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

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pulsed Field Ablation
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Pulsed Field Ablation, Paroxysmal, Ablation, Atrial fibrillation, ring-shaped ablation catheter

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tongji HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Three-dimensional Directed Pulsed Field Ablation

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Procedural success rate at 12 months after procedure
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
The occurrence of hospitalizations or emergency department visit due to symptoms of atrial arrhythmia at 6-month and 12-month follow-up
The occurrence of hospitalizations or emergency department visit due to symptoms of atrial arrhythmia at 6-month and 12-month of follow-up
Evaluation of pulsed electric field ablation instrument
operational stability; Hardware Connection validity; Software operability; degree of satisfaction
Evaluation of a disposable cardiac pulsed electric field ablation catheter
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

Full Information

First Posted
December 1, 2021
Last Updated
May 27, 2022
Sponsor
Tongji Hospital
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT05400928
Brief Title
The Effect and Safety of Pulsed Field Ablation (PFA) in Patients With Paroxysmal Atrial Fibrillation (PAF)
Acronym
ESPFA-CN21
Official Title
The Effect and Safety of Pulsed Field Ablation (PFA) in Patients With Paroxysmal Atrial Fibrillation (PAF)-A Prospective Multicenter Single-arm Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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)
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
Pulsed Field Ablation, Paroxysmal, Ablation, Atrial fibrillation, ring-shaped ablation catheter

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Three-dimensional Directed Pulsed Field Ablation
Arm Type
Experimental
Arm Description
Paroxysmal atrial fibrillation will be ablated with ring-shaped pulsed field ablation catheter directed by integrated three-dimensional mapping system
Intervention Type
Device
Intervention Name(s)
Pulsed Field Ablation
Intervention Description
pulmonary vein isolation will be performed with ring-shaped pulsed field ablation catheter directed by integrated three-dimensional mapping system
Primary Outcome Measure Information:
Title
Immediate success rate
Description
Procedural success for PAF is defined as the achievement of complete pulmonary venous electrical isolation
Time Frame
during procedure
Secondary Outcome Measure Information:
Title
Procedural success rate at 12 months after procedure
Description
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
Time Frame
between 3 months and 12 months after ablation
Title
The occurrence of hospitalizations or emergency department visit due to symptoms of atrial arrhythmia at 6-month and 12-month follow-up
Description
The occurrence of hospitalizations or emergency department visit due to symptoms of atrial arrhythmia at 6-month and 12-month of follow-up
Time Frame
at 6-month and 12-month
Title
Evaluation of pulsed electric field ablation instrument
Description
operational stability; Hardware Connection validity; Software operability; degree of satisfaction
Time Frame
baseline
Title
Evaluation of a disposable cardiac pulsed electric field ablation catheter
Description
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
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Paroxysmal Atrial Fibrillation (PAF) Exclusion Criteria: A history of atrial fibrillation ablation; Left ventricular ejectfraction(LVEF)<35% Left Atrium(LA)（echocardiography）>55mm Thrombus in the left atrial or heart before surgery New York Heart Association(NYHA) grade Ⅲ-Ⅳ second or third degree atrioventricular block Significant congenital heart defects (e.g. atrial septal defect or severe pulmonary vein stenosis, but except foramen ovale) Prosthetic valves Pacemakers or defibrillators (ICD) Hypertrophic cardiomyopathy, chronic obstructive pulmonary disease or myxoma Symptomatic carotid stenosis Untreated or uncontrolled hyperthyroidism or hypothyroidism Systemic active infection Renal failure with obvious bleeding tendency or undergoing hemodialysis Myocardial infarction or any cardiac intervention/open surgery within 3 months Stroke or transient ischemic attack within 6 months Obvious contraindication for interventional surgery who were determined by the investigator to be unable to undergo ablation Pregnant or lactating women or those who planned to have a family during the study period Have participated in clinical trials of other drugs or medical devices within 3 months Unsuitable to participate in this clinical trial by the investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daowen Wang, PhD
Phone
86-72-83662842
Email
dwwang@tjh.tjmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Wang, PhD
Phone
86-72-83663280
Email
newswangyan@tjh.tjmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daowen Wang, PhD
Organizational Affiliation
Tongji Hospital Wuhan, Hubei China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daowen Wang, PhD
Phone
86-27-83662842
Email
dwwang@tjh.tjmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yan Wang, PhD
Phone
86-27-83663280
Email
newswangyan@tjh.tjmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
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The Effect and Safety of Pulsed Field Ablation (PFA) in Patients With Paroxysmal Atrial Fibrillation (PAF)

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