A RWS of the FARAPULSE in A Chinese Population With PAF

NCT05493852 | Completed Results

• 1 other identifier: PF109
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

FARAPULSE Pulsed Field Ablation System

Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation.

Device: FARAPULSE Pulsed Field Ablation System

Interventions

FARAPULSE Pulsed Field Ablation System DEVICE

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

FARAPULSE Pulsed Field Ablation System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Boao Super Hospital

Bo'ao, Hainan, 571434, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Xiuyue Jia
• Organization: Boston Scientific

xiuyue.jia@bsci.com

+86 15104673346

Study Officials

• Minglong Chen, Dr

  Boao Super Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 9, 2022
• Study Start: February 24, 2023
• Primary Completion: August 21, 2023
• Study Completion: July 10, 2024
• Last Updated: January 31, 2025
• Results First Posted: December 16, 2024

Record last verified: 2025-01

Locations

CN (1)