications
Myocardial perforation with tamponade
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Nervous system disorders
Neurological
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Cardiac disorders
Pericardial effusion - Unrelated procedure/device
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Injury, poisoning and procedural complications
Post-surgical pocket hemorrhage/bleeding/drainage
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Injury, poisoning and procedural complications
Procedure related Abnormal labs
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Injury, poisoning and procedural complications
Procedure related Fatigue/Weakness
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Injury, poisoning and procedural complications
Procedure related Genitourinary
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Injury, poisoning and procedural complications
Procedure related Renal
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
0.00%
0/260 • Through Day 360
|
0.78%
2/255 • Number of events 3 • Through Day 360
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/260 • Through Day 360
|
2.0%
5/255 • Number of events 5 • Through Day 360
|
|
Injury, poisoning and procedural complications
Stroke
|
0.00%
0/260 • Through Day 360
|
0.78%
2/255 • Number of events 2 • Through Day 360
|
|
General disorders
Vasovagal reaction
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Gastrointestinal disorders
Gastrointestinal
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
1.6%
4/255 • Number of events 5 • Through Day 360
|
|
Renal and urinary disorders
Genitourinary
|
1.2%
3/260 • Number of events 4 • Through Day 360
|
0.78%
2/255 • Number of events 2 • Through Day 360
|
|
Vascular disorders
Hematoma - Unrelated procedure/device
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Cardiac disorders
2nd degree AV block
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Surgical and medical procedures
Abnormal laboratory values
|
1.2%
3/260 • Number of events 3 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Surgical and medical procedures
Adverse reaction-Medication
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.78%
2/255 • Number of events 2 • Through Day 360
|
|
Cardiac disorders
Atrial Fibrillation
|
3.5%
9/260 • Number of events 10 • Through Day 360
|
3.9%
10/255 • Number of events 11 • Through Day 360
|
|
Cardiac disorders
Atrial Flutter
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
1.2%
3/255 • Number of events 3 • Through Day 360
|
|
Cardiac disorders
Atrial tachycardia/ Other SVT (AVRT, AVNRT, EAT)
|
0.77%
2/260 • Number of events 2 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Infections and infestations
Cancer
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Nervous system disorders
Cerebrovascular Accident (CVA)
|
0.77%
2/260 • Number of events 2 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Nervous system disorders
Cerebrovascular Accident (CVA)- Hemorrhagic
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.78%
2/255 • Number of events 2 • Through Day 360
|
|
Cardiac disorders
Coronary artery Disease
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.78%
2/255 • Number of events 2 • Through Day 360
|
|
Cardiac disorders
Coronary artery injury/ spasm
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Cardiac disorders
Dyspnea
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
General disorders
Exacerbation of existing condition
|
0.77%
2/260 • Number of events 2 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Cardiac disorders
Fluid volume overload
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
Other adverse events
| Measure |
Pulsed Field Ablation (Phase 1) Non-Roll In Treatment Subjects
n=260 participants at risk
PHASE 1 only
Phase 1: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter.
|
Pulsed Field Ablation (Phase 2) Non-Roll In Treatment Subjects
n=255 participants at risk
Phase 2 only
Phase 2: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter and FARAPOINT PFA Catheter for cavo-tricuspid isthmus (CTI) ablation.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Post surgical wound discomfort/bruising/swelling
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Injury, poisoning and procedural complications
Post-surgical pocket hemorrhage/bleeding/drainage
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Injury, poisoning and procedural complications
Procedure related Abnormal labs
|
0.77%
2/260 • Number of events 3 • Through Day 360
|
1.6%
4/255 • Number of events 4 • Through Day 360
|
|
Injury, poisoning and procedural complications
Procedure related Allergic reactions/Adverse drug reaction
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Injury, poisoning and procedural complications
Procedure related Anesthesia/Sedation
|
4.2%
11/260 • Number of events 14 • Through Day 360
|
0.78%
2/255 • Number of events 2 • Through Day 360
|
|
Injury, poisoning and procedural complications
Procedure related Gastrointestinal
|
1.2%
3/260 • Number of events 3 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Injury, poisoning and procedural complications
Procedure related Genitourinary
|
0.00%
0/260 • Through Day 360
|
0.78%
2/255 • Number of events 2 • Through Day 360
|
|
Injury, poisoning and procedural complications
Procedure related Genitourinary/Renal
|
5.0%
13/260 • Number of events 13 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Injury, poisoning and procedural complications
Procedure related Heart Failure
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Injury, poisoning and procedural complications
Procedure related Hypertension
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Injury, poisoning and procedural complications
Procedure related Hypotension
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
1.2%
3/255 • Number of events 3 • Through Day 360
|
|
General disorders
Cancer
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Renal and urinary disorders
Genitourinary
|
1.2%
3/260 • Number of events 3 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Infections and infestations
Localized infection
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
General disorders
Physical trauma
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Psychiatric disorders
Psychological
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
0.77%
2/260 • Number of events 2 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Cardiac disorders
1st degree AV block
|
0.00%
0/260 • Through Day 360
|
0.78%
2/255 • Number of events 2 • Through Day 360
|
|
General disorders
Adverse reaction - Medication
|
0.00%
0/260 • Through Day 360
|
0.78%
2/255 • Number of events 2 • Through Day 360
