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PFA for Paroxysmal Atrial Fibrillation

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pulsed electric field ablation device;Cardiac Pulsed Electric Field Ablation Catheter
Sponsored by
Shanghai Shangyang Medical Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring pulse field ablation, PFA, Paroxysmal Atrial Fibrillation, PAF

Eligibility Criteria

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

Inclusion Criteria: ≥18 and ≤75 years of age. Paroxysmal atrial fibrillation diagnosed by electrocardiogram or Holter ECG (including single-lead ECG recorder, lasting≥30s) within 1 year prior to enrollment. Clinical diagnosis of paroxysmal atrial fibrillation. Symptomatic patients who are ineffective or intolerant to at least one antiarrhythmic medication; or patients who are willing to undergo ablation despite not being on medication. Fully understand the treatment protocol and voluntarily sign the informed consent form and be willing to undergo the tests, procedures and follow-ups required by the protocol. Exclusion Criteria: Patients who have undergone left atrial surgery Left atrial thrombosis Patients of childbearing age who are unable to use effective contraception during the 12-month period after enrollment Anterior and posterior left atrial diameter ≥ 50 mm Left ventricular ejection fraction (LVEF) ≤ 40% Previous atrial septal repair or atrial mucinous tumor Active implants (e.g. pacemakers, ICDs, etc.) in the body NYHA class III-IV cardiac function [Appendix 1] Clear cerebrovascular disease within the last 6 months (including cerebral hemorrhage, stroke, transient ischemic attack) Cardiovascular events within the last 3 months (including acute myocardial infarction, coronary intervention or heart bypass surgery, prosthetic valve replacement or repair, atrial or ventriculotomy) Those with acute or severe systemic infections Patients with severe liver or kidney disease, malignant tumors or end-stage disease that, in the opinion of the investigator, may interfere with the treatment, evaluation and compliance of this trial Patients with significant bleeding tendency, hypercoagulable state and severe hematologic disorders Patients who have participated or are participating in other clinical trials within 3 months prior to enrollment Patients who have other conditions that the investigator considers inappropriate for participation in this trial.

Sites / Locations

  • General Hospital of Northern Theater Command, No. 83 Wenhua Road, Shenhe District, Shenyang, Liaoning Province

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single group target value method

Arm Description

This trial is a prospective, multicenter, single-group target value method study. All subjects are treated uniformly with the pulse ablation system provided in this protocol for paroxysmal AF, and the test results for the main indicators are statistically compared with the target values, a widely accepted standard in professional medicine, and the test results are considered to be attained if the one-sided 95% confidence interval for the test results is not lower than the target values.

Outcomes

Primary Outcome Measures

Rate of Treatment Success at 3-Month Post-Procedure
Refers to the postoperative phase (blank) after 3 months follow-up after process, without the use of class I and class III anti-arrhythmic drugs, by ECG, Holter, or Heart rate monitoring method based on equivalent (including a single lead electrocardiogram) confirmed that there are no last 30 s or af/the room/speed events account for the number of participants into the group of the proportion of the total number.
Rate of Treatment Success at 6-Month Post-Procedure
Refers to the postoperative phase (blank) after 6 months follow-up after process, without the use of class I and class III anti-arrhythmic drugs, by ECG, Holter, or Heart rate monitoring method based on equivalent (including a single lead electrocardiogram) confirmed that there are no last 30 s or af/the room/speed events account for the number of participants into the group of the proportion of the total number.
Rate of Treatment Success at 12-Month Post-Procedure
Refers to the postoperative phase (blank) after 12 months follow-up after process, without the use of class I and class III anti-arrhythmic drugs, by ECG, Holter, or Heart rate monitoring method based on equivalent (including a single lead electrocardiogram) confirmed that there are no last 30 s or af/the room/speed events account for the number of participants into the group of the proportion of the total number.

Secondary Outcome Measures

Immediate success rate: pulmonary vein isolation after ablation
Refers to the proportion of the number of subjects electrically isolated in each AF patient after surgery to the total number of subjects enrolled. Validation was a 20-minute wait after successful electrical isolation of the pulmonary vein, followed by reconfirmation of pulmonary vein block
Evaluation of Pulse Ablation Catheter
Evaluation of catheter operation performance;Catheter ablation parameters
Evaluation of Pulse Ablation equipment
System software operability;System operation stability;Hardware connection validity

Full Information

First Posted
November 6, 2022
Last Updated
June 13, 2023
Sponsor
Shanghai Shangyang Medical Technology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05618340
Brief Title
PFA for Paroxysmal Atrial Fibrillation
Official Title
A Study for the Effect and Safety of Cardiac Pulse Field Ablation System for Paroxysmal Atrial Fibrillation Guided by Columbus 3D EP Navigation System
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 26, 2022 (Actual)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Shangyang Medical Technology Co., Ltd.

