Recruiting

Real World Data of FARAPULSE™ Ablation in Chinese Population

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Arrhythmias, Cardiac+3

+ Atrial Fibrillation

+ Cardiovascular Diseases

Over 18 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other

Utilizing specific methods not covered by standard models in order to address unique research questions.
Observational
Study Start: October 2025
See protocol details

Summary

Principal SponsorBoston Scientific Corporation
Study ContactHui Lin
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 23, 2025

Actual date on which the first participant was enrolled.

This study focuses on the Chinese population undergoing treatment with the FARAPULSE™ Pulsed Field Ablation System. It's an observational study, meaning it follows and examines the effects of this treatment in real-world settings, without any random assignment or control group. The study is important as it helps understand the long-term safety and effectiveness of the FARAPULSE™ PFA system in a real-world context, potentially improving care for those undergoing this procedure. All participants who sign the informed consent form will be included in the study and followed for three years. After enrollment, participants will undergo the standard procedure with the FARAPULSE™ PFA system. Follow-ups will occur at pre-discharge, 3 months, 6 months (over a phone call), 12 months (mandatory in-clinic visit), 24 months, and 36 months. The study will monitor device- or procedure-related serious adverse events, the failure-free rate at 12 months post-procedure, and all procedure- and device-related adverse events at 12 months, 2 years, and 3 years.

Official TitleReal World Data Collection in Chinese Population Treated With the FARAPULSE™ Pulsed Field Ablation System
Principal SponsorBoston Scientific Corporation
Study ContactHui Lin
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

500 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other

Some studies use unique or mixed approaches that don't fit standard categories. These may include innovative observational methods or studies tailored to specific research questions.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Conditions

Pathology

Arrhythmias, CardiacAtrial FibrillationCardiovascular DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

2 inclusion criteria required to participate
Subjects whose age is 18 years or above

Subjects intended to be treated with the FARAPULSETM Pulsed Field Ablation system for cardiac tissue ablation, per physician's medical judgement, and as per hospitals' standard of care

2 exclusion criteria prevent from participating
Subjects with a life expectancy of <= 1 year per investigator's opinion

Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor to determine eligibility

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, ChinaOpen Fuwai Hospital, Chinese Academy of Medical Sciences in Google Maps
Recruiting
One Study Center