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Comparison of PFA vs. RFA in Patients With Symptomatic Paroxysmal Atrial Fibrillation.

Primary Purpose

Arrhythmias, Cardiac, Paroxysmal Atrial Fibrillation

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pulsed Field Ablation (PFA) Therapy
Radiofrequency Ablation（RAF）Therapy
Sponsored by
Insight Medtech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arrhythmias, Cardiac focused on measuring pulsed field ablation, Radiofrequency Ablation, Pulmonary Vein Isolation

Eligibility Criteria

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

Inclusion Criteria: 18 years old ≤ age ≤ 75 years old, gender is not limited; Patients with symptomatic paroxysmal atrial fibrillation confirmed by electrocardiogram or clinically diagnosed； Catheter ablation of atrial fibrillation is planned; Agree to participate in this clinical trial, and voluntarily sign an informed consent form, and are willing to complete relevant inspections and follow-up visits in accordance with the requirements of the protocol. Exclusion Criteria: Previous surgery or catheter ablation for atrial fibrillation; The clinical diagnosis is persistent or long-term persistent atrial fibrillation; Patients with left ventricular ejection fraction (LVEF) <40%, or patients with NYHA cardiac function class III and IV; Left atrial diameter (echocardiography) ≥ 50mm; Imaging examination results suggest left atrium or left atrial appendage thrombus; There is a history of anticoagulation contraindications, abnormal blood coagulation or bleeding; Patients with acute/active systemic infection; Severe lung disease, pulmonary hypertension, or any lung disease involving severe dyspnea such as blood gas abnormalities; Clinically diagnosed as hypertrophic cardiomyopathy, chronic obstructive pulmonary disease, known or suspected atrial myxoma; Previous heart valve repair or replacement or artificial valve implantation; previous history of atrial septal defect closure, patent foramen ovale closure cardiac intervention or surgery; Patients with cardioverter-defibrillators or other active implanted devices implanted in their bodies; Myocardial infarction, unstable angina pectoris or any cardiac intervention/open surgery (except coronary angiography examination) occurred within 3 months; hospitalization due to heart failure, stroke (except asymptomatic stroke) within 3 months ) or transient ischemic attack; Received any carotid artery stent placement or endarterectomy within 6 months; Patients who have obvious contraindications to interventional surgery and are judged by the investigator to be unable to undergo ablation surgery; Participated in clinical trials of other drugs or devices during the same period; Life expectancy is less than 12 months (such as advanced malignant tumor); Women who are pregnant or breastfeeding or those who have family planning during the trial; Other circumstances considered by the investigators to be inappropriate to participate in this clinical trial.

Sites / Locations

  • Beijing Anzhen Hospital
  • Xiamen Cardiovascular Hospital, Xiamen University
  • Guangdong Provincial People's Hospital
  • Nanfang Hospital, Southern Medical University
  • The First Affiliated Hospital of Dalian Medical University
  • Weifang People's Hospital
  • Shanghai Zhongshan Hospital
  • Yan'an Affiliated Hospital of Kunming Medical University
  • Sir Run Run Shaw Hospital
  • The Affiliated People's Hospital of Ningbo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pulsed Field Ablation

Radiofrequency Ablation

Arm Description

PVI using the PFA system (Insight Medtech).

PVI using the RFA system ((Biosense Webster).

Outcomes

Primary Outcome Measures

the 12-month treatment success rate
12-month treatment success rate of abaltion, absence of atrial arrhythmia recurrence(AF/AFL/AT) on any type of recording (ECG or Holter),absence of use of class I or III AAD.

