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

N/ANot Yet RecruitingNCT07162597

Shanghai Zhongshan Hospital200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Atrial Fibrillation (Paroxysmal)

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

PVI and SVCI

The proportion of subjects achieving successful PVI and SVCI using solely the FARAPULSE™ PFA system

Time frame: Periprocedural

Secondary Outcomes

Long-term procedural success rates

The percentage of subjects, among the total enrolled, who remained free of recurrence of atrial fibrillation, atrial flutter, or atrial tachycardia, with any episode lasting \>10 seconds on standard ECG or \>30 seconds on Holter monitoring.

Time frame: From the end of the 3-month blanking period post-ablation to the 12-month follow-up

Perioperative complications

Serious bradyarrhythmia requiring permanent pacemaker implantation, cardiac tamponade/cardiac perforation, thromboembolic events, severe coronary artery spasm (\>90% stenosis), phrenic nerve palsy, acute hemolysis and hemolysis-induced renal failure, vascular access complications requiring surgical or interventional management, atrioesophageal fistula, pulmonary vein stenosis, and death.

Time frame: From the end of the ablation to the 12-month follow-up