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NCT Number: NCT07162597

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

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.

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Key information

Conditions

Atrial Fibrillation (Paroxysmal) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulsed Field Ablation

Device

Pulsed Field Ablation

Primary outcomes

  1. PVI and SVCI

    Time frame: Periprocedural

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

Secondary outcomes

  1. Long-term procedural success rates

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

    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.

  2. Perioperative complications

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

    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.

Other outcomes

  1. Total procedure time

    Time frame: Periprocedural

    The duration from femoral venous puncture until the removal of all devices from the body

  2. Anesthesia induction time

    Time frame: Periprocedural

    The duration from the administration of anesthetic agents until achieving a satisfactory anesthetic state (allowing initiation of the procedure)

  3. Left atrial operation time

    Time frame: Periprocedural

    The duration from the entry of the ablation catheter into the left atrium until its withdrawal from the left atrium

  4. Right atrial operation time

    Time frame: Periprocedural

    The duration from the withdrawal of the ablation catheter from the left atrium until its complete removal from the body

  5. Number of ablations

    Time frame: Periprocedural

    Total number of ablations, number of ablations for pulmonary vein isolation, and number of ablations for superior vena cava isolation.

Study contacts

Contact information is provided by the study sponsor or research team.

Chunfeng Dai, M.D.

CONTACT

[email protected]

86-021-64041990

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 9, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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