A Study Evaluating the Effectiveness and Safety of Pulsed Field Ablation Using the FARAPULSE™ System for Electrical Isolation of Pulmonary Veins and Superior Vena Cava

NCT ID: NCT07162597

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2028-06-30

Brief Summary

This study is a prospective, single-center, single-arm clinical trial planning to screen and enroll 200 subjects. It aims to evaluate the efficacy and safety of pulsed field ablation (PFA) using the FARAPULSE™ system for pulmonary vein isolation (PVI) and superior vena cava isolation (SVCI) in Chinese patients with paroxysmal atrial fibrillation (PAF). Baseline preoperative data, along with intraoperative and postoperative follow-up information, will be collected. The primary endpoint is the proportion of subjects achieving successful PVI and SVCI using solely the FARAPULSE™ PFA system. Secondary endpoints include long-term procedural success rates and various procedural parameters. Additionally, the incidence of adverse events will be recorded as safety endpoints. The study adopts a single-arm target value design hypothesis, and research data will also be compared with historical data from patients treated with radiofrequency ablation for PVI and SVCI to further evaluate the efficacy of PFA. Subgroup analysis will be conducted in patients with heart failure to assess the efficacy and safety of PFA in this population.

Conditions

Atrial Fibrillation (Paroxysmal)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pulsed Field Ablation

Using the FARAPULSE™ System

Group Type: EXPERIMENTAL

Pulsed Field Ablation

Intervention Type: DEVICE

Pulsed Field Ablation

Interventions

Pulsed Field Ablation

Pulsed Field Ablation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 75 years.
• Documented diagnosis of paroxysmal atrial fibrillation (PAF), defined as typical AF electrographic characteristics (absence of P waves with irregular fibrillatory waves) recorded on 12-lead ECG or symptomatic Holter monitoring, with each episode lasting less than 7 days.
• Symptomatic despite attempted antiarrhythmic drug therapy.
• Scheduled to undergo initial catheter ablation procedure.
• Voluntarily provided written informed consent.

Exclusion Criteria

• AF secondary to electrolyte imbalance, thyroid disorders, or other reversible/non-cardiac causes.
• Persistent atrial fibrillation.
• Presence of persistent left superior vena cava.
• Contraindications to pulsed field ablation (e.g., left atrial appendage thrombus, post-atrial septal defect device closure, permanent metallic implants in the left atrium) or contraindications to anticoagulant therapy.
• Unsuitable for deep sedation/anesthesia per operator assessment.
• Life expectancy less than 1 year.
• Other conditions deemed inappropriate for inclusion by the investigator.

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

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Chunfeng Dai, M.D.

Role: CONTACT

dai.chunfeng@zs-hospital.sh.cn

86-021-64041990

Other Identifiers

B2025-426R

Identifier Type: -

Identifier Source: org_study_id