Trial Outcomes & Findings for The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation (NCT NCT04612244)
NCT ID: NCT04612244
Last Updated: 2024-11-20
Results Overview
Proportion of Intent to Treat subjects with one or more of the specified device or procedure related SAEs
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
706 participants
Primary outcome timeframe
7 days and 12 Months
Results posted on
2024-11-20
Participant Flow
There were 80 Roll-in subjects and 19 randomized subjects (ITT) that withdrew before the procedure.
Unit of analysis: procedures
Participant milestones
| Measure |
FARAPULSE Pulsed Field Ablation System
FARAPULSE Pulsed Field Ablation System: Ablation using the FARAPULSE Pulsed Field Ablation System
|
Force Sensing Radiofrequency Ablation and Cryoballoon Ablation
Radiofrequency and Cryoballoon Ablation: Contact Force Enabled RF and Cryoballoon ablation catheters indicated for Paroxysmal Atrial Fibrillation
|
|---|---|---|
|
Overall Study
STARTED
|
305 305
|
302 302
|
|
Overall Study
COMPLETED
|
293 293
|
290 290
|
|
Overall Study
NOT COMPLETED
|
12 12
|
12 12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
FARAPULSE Pulsed Field Ablation System
n=305 Participants
FARAPULSE Pulsed Field Ablation System: Ablation using the FARAPULSE Pulsed Field Ablation System
|
Force Sensing Radiofrequency Ablation and Cryoballoon Ablation
n=302 Participants
Radiofrequency and Cryoballoon Ablation: Contact Force Enabled RF and Cryoballoon ablation catheters indicated for Paroxysmal Atrial Fibrillation
|
Total
n=607 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.4 years
n=5 Participants
|
62.5 years
n=7 Participants
|
62.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
202 Participants
n=5 Participants
|
195 Participants
n=7 Participants
|
397 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
297 Participants
n=5 Participants
|
299 Participants
n=7 Participants
|
596 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
286 Participants
n=5 Participants
|
272 Participants
n=7 Participants
|
558 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
305 Participants
n=5 Participants
|
302 Participants
n=7 Participants
|
607 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 days and 12 MonthsPopulation: MITT
Proportion of Intent to Treat subjects with one or more of the specified device or procedure related SAEs
Outcome measures
| Measure |
FARAPULSE Pulsed Field Ablation System
n=305 Participants
FARAPULSE Pulsed Field Ablation System: Ablation using the FARAPULSE Pulsed Field Ablation System
|
Force Sensing Radiofrequency Ablation and Cryoballoon Ablation
n=302 Participants
Radiofrequency and Cryoballoon Ablation: Contact Force Enabled RF and Cryoballoon ablation catheters indicated for Paroxysmal Atrial Fibrillation
|
|---|---|---|
|
Composite Safety Endpoint;Proportion of MITT Subjects With One or More of the Specified Device or Procedure Related SAEs
|
6 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 12-MonthsPopulation: MITT
Treatment Success: The primary effectiveness endpoint is Treatment Success in MITT Subjects, defined as: 1. Acute Procedural Success AND 2. Chronic Success, defined as freedom from: 1. At the Index / Rescheduled Index Procedure: Use of a non-randomized treatment modality for PVI 2. After the Blanking Period: i. Occurrence of any Detectable AF, AFL or AT (excluding CTI-dependent flutter confirmed by EP study) ii. Any cardioversion for AF, AFL or AT (excluding for CTI-dependent flutter) iii. Use of any Type I or Type III antiarrhythmic medication for the treatment of AF, AFL or AT c. At any time: i. Re-ablation for AF, AFL or AT (other than for CTI-dependent flutter) ii. Use of amiodarone, except intra-procedurally to control an arrhythmia Endpoint status will be assessed through the Month 12 Assessment (Day 360 ± 30).
