A RWS of the FARAPULSE in A Chinese Population With PAF

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Device: FARAPULSE Pulsed Field Ablation System


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FARAPULSE Pulsed Field Ablation System<br>Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation. | Device: FARAPULSE Pulsed Field Ablation System<br>* Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation will be treated by FARAPULSE Pulsed Field Ablation System.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness Endpoint | 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 | 
| Primary Safety Endpoint | 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 |