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ESPFA-CN21: The Effect and Safety of Pulsed Field Ablation (PFA) in Patients With Paroxysmal Atrial Fibrillation (PAF)

Sponsor
Tongji Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05400928
Collaborator
Jiangxi Provincial People's Hopital (Other), Second Affiliated Hospital of Guangzhou Medical University (Other), Central South University (Other), Second Affiliated Hospital of Nanchang University (Other), Zhongshan Hospital Xiamen University (Other), The First Affiliated Hospital of Dalian Medical University (Other), Fuwai Central China Cardiovascular Hospital (Other)
144
Enrollment
1
Location
1
Arm
29.9
Anticipated Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Pulsed Field Ablation
 N/A

Detailed 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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
144 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect and Safety of Pulsed Field Ablation (PFA) in Patients With Paroxysmal Atrial Fibrillation (PAF)-A Prospective Multicenter Single-arm Study
Actual Study Start Date :
Jul 5, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Three-dimensional Directed Pulsed Field Ablation

Paroxysmal atrial fibrillation will be ablated with ring-shaped pulsed field ablation catheter directed by integrated three-dimensional mapping system

Device: Pulsed Field Ablation
pulmonary vein isolation will be performed with ring-shaped pulsed field ablation catheter directed by integrated three-dimensional mapping system

Outcome Measures

Primary Outcome Measures

  1. Immediate success rate [during procedure]

    Procedural success for PAF is defined as the achievement of complete pulmonary venous electrical isolation

Secondary Outcome Measures

  1. Procedural success rate at 12 months after procedure [between 3 months and 12 months after ablation]

    Procedural success for PAF was defined as the absence of atrial fibrillation/atrial flutter/atrial tachycardia (duration ≥30s) without antiarrhythmic drugs between 3 months and 12 months after ablation

  2. The occurrence of hospitalizations or emergency department visit due to symptoms of atrial arrhythmia at 6-month and 12-month follow-up [at 6-month and 12-month]

    The occurrence of hospitalizations or emergency department visit due to symptoms of atrial arrhythmia at 6-month and 12-month of follow-up

  3. Evaluation of pulsed electric field ablation instrument [baseline]

    operational stability; Hardware Connection validity; Software operability; degree of satisfaction

  4. Evaluation of a disposable cardiac pulsed electric field ablation catheter [baseline]

    Whether the catheter can reach its desired location smoothly; X ray and shadow;development is clear; Whether the conduit bend is adjustable; Whether the electrophysiological signal is clear and stable; When used together with the mapping system, whether mapping and 3D modeling can be carried out; When used in conjunction with the mapping system, can the catheter be located; Is it possible to stimulate normally; Whether the ablation can be performed normally; Were there any blood clots after withdrawal; Is the tube body intact after withdrawal from the body; Surgeon satisfaction

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Paroxysmal Atrial Fibrillation (PAF)

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 pulmonary vein 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 the investigator to be unable to undergo ablation

  18. Pregnant or lactating women or those who planned to have a family during the study period

  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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tongji Hospital Wuhan Hubei China 430030

Sponsors and Collaborators

  • Tongji Hospital
  • Jiangxi Provincial People's Hopital
  • Second Affiliated Hospital of Guangzhou Medical University
  • Central South University
  • Second Affiliated Hospital of Nanchang University
  • Zhongshan Hospital Xiamen University
  • The First Affiliated Hospital of Dalian Medical University
  • Fuwai Central China Cardiovascular Hospital

Investigators

  • Principal Investigator: Daowen Wang, PhD, Tongji Hospital Wuhan, Hubei China

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dao Wen Wang, Professor, Tongji Hospital
ClinicalTrials.gov Identifier:
NCT05400928
Other Study ID Numbers:
  • JJETCT2021002
First Posted:
Jun 2, 2022
Last Update Posted:
Jun 2, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dao Wen Wang, Professor, Tongji Hospital
Pulsed Field Ablation
Paroxysmal
Ablation
Atrial fibrillation
ring-shaped ablation catheter
Additional relevant MeSH terms:
Atrial Fibrillation

Study Results

No Results Posted as of Jun 2, 2022