Outcome measures
| Measure |
FARAPULSE Pulsed Field Ablation System
n=305 Participants
FARAPULSE Pulsed Field Ablation System: Ablation using the FARAPULSE Pulsed Field Ablation System
|
Force Sensing Radiofrequency Ablation and Cryoballoon Ablation
n=302 Participants
Radiofrequency and Cryoballoon Ablation: Contact Force Enabled RF and Cryoballoon ablation catheters indicated for Paroxysmal Atrial Fibrillation
|
|---|---|---|
|
Primary Effectiveness Endpoint
|
204 Participants
|
194 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: MITT
Mean change in aggregate PV Cross-Sectional area (cm\^2) from baseline to Day 90
Outcome measures
| Measure |
FARAPULSE Pulsed Field Ablation System
n=259 Participants
FARAPULSE Pulsed Field Ablation System: Ablation using the FARAPULSE Pulsed Field Ablation System
|
Force Sensing Radiofrequency Ablation and Cryoballoon Ablation
n=255 Participants
Radiofrequency and Cryoballoon Ablation: Contact Force Enabled RF and Cryoballoon ablation catheters indicated for Paroxysmal Atrial Fibrillation
|
|---|---|---|
|
Change in PV Cross-sectional Area
|
-0.18 cm^2.
Interval -0.37 to 0.0
|
-1.18 cm^2.
Interval -1.39 to -0.97
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: MITT
The secondary effectiveness endpoint is the same as the primary effectiveness endpoint but will be tested for superiority rather than non-inferiority. The proportion of Pulsed Field Subjects with Treatment Success will be assessed for superiority to the proportion of Thermal Subjects with Treatment Success.
Outcome measures
| Measure |
FARAPULSE Pulsed Field Ablation System
n=305 Participants
FARAPULSE Pulsed Field Ablation System: Ablation using the FARAPULSE Pulsed Field Ablation System
|
Force Sensing Radiofrequency Ablation and Cryoballoon Ablation
n=302 Participants
Radiofrequency and Cryoballoon Ablation: Contact Force Enabled RF and Cryoballoon ablation catheters indicated for Paroxysmal Atrial Fibrillation
|
|---|---|---|
|
Primary Effectiveness Treatment Success Tested for Superiority
|
73.3 Treatment Success Rate
Interval 68.1 to 78.1
|
71.3 Treatment Success Rate
Interval 66.0 to 76.3
|
Adverse Events
FARAPULSE Pulsed Field Ablation System
Serious events: 37 serious events
Other events: 88 other events
Deaths: 2 deaths
Force Sensing Radiofrequency Ablation and Cryoballoon Ablation
Serious events: 34 serious events
Other events: 103 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
FARAPULSE Pulsed Field Ablation System
n=305 participants at risk
FARAPULSE Pulsed Field Ablation System: Ablation using the FARAPULSE Pulsed Field Ablation System
|
Force Sensing Radiofrequency Ablation and Cryoballoon Ablation
n=302 participants at risk
Radiofrequency and Cryoballoon Ablation: Contact Force Enabled RF and Cryoballoon ablation catheters indicated for Paroxysmal Atrial Fibrillation
|
|---|---|---|
|
Blood and lymphatic system disorders
Patient Condition-Non Cardiovascular-Other
|
0.00%
0/305 • 420 days
|
0.33%
1/302 • Number of events 2 • 420 days
|
|
Cardiac disorders
Atrial Fibrillation
|
2.0%
6/305 • Number of events 7 • 420 days
|
3.0%
9/302 • Number of events 11 • 420 days
|
|
Cardiac disorders
Atrial Flutter
|
0.66%
2/305 • Number of events 3 • 420 days
|
0.33%
1/302 • Number of events 1 • 420 days
|
|
Cardiac disorders
Atrial Flutter-Not Specified
|
0.33%
1/305 • Number of events 1 • 420 days
|
0.33%
1/302 • Number of events 1 • 420 days
|
|
Cardiac disorders
Atrial Tachycardia Other SVT
|
0.00%
0/305 • 420 days
|
0.33%
1/302 • Number of events 1 • 420 days
|
|
Cardiac disorders
Atypical (Type II) Atrial Flutter
|
0.33%
1/305 • Number of events 2 • 420 days
|
0.33%
1/302 • Number of events 1 • 420 days
|
|
Cardiac disorders
Cardiac Arrest
