CompletedNCT05493852Updated Jan 31, 2025Results posted

A RWS of the FARAPULSE in A Chinese Population With PAF

An observational study in Paroxysmal Atrial Fibrillation, sponsored by Boston Scientific Corporation. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-31.

Sponsored by Boston Scientific Corporation · Observational

Study type: Observational
Model: Other
Time perspective: Other
Enrollment: 30
Ages: 18 Years to 75 Years
Sex: All

Study summary

The real world study is a retrospective and/or prospective, single-center, single-arm observational study to observe the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System for treatment of recurrent, symptomatic Paroxysmal Atrial Fibrillation (PAF) in a Chinese population.

Read the detailed description

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.

The 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.

Primary endpoints analysis is planned to be conducted after all enrolled subjects have completed data collection at 1-month follow-up visit. All the subjects underwent study device treatment will be followed up to 12 months after the procedure, and the secondary and other endpoints will be analyzed then.

Conditions studied

Paroxysmal Atrial Fibrillation

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Atrial Fibrillation 3,872

In context

Atrial Fibrillation

3,872 studies on the registry are indexed under Atrial Fibrillation; 926 are open to participants now.

This study's enrollment of 30 is below the median of 300 across 1,364 observational studies indexed under Atrial Fibrillation.

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Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation.

Inclusion criteria

Subjects who are ≥ 18 and ≤ 75 years of age on the day of enrollment;
Subjects whose preoperative diagnosis is PAF confirmed by the clinician;
De novo ablation procedure for PAF with Class I or IIa recommendations* according to 2018 Chinese expert consensus on atrial fibrillation therapy;
Subjects who are able and willing to provide the defined observational data and/or participate in baseline and follow-up evaluations for the full study;
Subjects who are willing and capable of providing informed consent.

Exclusion criteria

Exclusion Criteria:

Subjects who, in the judgment of the investigator, have a life expectancy of less than one year before the procedure;
Women of childbearing potential who are, or plan to become, pregnant during the time of the study;
Subjects with any known contraindication to AF ablation with FARAPULSE Pulsed Field Ablation system, anticoagulation therapy, or contrast media in the judgment of the investigator or subjects unwillingness to use systemic anticoagulation
Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study.

Study design

Observational model: Other
Time perspective: Other
Enrollment: 30 participants (actual)
Patient registry: No

Groups and cohorts

FARAPULSE Pulsed Field Ablation System
Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation.
Device: FARAPULSE Pulsed Field Ablation System

Interventions

DeviceFARAPULSE Pulsed Field Ablation System
Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation will be treated by FARAPULSE Pulsed Field Ablation System.

What researchers measure

Primary outcomes

Number of Participants With Acute Procedural Success
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.
Time frame: Day 0
Number of Participants With SAE Related to the Procedure or Device at 7 Days Post Index Procedure
The 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.
Time frame: 7 Days

Results

Posted Dec 16, 2024

Participant flow

Participant flow — Overall Study
Milestone	FARAPULSE Pulsed Field Ablation System
Started	30
Completed	30
Not completed	0

Outcome measures

PrimaryNumber of Participants With Acute Procedural Success

Time frame:: Day 0
Reported as:: Count of participants · Participants

Number of Participants With Acute Procedural Success
Participants	FARAPULSE Pulsed Field Ablation System
Number of Participants With Acute Procedural Success	30

PrimaryNumber of Participants With SAE Related to the Procedure or Device at 7 Days Post Index Procedure

The 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.

Time frame:: 7 Days
Reported as:: Count of participants · Participants

Number of Participants With SAE Related to the Procedure or Device at 7 Days Post Index Procedure
Participants	FARAPULSE Pulsed Field Ablation System
Number of Participants With SAE Related to the Procedure or Device at 7 Days Post Index Procedure	0

Adverse events

Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
FARAPULSE Pulsed Field Ablation System	0/30 (0%)	4/30 (13.3%)	20/30 (66.7%)

Most frequent serious events

Most frequent serious events
Event	FARAPULSE Pulsed Field Ablation System
Atrial fibrillationCardiac disorders	3/30
PneumoniaInfections and infestations	1/30

Most frequent other events

Showing 10 of 32

Most frequent other events
Event	FARAPULSE Pulsed Field Ablation System
Myocardial injuryCardiac disorders	5/30
Supraventricular extrasystolesCardiac disorders	3/30
Atrial fibrillationCardiac disorders	2/30
Atrial flutterCardiac disorders	2/30
Puncture site haematomaGeneral disorders	2/30
AnaemiaBlood and lymphatic system disorders	2/30
Vascular pseudoaneurysmInjury, poisoning and procedural complications	2/30
Blood glucose increasedInvestigations	2/30
Angina pectorisCardiac disorders	1/30
Arteriospasm coronaryCardiac disorders	1/30

Baseline characteristics

Age, Continuous
Age, Continuous(years)	FARAPULSE Pulsed Field Ablation System
Mean	57.6 (32 to 73)

Sex: Female, Male
Sex: Female, Male(Participants)	FARAPULSE Pulsed Field Ablation System
Female	13
Male	17

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	FARAPULSE Pulsed Field Ablation System
American Indian or Alaska Native	0
Asian	30
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	0
More than one race	0
Unknown or Not Reported	0

Region of Enrollment
Region of Enrollment(participants)	FARAPULSE Pulsed Field Ablation System
China	30

Height
Height(cm)	FARAPULSE Pulsed Field Ablation System
Mean	165.4 (145 to 183)

BMI
BMI(kg/m^2)	FARAPULSE Pulsed Field Ablation System
Mean	25.3 (16.5 to 30.2)

Weight
Weight(Kg)	FARAPULSE Pulsed Field Ablation System
Mean	70 (34.6 to 100)

Study locations

1 site

Boao Super Hospital
Bo'ao, Hainan 571434, China

References and documents

Study documents

Study protocol · Jun 15, 2022
Statistical analysis plan · Feb 27, 2023

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05493852
Lead sponsor: Boston Scientific Corporation
Responsible party: Sponsor
First posted: Aug 9, 2022
Start date: Feb 24, 2023
Primary completion: Aug 21, 2023
Completion: Jul 10, 2024
Results posted: Dec 16, 2024
Last update: Jan 31, 2025

Study contacts

Minglong Chen, Dr

principal investigator · Boao Super Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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