Secondary Outcome Measures

Immediate success rate
Immediate success rate refers to maintaining electrical isolation of the pulmonary vein 20 minutes after completion of all pulmonary vein ablation.
Total procedure time
Procedure duration in minute
Total left atrium indwelling time
Procedure duration in minute
Total abaltion time
Procedure duration in minute
Total X-ray exposure time
Total time of X-ray exposure
Total X-ray exposure dose
Total dose of X-ray exposure
Number of participants under general anesthesia
Comparison of number of patients under general anesthesia between two groups.
Evaluation of the ablation system（questionnaire）
To evaluate the stability of both systems concluded from all enrolled case using questionnaire, including below measures : the stability of the ablation system ; the usability of the ablation system . For each system in 1., 2., and 3., only one of the following five ratings is given: very stable; stable, inspection was unaffected; slightly unstable, inspection was unaffected; N/A.
Evaluation of the ablation catheter（questionnaire）
To evaluate the maneuvering performance of catheters in the two systems concluded from all enrolled case, including below measures : whether the ablation catheter can reach the expected position smoothly for ablation； whether the ablation catheter can be visible clearly under X-ray； whether the energy of the ablation catheter cannot be released after system operation
Evaluation of the adjustable introducer sheath set（questionnaire）
To evaluate the adjustable introducer sheath set of the investigation device， including below measures : whether the introducer sheath can reach the expected position smoothly for ablation； whether the introducer sheath can be visible clearly under X-ray； whether the curved shape of the introducer sheath can be adjustable。
incidence of composite safety endpoint
Composite safety endpoint composed of: death、stroke and transient ischemic attack
incidence of surgical complications
surgical complications composed of: Vascular puncture/bleeding complications, cardiac tamponade and/or perforation, left atrium-esophageal fistula, phrenic nerve injury, pulmonary vein stenosis, etc.
Incidence of severe adverse events
Refers to an event that occurs during the clinical trial that results in mortality or serious deterioration in patient health, including a fatal illness or injury, a permanent defect in body structure or body function, or an event that requires medical or surgical intervention to avoid one or more permanent defects in body structure or body function.
Incidence of device-related adverse events
Device-related adverse events refer to an adverse medical event related to the use of a device that occurs during the course of the clinical trial. However, a distinction should be made with respect to normal postoperative stress response, such as fever and chest and back discomfort, which, in the judgment of the investigator, need not be recorded as an adverse event. Recording of device-related adverse events will be applicable for conditions that are deemed by the investigator to be definitely related, possibly related, or of indeterminate relationship, to the test device.

Full Information

First Posted
August 7, 2023
Last Updated
August 26, 2023
Sponsor
Insight Medtech Co., Ltd.
Collaborators
Insight Lifetech Co., Ltd., Guangdong Provincial People's Hospital, Beijing Anzhen Hospital, Sir Run Run Shaw Hospital, Shanghai Zhongshan Hospital, The Affiliated People's Hospital of Ningbo University, The First Affiliated Hospital of Dalian Medical University, Nanfang Hospital, Southern Medical University, Xiamen Cardiovascular Hospital, Xiamen University, Yan'an Affiliated Hospital of Kunming Medical University, Weifang People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06014996
Brief Title
Comparison of PFA vs. RFA in Patients With Symptomatic Paroxysmal Atrial Fibrillation.
Official Title
A Prospective, Multicenter, Randomized, and Controlled Study of Pulsed Field Ablation System
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 20, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insight Medtech Co., Ltd.
Collaborators
Insight Lifetech Co., Ltd., Guangdong Provincial People's Hospital, Beijing Anzhen Hospital, Sir Run Run Shaw Hospital, Shanghai Zhongshan Hospital, The Affiliated People's Hospital of Ningbo University, The First Affiliated Hospital of Dalian Medical University, Nanfang Hospital, Southern Medical University, Xiamen Cardiovascular Hospital, Xiamen University, Yan'an Affiliated Hospital of Kunming Medical University, Weifang People's Hospital

