A RWS of the FARAPULSE in A Chinese Population With PAF

A Real-world Study of the FARAPULSE Pulsed Field Ablation System in A Chinese Population With Paroxysmal Atrial Fibrillation

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.

Study Overview

• Status: Completed
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Device: FARAPULSE Pulsed Field Ablation System

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• China
  • Hainan
    • Bo'ao, Hainan, China, 571434
      • Boao Super Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation.

Description

Inclusion Criteria:

1. Subjects who are ≥ 18 and ≤ 75 years of age on the day of enrollment;
2. Subjects whose preoperative diagnosis is PAF confirmed by the clinician;
3. De novo ablation procedure for PAF with Class I or IIa recommendations* according to 2018 Chinese expert consensus on atrial fibrillation therapy;
4. 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;
5. Subjects who are willing and capable of providing informed consent.

Exclusion Criteria:

1. Subjects who, in the judgment of the investigator, have a life expectancy of less than one year before the procedure;
2. Women of childbearing potential who are, or plan to become, pregnant during the time of the study;
3. 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
4. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
FARAPULSE Pulsed Field Ablation System; Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation.	Device: FARAPULSE Pulsed Field Ablation System; Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation will be treated by FARAPULSE Pulsed Field Ablation System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	7 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Effectiveness Endpoints-1	Chronic Success: Proportion of subjects that free from effectiveness events defined as failure without AADs at 12 months post-procedure.	12 Months
Secondary Effectiveness Endpoints-2	Proportion of PVs that achieve electrical isolation by using the FARAPULSE Pulsed Field Ablation system only.	12 Months
Secondary Effectiveness Endpoints-3	Proportion of chronic success allowing antiarrhythmic drugs (AADs).	12 Months
Secondary Safety Endpoints	Proportion of subjects that free from primary safety events defined as above through 7 days after the procedure and free from the following serious procedure-related and/or device-related adverse events at any time through the completion of 12-month follow-up visit.	12 Months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Minglong Chen, Dr, Boao Super Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2023
• Primary Completion (Actual): August 21, 2023
• Study Completion (Actual): July 10, 2024

Study Registration Dates

• First Submitted: August 2, 2022
• First Submitted That Met QC Criteria: August 7, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 19, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: PF109

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No