|
0.33%
1/305 • Number of events 1 • 420 days
|
0.00%
0/302 • 420 days
|
|
Cardiac disorders
Cardiac Tamponade- Unrelated to Procedure/Device
|
0.00%
0/305 • 420 days
|
0.33%
1/302 • Number of events 1 • 420 days
|
|
Cardiac disorders
Chest Pain Other
|
0.33%
1/305 • Number of events 1 • 420 days
|
0.00%
0/302 • 420 days
|
|
Cardiac disorders
Conduction Disturbances/ Arrhythmia-Other
|
0.33%
1/305 • Number of events 2 • 420 days
|
0.00%
0/302 • 420 days
|
|
Cardiac disorders
Coronary Artery Disease
|
0.33%
1/305 • Number of events 1 • 420 days
|
0.00%
0/302 • 420 days
|
|
Cardiac disorders
Left Atrial (Type II, Atypical) Atrial Flutter
|
0.00%
0/305 • 420 days
|
0.33%
1/302 • Number of events 1 • 420 days
|
|
Cardiac disorders
Myocardial Perforation with Tamponade
|
0.66%
2/305 • Number of events 2 • 420 days
|
0.00%
0/302 • 420 days
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/305 • 420 days
|
0.33%
1/302 • Number of events 1 • 420 days
|
|
Cardiac disorders
SinuasBradycardia
|
0.00%
0/305 • 420 days
|
0.66%
2/302 • Number of events 2 • 420 days
|
|
Cardiac disorders
Symptomatic Pericardial Effusion
|
0.33%
1/305 • Number of events 1 • 420 days
|
0.00%
0/302 • 420 days
|
|
Congenital, familial and genetic disorders
Intracardiac Thrombus
|
0.33%
1/305 • Number of events 1 • 420 days
|
0.00%
0/302 • 420 days
|
|
Eye disorders
HEENT
|
0.33%
1/305 • Number of events 1 • 420 days
|
0.00%
0/302 • 420 days
|
|
Gastrointestinal disorders
Gastrointestinal
|
0.66%
2/305 • Number of events 2 • 420 days
|
0.66%
2/302 • Number of events 2 • 420 days
|
|
Gastrointestinal disorders
Hemorrhage Unrelated to Procedure
|
0.00%
0/305 • 420 days
|
0.33%
1/302 • Number of events 1 • 420 days
|
|
General disorders
EP/ ablation Other- Multi Organ Failure
|
0.33%
1/305 • Number of events 1 • 420 days
|
0.00%
0/302 • 420 days
|
|
General disorders
Pain Cardiovascular (Non-Ischemic)
|
0.00%
0/305 • 420 days
|
0.33%
1/302 • Number of events 1 • 420 days
|
|
General disorders
Hemorrhage Unelated to Procedure
|
0.00%
0/305 • 420 days
|
0.33%
1/302 • Number of events 1 • 420 days
|
|
General disorders
Pericarditis
|
0.33%
1/305 • Number of events 1 • 420 days
|
0.00%
0/302 • 420 days
|
|
Hepatobiliary disorders
Gastrointestinal
|
0.33%
1/305 • Number of events 1 • 420 days
|
0.33%
1/302 • Number of events 1 • 420 days
|
|
Infections and infestations
Cancer
|
0.33%
1/305 • Number of events 1 • 420 days
|
0.00%
0/302 • 420 days
|
|
Infections and infestations
Coronavirus Infection
|
0.00%
0/305 • 420 days
|
0.33%
1/302 • Number of events 1 • 420 days
|
|
Infections and infestations
Gastrointestinal
|
0.66%
2/305 • Number of events 2 • 420 days
|
0.33%
1/302 • Number of events 1 • 420 days
|
|
Infections and infestations
Localized Infection
|
0.00%
0/305 • 420 days
|
0.66%
2/302 • Number of events 2 • 420 days
|
|
Infections and infestations
Pneumonia
|
0.33%
1/305 • Number of events 1 • 420 days
|
0.00%
0/302 • 420 days
|
|
Infections and infestations
Systemic Infection
|
0.66%
2/305 • Number of events 2 • 420 days
|
0.33%
1/302 • Number of events 1 • 420 days
|
|
Injury, poisoning and procedural complications
Access Site Complication
|
0.33%
1/305 • Number of events 1 • 420 days
|
0.00%
0/302 • 420 days
|
|
Injury, poisoning and procedural complications
Gastrointestinal
|
0.33%
1/305 • Number of events 1 • 420 days
|
0.00%
0/302 • 420 days
|
|
Injury, poisoning and procedural complications
Musculoskeletal
|
0.33%
1/305 • Number of events 1 • 420 days
|
0.00%
0/302 • 420 days
|
|
Injury, poisoning and procedural complications
Oozing/Bleeding
|
0.66%
2/305 • Number of events 2 • 420 days
|
0.00%
0/302 • 420 days
|
|
Injury, poisoning and procedural complications
Physical Trauma
|