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
This study is a mulitcentre, randomized, parallel-group evaluation of pulse field ablation(PFA) and radiofrequency ablation(RFA) in patients being treated for symptomatic paroxysmal AF. Pulmonary-vein isolation (PVI) is the primary intention of catheter ablation in both groups.
Detailed Description
Patients are randomized to either pulse field ablation(PFA) using the PFA catheters(Insight Medtech) or radiofrequency ablation(RFA) using the RFA catheters（Biosense Webster).During the ablation procedure, the (1:1) randomly selected ablation modality is used in the left atriuablation procedurem to electrically isolate the pulmonary veins (PVs).All investigators demonstrates the success of PVI by the abolition of conduction of atrial impulses into the PVs. Additional LA linear lesions or complex fractionated atrial electrogram ablation(s) are not allowed, and adenosine testing not performed, in either group. Concomitant ablation of previously documented avotricuspid isthmus-dependent atrial flutter (AFL) is allowed at the ablation procedure in both groups. The acute procedural end point is defined as the absence or dissociation of all PV potentials, as confirmed by bi-directional block using a circular mapping catheter after a 20 min waiting period (subsequent to the last ablation). Randomized groups are held throughout the trial, and re-ablation during the 3-month blanking period is allowed if the re-ablation is performing with the same type of catheter used at the ablation procedure. During the 3-month blanking period, antiarrhythmic drug (AAD) administration is allowed, but amiodarone iscontinuation is required at the time of the ablation procedure. Beta-adrenergic blockers is permitted and can be used at any time during this trail. The primary efficacy endpoint is the 12-month treatment success rate，defining as the use of no class I or III AAD and no AF/AFL/AT episodes between the time of ablation blank (within 3 months after the ablation procedure) and 12 months of follow-up. (Confirmed by a definite ECG or dynamic ECG).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmias, Cardiac, Paroxysmal Atrial Fibrillation
Keywords
pulsed field ablation, Radiofrequency Ablation, Pulmonary Vein Isolation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
symptomatic paroxysmal AF
Masking
None (Open Label)
Allocation
Randomized
Enrollment
292 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pulsed Field Ablation
Arm Type
Experimental
Arm Description
PVI using the PFA system (Insight Medtech).
Arm Title
Radiofrequency Ablation
Arm Type
Active Comparator
Arm Description
PVI using the RFA system ((Biosense Webster).
Intervention Type
Device
Intervention Name(s)
Pulsed Field Ablation (PFA) Therapy
Intervention Description
Patients randomized to thePulsed Field Ablation group will undergo PVI using the PFA system (Insight Medtech).
Intervention Type
Device
Intervention Name(s)
Radiofrequency Ablation（RAF）Therapy
Intervention Description
Patients randomized to Radiofrequency Ablation group will undergo PVI using the RFA system (Biosense Webster).
Primary Outcome Measure Information:
Title
the 12-month treatment success rate
Description
12-month treatment success rate of abaltion, absence of atrial arrhythmia recurrence(AF/AFL/AT) on any type of recording (ECG or Holter),absence of use of class I or III AAD.
Time Frame
from the blanking period to the end of 12-month follow-up
Secondary Outcome Measure Information:
Title
Immediate success rate
Description
Immediate success rate refers to maintaining electrical isolation of the pulmonary vein 20 minutes after completion of all pulmonary vein ablation.
Time Frame
20 minutes after the ablation
Title
Total procedure time
Description
Procedure duration in minute
Time Frame
During the procedure
Title
Total left atrium indwelling time
Description
Procedure duration in minute
Time Frame
During the procedure
Title
Total abaltion time
Description
Procedure duration in minute
Time Frame
During the procedure
Title
Total X-ray exposure time
Description
Total time of X-ray exposure
Time Frame
During the procedure
Title
Total X-ray exposure dose
Description
Total dose of X-ray exposure
Time Frame
During the procedure
Title
Number of participants under general anesthesia
Description
Comparison of number of patients under general anesthesia between two groups.
Time Frame
During the procedure
Title
Evaluation of the ablation system（questionnaire）
Description
To evaluate the stability of both systems concluded from all enrolled case using questionnaire, including below measures : the stability of the ablation system ; the usability of the ablation system . For each system in 1., 2., and 3., only one of the following five ratings is given: very stable; stable, inspection was unaffected; slightly unstable, inspection was unaffected; N/A.
Time Frame
immediately post ablation
Title
Evaluation of the ablation catheter（questionnaire）
Description
To evaluate the maneuvering performance of catheters in the two systems concluded from all enrolled case, including below measures : whether the ablation catheter can reach the expected position smoothly for ablation； whether the ablation catheter can be visible clearly under X-ray； whether the energy of the ablation catheter cannot be released after system operation
Time Frame
immediately post ablation
Title
Evaluation of the adjustable introducer sheath set（questionnaire）
Description
To evaluate the adjustable introducer sheath set of the investigation device， including below measures : whether the introducer sheath can reach the expected position smoothly for ablation； whether the introducer sheath can be visible clearly under X-ray； whether the curved shape of the introducer sheath can be adjustable。
Time Frame
immediately post ablation
Title
incidence of composite safety endpoint
Description
Composite safety endpoint composed of: death、stroke and transient ischemic attack
Time Frame
12 months after the ablation
Title
incidence of surgical complications
Description
surgical complications composed of: Vascular puncture/bleeding complications, cardiac tamponade and/or perforation, left atrium-esophageal fistula, phrenic nerve injury, pulmonary vein stenosis, etc.
Time Frame
12 months after the ablation
Title
Incidence of severe adverse events
Description
Refers to an event that occurs during the clinical trial that results in mortality or serious deterioration in patient health, including a fatal illness or injury, a permanent defect in body structure or body function, or an event that requires medical or surgical intervention to avoid one or more permanent defects in body structure or body function.
Time Frame
12 months after the ablation
Title
Incidence of device-related adverse events
Description
Device-related adverse events refer to an adverse medical event related to the use of a device that occurs during the course of the clinical trial. However, a distinction should be made with respect to normal postoperative stress response, such as fever and chest and back discomfort, which, in the judgment of the investigator, need not be recorded as an adverse event. Recording of device-related adverse events will be applicable for conditions that are deemed by the investigator to be definitely related, possibly related, or of indeterminate relationship, to the test device.
Time Frame
12 months after the ablation

