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

NCT07162597 | Not Yet Recruiting

• 1 other identifier: B2025-426R
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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)

Outcome Measures

Primary Outcomes (1)

• PVI and SVCI

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

  Periprocedural

Secondary Outcomes (2)

• Long-term procedural success rates

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

• Perioperative complications

  From the end of the ablation to the 12-month follow-up

Other Outcomes (5)

• Total procedure time

  Periprocedural

• Anesthesia induction time

  Periprocedural

• Left atrial operation time

  Periprocedural

Study Arms (1)

Pulsed Field Ablation

EXPERIMENTAL

Using the FARAPULSE™ System

Device: Pulsed Field Ablation

Interventions

Pulsed Field Ablation DEVICE

Pulsed Field Ablation

Pulsed Field Ablation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Boston Scientific Corporation: collaborator

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Chunfeng Dai, M.D.

CONTACT

86-021-64041990; dai.chunfeng@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2025
• First Posted: September 9, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share