0.33%
1/305 • Number of events 1 • 420 days
|
0.66%
2/302 • Number of events 2 • 420 days
|
|
Injury, poisoning and procedural complications
Pseudoaneurysm
|
0.33%
1/305 • Number of events 1 • 420 days
|
0.66%
2/302 • Number of events 2 • 420 days
|
|
Investigations
Procedure Related Hypertension
|
0.33%
1/305 • Number of events 1 • 420 days
|
0.00%
0/302 • 420 days
|
|
Metabolism and nutrition disorders
Abnormal Lab Values
|
0.33%
1/305 • Number of events 1 • 420 days
|
0.00%
0/302 • 420 days
|
|
Metabolism and nutrition disorders
Pulmonary Edema
|
0.00%
0/305 • 420 days
|
0.33%
1/302 • Number of events 1 • 420 days
|
|
Metabolism and nutrition disorders
Whole Body Other
|
0.00%
0/305 • 420 days
|
0.33%
1/302 • Number of events 1 • 420 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
0.98%
3/305 • Number of events 3 • 420 days
|
0.66%
2/302 • Number of events 2 • 420 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal
|
0.33%
1/305 • Number of events 1 • 420 days
|
0.00%
0/302 • 420 days
|
|
Nervous system disorders
Cerebral Vascular Accident
|
0.00%
0/305 • 420 days
|
0.33%
1/302 • Number of events 1 • 420 days
|
|
Nervous system disorders
Neurological
|
0.00%
0/305 • 420 days
|
0.66%
2/302 • Number of events 2 • 420 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Syncope
|
0.00%
0/305 • 420 days
|
0.33%
1/302 • Number of events 1 • 420 days
|
|
Nervous system disorders
Transient Ischemic Attack
|
0.33%
1/305 • Number of events 1 • 420 days
|
0.33%
1/302 • Number of events 1 • 420 days
|
|
Psychiatric disorders
Psychological
|
0.00%
0/305 • 420 days
|
0.33%
1/302 • Number of events 1 • 420 days
|
|
Renal and urinary disorders
Procedure Related Genitourinary
|
0.33%
1/305 • Number of events 1 • 420 days
|
0.33%
1/302 • Number of events 1 • 420 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/305 • 420 days
|
0.33%
1/302 • Number of events 1 • 420 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.33%
1/305 • Number of events 1 • 420 days
|
0.00%
0/302 • 420 days
|
|
Skin and subcutaneous tissue disorders
Integumentary
|
0.00%
0/305 • 420 days
|
0.33%
1/302 • Number of events 1 • 420 days
|
|
Vascular disorders
Coronary Artery Disease
|
0.00%
0/305 • 420 days
|
0.33%
1/302 • Number of events 1 • 420 days
|
|
Vascular disorders
Death
|
0.00%
0/305 • 420 days
|
0.33%
1/302 • Number of events 1 • 420 days
|
|
Vascular disorders
Fistula (Arterial/Venous)
|
0.33%
1/305 • Number of events 1 • 420 days
|
0.00%
0/302 • 420 days
|
Other adverse events
| Measure |
FARAPULSE Pulsed Field Ablation System
n=305 participants at risk
FARAPULSE Pulsed Field Ablation System: Ablation using the FARAPULSE Pulsed Field Ablation System
|
Force Sensing Radiofrequency Ablation and Cryoballoon Ablation
n=302 participants at risk
Radiofrequency and Cryoballoon Ablation: Contact Force Enabled RF and Cryoballoon ablation catheters indicated for Paroxysmal Atrial Fibrillation
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
3.9%
12/305 • Number of events 15 • 420 days
|
7.3%
22/302 • Number of events 27 • 420 days
|
|
Gastrointestinal disorders
Gastrointestinal
|
3.9%
12/305 • Number of events 13 • 420 days
|
5.0%
15/302 • Number of events 18 • 420 days
|
|
Infections and infestations
Coronavirus infection
|
9.8%
30/305 • Number of events 30 • 420 days
|
12.3%
37/302 • Number of events 37 • 420 days
|
|
Injury, poisoning and procedural complications
Post Procedure Wound Discomfort
|
6.2%
19/305 • Number of events 19 • 420 days
|
2.6%
8/302 • Number of events 8 • 420 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
4.9%
15/305 • Number of events 16 • 420 days
|
7.0%
21/302 • Number of events 22 • 420 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place