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 years old ≤ age ≤ 75 years old, gender is not limited; Patients with symptomatic paroxysmal atrial fibrillation confirmed by electrocardiogram or clinically diagnosed； Catheter ablation of atrial fibrillation is planned; Agree to participate in this clinical trial, and voluntarily sign an informed consent form, and are willing to complete relevant inspections and follow-up visits in accordance with the requirements of the protocol. Exclusion Criteria: Previous surgery or catheter ablation for atrial fibrillation; The clinical diagnosis is persistent or long-term persistent atrial fibrillation; Patients with left ventricular ejection fraction (LVEF) <40%, or patients with NYHA cardiac function class III and IV; Left atrial diameter (echocardiography) ≥ 50mm; Imaging examination results suggest left atrium or left atrial appendage thrombus; There is a history of anticoagulation contraindications, abnormal blood coagulation or bleeding; Patients with acute/active systemic infection; Severe lung disease, pulmonary hypertension, or any lung disease involving severe dyspnea such as blood gas abnormalities; Clinically diagnosed as hypertrophic cardiomyopathy, chronic obstructive pulmonary disease, known or suspected atrial myxoma; Previous heart valve repair or replacement or artificial valve implantation; previous history of atrial septal defect closure, patent foramen ovale closure cardiac intervention or surgery; Patients with cardioverter-defibrillators or other active implanted devices implanted in their bodies; Myocardial infarction, unstable angina pectoris or any cardiac intervention/open surgery (except coronary angiography examination) occurred within 3 months; hospitalization due to heart failure, stroke (except asymptomatic stroke) within 3 months ) or transient ischemic attack; Received any carotid artery stent placement or endarterectomy within 6 months; Patients who have obvious contraindications to interventional surgery and are judged by the investigator to be unable to undergo ablation surgery; Participated in clinical trials of other drugs or devices during the same period; Life expectancy is less than 12 months (such as advanced malignant tumor); Women who are pregnant or breastfeeding or those who have family planning during the trial; Other circumstances considered by the investigators to be inappropriate to participate in this clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yumei Xue, PhD
Phone
+86-13570082363
Email
xymgdci@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Weidong Lin, PhD
Phone
+86-15914322775
Facility Information:
Facility Name
Beijing Anzhen Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Songnan Li, PhD
Phone
+86-13671346119
Email
lisongnan@ccmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Lihong Huang, PhD
Phone
+86-15652491982
Email
husthlh@163.com
Facility Name
Xiamen Cardiovascular Hospital, Xiamen University
City
Xiamen
State/Province
Fujian
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Chang, PhD
Phone
+86-13779963201
Email
cdheart@126.com
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yumei Xue, PhD
Phone
+8613570082363
Email
xymgdci@163.com
First Name & Middle Initial & Last Name & Degree
Hongtao Liao, PhD
Email
liaohongtong@163.com
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuegang Wang, MD
Phone
+86-13725265686
Email
wyg06@fimmu.com
First Name & Middle Initial & Last Name & Degree
Senlin Huang, MD
Phone
+86-13268283120
Email
1481561982@qq.com
Facility Name
The First Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaomeng Yin, MD
Phone
+86-13840885309
Facility Name
Weifang People's Hospital
City
Weifang
State/Province
Shandong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanbo Chen
Phone
+86-15166460788
First Name & Middle Initial & Last Name & Degree
Xuefu Hang
Facility Name
Shanghai Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenqing Zhu, PhD
Phone
+86-13701630800
Facility Name
Yan'an Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaolong Li, Ph.D
Phone
+86-13700651472
Email
13700651472@126.com
First Name & Middle Initial & Last Name & Degree
Qiwei Liao, MD
Phone
+86-13678751296
Email
13678751296@126.com
Facility Name
Sir Run Run Shaw Hospital
City
Hanzhou
State/Province
Zhejiang
Country
China
Facility Name
The Affiliated People's Hospital of Ningbo University
City
Ningbo
State/Province
Zhejiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huimin Chu, MD
Phone
+86-13566336742

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of PFA vs. RFA in Patients With Symptomatic Paroxysmal Atrial Fibrillation.

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