A RWS of the FARAPULSE in A Chinese Population With PAF

NCT ID: NCT05493852

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-24
• Study Completion Date: 2024-07-10

Brief 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.

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

Paroxysmal Atrial Fibrillation

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

FARAPULSE Pulsed Field Ablation System

Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation.

FARAPULSE Pulsed Field Ablation System

Intervention Type: DEVICE

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

Interventions

FARAPULSE Pulsed Field Ablation System

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Minglong Chen, Dr

Role: PRINCIPAL_INVESTIGATOR

Boao Super Hospital

Locations

Boao Super Hospital

Bo'ao, Hainan, China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PF109

Identifier Type: -

Identifier Source: org_study_id