|
|
Injury, poisoning and procedural complications
Angina/Chest pain
|
0.77%
2/260 • Number of events 2 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Cardiac disorders
Atrial flutter, not specified
|
1.2%
3/260 • Number of events 3 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Injury, poisoning and procedural complications
Bruising access site
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
2.4%
6/255 • Number of events 6 • Through Day 360
|
|
Vascular disorders
Cerebrovascular Accident (CVA) - Hemorrhagic
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
General disorders
Chest pain - Ischemic
|
0.77%
2/260 • Number of events 2 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
General disorders
Dizziness
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Injury, poisoning and procedural complications
Edema
|
0.77%
2/260 • Number of events 2 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Product Issues
Erosion
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Infections and infestations
Fever and/or virus
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Injury, poisoning and procedural complications
Fluid volume overload
|
0.77%
2/260 • Number of events 2 • Through Day 360
|
2.0%
5/255 • Number of events 5 • Through Day 360
|
|
Gastrointestinal disorders
Gastrointestinal
|
0.00%
0/260 • Through Day 360
|
1.2%
3/255 • Number of events 3 • Through Day 360
|
|
Injury, poisoning and procedural complications
Headache
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Cardiac disorders
Heart Failure symptoms - Unspecified
|
0.00%
0/260 • Through Day 360
|
1.2%
3/255 • Number of events 3 • Through Day 360
|
|
Blood and lymphatic system disorders
Hematological
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Injury, poisoning and procedural complications
Hematoma
|
3.1%
8/260 • Number of events 8 • Through Day 360
|
1.6%
4/255 • Number of events 4 • Through Day 360
|
|
Injury, poisoning and procedural complications
Hemolysis (Laboratory confirmed)
|
0.77%
2/260 • Number of events 2 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
General disorders
Hernia
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Injury, poisoning and procedural complications
Hiccups
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Injury, poisoning and procedural complications
Inadequate healing of incision site
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
0.00%
0/260 • Through Day 360
|
0.78%
2/255 • Number of events 2 • Through Day 360
|
|
Cardiac disorders
Non-Sustained Ventricular Tachycardia (NSVT)
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Injury, poisoning and procedural complications
Non-symptomatic pericardial effusion
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Injury, poisoning and procedural complications
Oozing/Bleeding
|
2.7%
7/260 • Number of events 7 • Through Day 360
|
3.9%
10/255 • Number of events 10 • Through Day 360
|
|
Injury, poisoning and procedural complications
Pain (Non-cardiovascular)
|
1.9%
5/260 • Number of events 5 • Through Day 360
|
0.78%
2/255 • Number of events 2 • Through Day 360
|
|
Injury, poisoning and procedural complications
Pain cardiovascular (Non-ischemic)
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
1.2%
3/255 • Number of events 3 • Through Day 360
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Injury, poisoning and procedural complications
Pericarditis
|
0.00%
0/260 • Through Day 360
|
0.78%
2/255 • Number of events 2 • Through Day 360
|
|
Injury, poisoning and procedural complications
Phrenic nerve injury temporary
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Injury, poisoning and procedural complications
Pleural effusion
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Injury, poisoning and procedural complications
Post procedure infection/sepsis
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Injury, poisoning and procedural complications
Post procedure wound discomfort
|
1.5%
4/260 • Number of events 4 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Injury, poisoning and procedural complications
Post -surgical infection (<=30 days post implant)
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Cardiac disorders
Syncope
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
General disorders
Edema
|
0.77%
2/260 • Number of events 2 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Cardiac disorders
AV block (permanent)
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Cardiac disorders
Atrial Fibrillation
|
4.2%
11/260 • Number of events 13 • Through Day 360
|
3.1%
8/255 • Number of events 8 • Through Day 360
|
|
Cardiac disorders
Atrial flutter
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Cardiac disorders
Atrial tachycardia/ Other SVT(AVRT, AVNRT, EAT)
|
1.2%
3/260 • Number of events 3 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Vascular disorders
Chest pain - Ischemic
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
General disorders
Fatigue/ weakness
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Cardiac disorders
Hypertension/ hypertensive crisis
|
0.77%
2/260 • Number of events 2 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Cardiac disorders
Multiple heart failure symptoms
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
General disorders
Peripheral edema - Heart Failure
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Cardiac disorders
Sinus bradycardia
|
0.77%
2/260 • Number of events 2 • Through Day 360
|
2.4%
6/255 • Number of events 6 • Through Day 360
|
|
Injury, poisoning and procedural complications
Procedure related Neurological (Non-TIA, non-stroke, dysphagia, speech disturbance/dysarthria)
|
1.5%
4/260 • Number of events 4 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Injury, poisoning and procedural complications
Procedure related Pulmonary (including cough, hemoptysis)
|
0.77%
2/260 • Number of events 2 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Injury, poisoning and procedural complications
Pulmonary edema
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Injury, poisoning and procedural complications
Stroke
|
0.00%
0/260 • Through Day 360
|
0.39%
1/255 • Number of events 1 • Through Day 360
|
|
Injury, poisoning and procedural complications
Symptomatic pericardial effusion
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Injury, poisoning and procedural complications
Vasovagal
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
|
Injury, poisoning and procedural complications
Visual blurring/disturbances, Migraine
|
0.38%
1/260 • Number of events 1 • Through Day 360
|
0.00%
0/255 • Through Day 360
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place