Trial Outcomes & Findings for A RWS of the FARAPULSE in A Chinese Population With PAF (NCT NCT05493852)
NCT ID: NCT05493852
Last Updated: 2025-01-31
Results Overview
The primary effectiveness endpoint is the acute procedural success, defined as the proportion of subjects that achieve electrical isolation of all PVs using FARAPULSE Pulsed Field Ablation system only.
Recruitment status
COMPLETED
Target enrollment
30 participants
Primary outcome timeframe
Day 0
Results posted on
2025-01-31
Participant Flow
Participant milestones
| Measure |
FARAPULSE Pulsed Field Ablation System
Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation.
FARAPULSE Pulsed Field Ablation System: Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation will be treated by FARAPULSE Pulsed Field Ablation System.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A RWS of the FARAPULSE in A Chinese Population With PAF
Baseline characteristics by cohort
| Measure |
FARAPULSE Pulsed Field Ablation System
n=30 Participants
Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation.
FARAPULSE Pulsed Field Ablation System: Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation will be treated by FARAPULSE Pulsed Field Ablation System.
|
|---|---|
|
Age, Continuous
|
57.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
30 participants
n=5 Participants
|
|
Height
|
165.4 cm
n=5 Participants
|
|
BMI
|
25.3 kg/m^2
n=5 Participants
|
|
Weight
|
70 Kg
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0The primary effectiveness endpoint is the acute procedural success, defined as the proportion of subjects that achieve electrical isolation of all PVs using FARAPULSE Pulsed Field Ablation system only.
Outcome measures
| Measure |
FARAPULSE Pulsed Field Ablation System
n=30 Participants
Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation.
FARAPULSE Pulsed Field Ablation System: Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation will be treated by FARAPULSE Pulsed Field Ablation System.
|
|---|---|
|
Number of Participants With Acute Procedural Success
|
30 Participants
|
PRIMARY outcome
Timeframe: 7 DaysThe primary safety endpoint is defined as the occurrence of the acute serious procedure-related and /or device-related adverse events at 7 days post index procedure.
Outcome measures
| Measure |
FARAPULSE Pulsed Field Ablation System
n=30 Participants
Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation.
FARAPULSE Pulsed Field Ablation System: Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation will be treated by FARAPULSE Pulsed Field Ablation System.
|
|---|---|
|
Number of Participants With SAE Related to the Procedure or Device at 7 Days Post Index Procedure
|
0 Participants
|
Adverse Events
FARAPULSE Pulsed Field Ablation System
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FARAPULSE Pulsed Field Ablation System
n=30 participants at risk
Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation.
FARAPULSE Pulsed Field Ablation System: Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation will be treated by FARAPULSE Pulsed Field Ablation System.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
10.0%
3/30 • Number of events 3 • 12 months
|
|
Infections and infestations
Pneumonia
|
3.3%
1/30 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
FARAPULSE Pulsed Field Ablation System
n=30 participants at risk
Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation.
FARAPULSE Pulsed Field Ablation System: Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation will be treated by FARAPULSE Pulsed Field Ablation System.
|
|---|---|
|
Cardiac disorders
Myocardial injury
|
16.7%
5/30 • Number of events 5 • 12 months
|
|
Cardiac disorders
Supraventricular extrasystoles
|
10.0%
3/30 • Number of events 3 • 12 months
|
|
Cardiac disorders
Atrial fibrillation
|
6.7%
2/30 • Number of events 2 • 12 months
|
|
Cardiac disorders
Atrial flutter
|
6.7%
2/30 • Number of events 2 • 12 months
|
|
Cardiac disorders
Angina pectoris
|
3.3%
1/30 • Number of events 1 • 12 months
|
|
Cardiac disorders
Arteriospasm coronary
|
3.3%
1/30 • Number of events 1 • 12 months
|
|
Cardiac disorders
Atrial tachycardia
|
3.3%
1/30 • Number of events 1 • 12 months
|
|
Cardiac disorders
Atrioventricular block second degree
|
3.3%
1/30 • Number of events 1 • 12 months
|
|
Cardiac disorders
Sinus arrest
|
3.3%
1/30 • Number of events 1 • 12 months
|
|
Cardiac disorders
Sinus bradycardia
|
3.3%
1/30 • Number of events 1 • 12 months
|
|
General disorders
Puncture site haematoma
|
6.7%
2/30 • Number of events 2 • 12 months
|
|
General disorders
Catheter site haematoma
|
3.3%
1/30 • Number of events 1 • 12 months
|
|
General disorders
Chest discomfort
|
3.3%
1/30 • Number of events 1 • 12 months
|
|
General disorders
Puncture site pain
|
3.3%
1/30 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
2/30 • Number of events 2 • 12 months
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
3.3%
1/30 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
3.3%
1/30 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
3.3%
1/30 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.3%
1/30 • Number of events 1 • 12 months
|
|
Infections and infestations
COVID-19
|
3.3%
1/30 • Number of events 1 • 12 months
|
|
Infections and infestations
Pneumonia
|
3.3%
1/30 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
6.7%
2/30 • Number of events 2 • 12 months
|
|
Investigations
Blood glucose increased
|
6.7%
2/30 • Number of events 2 • 12 months
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
3.3%
1/30 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
3.3%
1/30 • Number of events 1 • 12 months
|
|
Ear and labyrinth disorders
Ear discomfort
|
3.3%
1/30 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Constipation
|
3.3%
1/30 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
3.3%
1/30 • Number of events 1 • 12 months
|
|
Nervous system disorders
Headache
|
3.3%
1/30 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Anxiety disorder
|
3.3%
1/30 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Haematuria
|
3.3%
1/30 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
3.3%
1/30 • Number of events 1 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place