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

May 27, 2022 updated by: Dao Wen Wang, Tongji Hospital

The Effect and Safety of Pulsed Field Ablation (PFA) in Patients With Paroxysmal Atrial Fibrillation (PAF)-A Prospective Multicenter Single-arm Study

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immediate success rate
Time Frame: during procedure
Procedural success for PAF is defined as the achievement of complete pulmonary venous electrical isolation
during procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural success rate at 12 months after procedure
Time Frame: 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
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
Time Frame: 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
at 6-month and 12-month
Evaluation of pulsed electric field ablation instrument
Time Frame: baseline
operational stability; Hardware Connection validity; Software operability; degree of satisfaction
baseline
Evaluation of a disposable cardiac pulsed electric field ablation catheter
Time Frame: 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
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Collaborators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

December 1, 2021

First Submitted That Met QC Criteria

May 27, 2022

First Posted (Actual)

June 2, 2022

Study Record Updates

Last Update Posted (Actual)

June 2, 2022

Last Update Submitted That Met QC Criteria

May 27, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JJETCT2021002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Paroxysmal Atrial Fibrillation

Clinical Trials on Pulsed Field Ablation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe