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

A Prospective, Multicenter, Randomized, and Controlled Study of Pulsed Field Ablation System

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.

Study Overview

• Status: Recruiting
• Conditions: Arrhythmias, Cardiac; Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Device: Pulsed Field Ablation (PFA) Therapy; Device: Radiofrequency Ablation（RAF）Therapy

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).

• Study Type: Interventional
• Enrollment (Estimated): 292
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yumei Xue, PhD; Phone Number: +86-13570082363; Email: xymgdci@163.com
• Study Contact Backup: Name: Weidong Lin, PhD; Phone Number: +86-15914322775; Email: linweidong@gdph.org.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Not yet recruiting
      • Beijing Anzhen Hospital
      • Contact: Songnan Li, PhD; Phone Number: +86-13671346119; Email: lisongnan@ccmu.edu.cn
      • Contact: Lihong Huang, PhD; Phone Number: +86-15652491982; Email: husthlh@163.com
  • Fujian
    • Xiamen, Fujian, China
      • Not yet recruiting
      • Xiamen Cardiovascular Hospital, Xiamen University
      • Contact: Dong Chang, PhD; Phone Number: +86-13779963201; Email: cdheart@126.com
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Guangdong Provincial People's Hospital
      • Contact: Yumei Xue, PhD; Phone Number: +8613570082363; Email: xymgdci@163.com
      • Contact: Hongtao Liao, PhD; Email: liaohongtong@163.com
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • Nanfang Hospital, Southern Medical University
      • Contact: Yuegang Wang, MD; Phone Number: +86-13725265686; Email: wyg06@fimmu.com
      • Contact: Senlin Huang, MD; Phone Number: +86-13268283120; Email: 1481561982@qq.com
  • Liaoning
    • Dalian, Liaoning, China
      • Not yet recruiting
      • The First Affiliated Hospital of Dalian Medical University
      • Contact: Xiaomeng Yin, MD; Phone Number: +86-13840885309
  • Shandong
    • Weifang, Shandong, China
      • Not yet recruiting
      • Weifang People's Hospital
      • Contact: Yanbo Chen; Phone Number: +86-15166460788
      • Contact: Xuefu Hang
  • Shanghai
    • Shanghai, Shanghai, China
      • Not yet recruiting
      • Shanghai Zhongshan Hospital
      • Contact: Wenqing Zhu, PhD; Phone Number: +86-13701630800
  • Yunnan
    • Kunming, Yunnan, China
      • Not yet recruiting
      • Yan'an Affiliated Hospital of Kunming Medical University
      • Contact: Shaolong Li, Ph.D; Phone Number: +86-13700651472; Email: 13700651472@126.com
      • Contact: Qiwei Liao, MD; Phone Number: +86-13678751296; Email: 13678751296@126.com
  • Zhejiang
    • Hanzhou, Zhejiang, China
      • Not yet recruiting
      • Sir Run Run Shaw Hospital
      • Contact: Chenyang Jiang, PhD; Phone Number: +86-13857190051
    • Ningbo, Zhejiang, China
      • Not yet recruiting
      • The Affiliated People's Hospital of Ningbo University
      • Contact: Huimin Chu, MD; Phone Number: +86-13566336742

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18 years old ≤ age ≤ 75 years old, gender is not limited;
2. Patients with symptomatic paroxysmal atrial fibrillation confirmed by electrocardiogram or clinically diagnosed；
3. Catheter ablation of atrial fibrillation is planned;
4. 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:

1. Previous surgery or catheter ablation for atrial fibrillation;
2. The clinical diagnosis is persistent or long-term persistent atrial fibrillation;
3. Patients with left ventricular ejection fraction (LVEF) <40%, or patients with NYHA cardiac function class III and IV;
4. Left atrial diameter (echocardiography) ≥ 50mm;
5. Imaging examination results suggest left atrium or left atrial appendage thrombus;
6. There is a history of anticoagulation contraindications, abnormal blood coagulation or bleeding;
7. Patients with acute/active systemic infection;
8. Severe lung disease, pulmonary hypertension, or any lung disease involving severe dyspnea such as blood gas abnormalities;
9. Clinically diagnosed as hypertrophic cardiomyopathy, chronic obstructive pulmonary disease, known or suspected atrial myxoma;
10. 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;
11. Patients with cardioverter-defibrillators or other active implanted devices implanted in their bodies;
12. 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;
13. Received any carotid artery stent placement or endarterectomy within 6 months;
14. Patients who have obvious contraindications to interventional surgery and are judged by the investigator to be unable to undergo ablation surgery;
15. Participated in clinical trials of other drugs or devices during the same period;
16. Life expectancy is less than 12 months (such as advanced malignant tumor);
17. Women who are pregnant or breastfeeding or those who have family planning during the trial;
18. Other circumstances considered by the investigators to be inappropriate to participate in this clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pulsed Field Ablation; PVI using the PFA system (Insight Medtech).	Device: Pulsed Field Ablation (PFA) Therapy; Patients randomized to thePulsed Field Ablation group will undergo PVI using the PFA system (Insight Medtech).
Active Comparator: Radiofrequency Ablation; PVI using the RFA system ((Biosense Webster).	Device: Radiofrequency Ablation（RAF）Therapy; Patients randomized to Radiofrequency Ablation group will undergo PVI using the RFA system (Biosense Webster).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	from the blanking period to the end of 12-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months after the ablation
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.	12 months after the ablation
Immediate success rate	Immediate success rate refers to maintaining electrical isolation of the pulmonary vein 20 minutes after completion of all pulmonary vein ablation.	20 minutes after the ablation
Total procedure time	Procedure duration in minute	During the procedure
Total left atrium indwelling time	Procedure duration in minute	During the procedure
Total abaltion time	Procedure duration in minute	During the procedure
Total X-ray exposure time	Total time of X-ray exposure	During the procedure
Total X-ray exposure dose	Total dose of X-ray exposure	During the procedure
Number of participants under general anesthesia	Comparison of number of patients under general anesthesia between two groups.	During the procedure
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.	immediately post ablation
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	immediately post ablation
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。	immediately post ablation
incidence of composite safety endpoint	Composite safety endpoint composed of: death、stroke and transient ischemic attack	12 months after the ablation
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.	12 months after the ablation

Collaborators and Investigators

• Sponsor: Insight Medtech Co., Ltd.
• Collaborators: Shanghai Zhongshan Hospital; Guangdong Provincial People's Hospital; Beijing Anzhen Hospital; Sir Run Run Shaw Hospital; The First Affiliated Hospital of Dalian Medical University; The Affiliated People's Hospital of Ningbo University; Yan'an Affiliated Hospital of Kunming Medical University; Weifang People's Hospital; Xiamen Cardiovascular Hospital, Xiamen University; Insight Lifetech Co., Ltd.; Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 7, 2023
• First Submitted That Met QC Criteria: August 26, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Radiofrequency Ablation; Pulmonary Vein Isolation; pulsed field ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Atrial Fibrillation; Arrhythmias, Cardiac
• Other Study ID Numbers: 101000001M-CIP-001

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