The Effect and Safety of Pulsed Field Ablation (PFA) in Patients With Paroxysmal Atrial Fibrillation (PAF)

Last updated: May 27, 2022
Sponsor: Tongji Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dysrhythmia

Chest Pain

Arrhythmia

Treatment

N/A

Clinical Study ID

NCT05400928
JJETCT2021002
  • Ages 18-75
  • All Genders

Study Summary

This study is aimed to evaluate the Efficacy and Safety of Pulsed Field Ablation (PFA) in Patients with Paroxysmal Atrial Fibrillation (PAF)

Eligibility Criteria

Inclusion

Inclusion Criteria: Paroxysmal Atrial Fibrillation (PAF)

Exclusion

Exclusion Criteria:

  1. A history of atrial fibrillation ablation;
  2. Left ventricular ejectfraction(LVEF)<35%
  3. Left Atrium(LA)(echocardiography)>55mm
  4. Thrombus in the left atrial or heart before surgery
  5. New York Heart Association(NYHA) grade Ⅲ-Ⅳ
  6. second or third degree atrioventricular block
  7. Significant congenital heart defects (e.g. atrial septal defect or severe pulmonaryvein stenosis, but except foramen ovale)
  8. Prosthetic valves
  9. Pacemakers or defibrillators (ICD)
  10. Hypertrophic cardiomyopathy, chronic obstructive pulmonary disease or myxoma
  11. Symptomatic carotid stenosis
  12. Untreated or uncontrolled hyperthyroidism or hypothyroidism
  13. Systemic active infection
  14. Renal failure with obvious bleeding tendency or undergoing hemodialysis
  15. Myocardial infarction or any cardiac intervention/open surgery within 3 months
  16. Stroke or transient ischemic attack within 6 months
  17. Obvious contraindication for interventional surgery who were determined by theinvestigator to be unable to undergo ablation
  18. Pregnant or lactating women or those who planned to have a family during the studyperiod
  19. Have participated in clinical trials of other drugs or medical devices within 3 months
  20. Unsuitable to participate in this clinical trial by the investigator

Study Design

Total Participants: 144
Study Start date:
July 05, 2021
Estimated Completion Date:
December 31, 2023

Study Description

This clinical trial is a prospective, multi-center and single-arm Study. It will be carried out in 3 or more clinical trial institutions, and eligible patients with paroxysmal atrial fibrillation are enrolled. For those patients recruited, pulmonary vein isolation will be performed using pulsed field ablation device (Sichuan Jinjiang Electronic Technology Co., Ltd. Chengdu, China). The safety and efficacy of pulsed field ablation(PFA) in Patients with Paroxysmal Atrial Fibrillation (PAF) will be studied using ring-shaped pulsed field ablation catheter

Connect with a study center

  • Tongji Hospital

    Wuhan, Hubei 430030
    China

    Active - Recruiting

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