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to verify the safety and efficacy of the cardiac pulse ablation system in paroxysmal atrial fibrillation to provide the basis for product registration and clinical application. The trial will be conducted at a clinical center with appropriate clinical cases, and paroxysmal atrial fibrillation ablation procedures will be performed by an authorized investigator using the trial product. The effectiveness and safety of the cardiac pulse ablation system in the treatment of paroxysmal atrial fibrillation will be verified by collecting the treatment success rate, immediate ablation success rate, procedure time and device use evaluation within 12 months after the procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
pulse field ablation, PFA, Paroxysmal Atrial Fibrillation, PAF

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This trial is a prospective, multicenter, single-group target value method study
Masking
None (Open Label)
Masking Description
Non-blind method
Allocation
N/A
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single group target value method
Arm Type
Experimental
Arm Description
This trial is a prospective, multicenter, single-group target value method study. All subjects are treated uniformly with the pulse ablation system provided in this protocol for paroxysmal AF, and the test results for the main indicators are statistically compared with the target values, a widely accepted standard in professional medicine, and the test results are considered to be attained if the one-sided 95% confidence interval for the test results is not lower than the target values.
Intervention Type
Device
Intervention Name(s)
Pulsed electric field ablation device;Cardiac Pulsed Electric Field Ablation Catheter
Intervention Description
Routinely placing a coronary sinus electrode catheter, puncturing the interatrial septum, placing one sheath into the left atrium, confirming that the catheter is well in place, and setting the treatment time of the pulse ablation system in advance. Pulmonary vein-by-pulmonary vein ablation using a circular pulse catheter, waiting for the end of the pulse ablation phase and immediate effect confirmation.
Primary Outcome Measure Information:
Title
Rate of Treatment Success at 3-Month Post-Procedure
Description
Refers to the postoperative phase (blank) after 3 months follow-up after process, without the use of class I and class III anti-arrhythmic drugs, by ECG, Holter, or Heart rate monitoring method based on equivalent (including a single lead electrocardiogram) confirmed that there are no last 30 s or af/the room/speed events account for the number of participants into the group of the proportion of the total number.
Time Frame
Refers to the postoperative phase (blank) after 3 months postoperatively
Title
Rate of Treatment Success at 6-Month Post-Procedure
Description
Refers to the postoperative phase (blank) after 6 months follow-up after process, without the use of class I and class III anti-arrhythmic drugs, by ECG, Holter, or Heart rate monitoring method based on equivalent (including a single lead electrocardiogram) confirmed that there are no last 30 s or af/the room/speed events account for the number of participants into the group of the proportion of the total number.
Time Frame
Refers to the postoperative phase (blank) after 6 months postoperatively
Title
Rate of Treatment Success at 12-Month Post-Procedure
Description
Refers to the postoperative phase (blank) after 12 months follow-up after process, without the use of class I and class III anti-arrhythmic drugs, by ECG, Holter, or Heart rate monitoring method based on equivalent (including a single lead electrocardiogram) confirmed that there are no last 30 s or af/the room/speed events account for the number of participants into the group of the proportion of the total number.
Time Frame
Refers to the postoperative phase (blank) after 12 months postoperatively
Secondary Outcome Measure Information:
Title
Immediate success rate: pulmonary vein isolation after ablation
Description
Refers to the proportion of the number of subjects electrically isolated in each AF patient after surgery to the total number of subjects enrolled. Validation was a 20-minute wait after successful electrical isolation of the pulmonary vein, followed by reconfirmation of pulmonary vein block
Time Frame
1 Day of surgery
Title
Evaluation of Pulse Ablation Catheter
Description
Evaluation of catheter operation performance;Catheter ablation parameters
Time Frame
1 Day of surgery
Title
Evaluation of Pulse Ablation equipment
Description
System software operability;System operation stability;Hardware connection validity
Time Frame
1 Day of surgery
Other Pre-specified Outcome Measures:
Title
The incidence of early onset (within 7 days of ablation) adverse events
Description
The primary safety endpoint
Time Frame
Within 7 days after the surgery
Title
Incidence of adverse events and serious adverse events associated with the study device
Description
Secondary Security Endpoints
Time Frame
Within 12 months after sign the informed consent form

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: ≥18 and ≤75 years of age. Paroxysmal atrial fibrillation diagnosed by electrocardiogram or Holter ECG (including single-lead ECG recorder, lasting≥30s) within 1 year prior to enrollment. Clinical diagnosis of paroxysmal atrial fibrillation. Symptomatic patients who are ineffective or intolerant to at least one antiarrhythmic medication; or patients who are willing to undergo ablation despite not being on medication. Fully understand the treatment protocol and voluntarily sign the informed consent form and be willing to undergo the tests, procedures and follow-ups required by the protocol. Exclusion Criteria: Patients who have undergone left atrial surgery Left atrial thrombosis Patients of childbearing age who are unable to use effective contraception during the 12-month period after enrollment Anterior and posterior left atrial diameter ≥ 50 mm Left ventricular ejection fraction (LVEF) ≤ 40% Previous atrial septal repair or atrial mucinous tumor Active implants (e.g. pacemakers, ICDs, etc.) in the body NYHA class III-IV cardiac function [Appendix 1] Clear cerebrovascular disease within the last 6 months (including cerebral hemorrhage, stroke, transient ischemic attack) Cardiovascular events within the last 3 months (including acute myocardial infarction, coronary intervention or heart bypass surgery, prosthetic valve replacement or repair, atrial or ventriculotomy) Those with acute or severe systemic infections Patients with severe liver or kidney disease, malignant tumors or end-stage disease that, in the opinion of the investigator, may interfere with the treatment, evaluation and compliance of this trial Patients with significant bleeding tendency, hypercoagulable state and severe hematologic disorders Patients who have participated or are participating in other clinical trials within 3 months prior to enrollment Patients who have other conditions that the investigator considers inappropriate for participation in this trial.
Facility Information:
Facility Name
General Hospital of Northern Theater Command, No. 83 Wenhua Road, Shenhe District, Shenyang, Liaoning Province
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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PFA for Paroxysmal Atrial Fibrillation

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