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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06014996
Recruitment Status : Recruiting
First Posted : August 28, 2023
Last Update Posted : October 31, 2023
Sponsor:
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
Information provided by (Responsible Party):
Insight Lifetech Co., Ltd. ( Insight Medtech Co., Ltd. )

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.


Condition or disease Intervention/treatment Phase
Arrhythmias, Cardiac Paroxysmal Atrial Fibrillation Device: Pulsed Field Ablation (PFA) Therapy Device: Radiofrequency Ablation(RAF)Therapy Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 292 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: symptomatic paroxysmal AF
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized, and Controlled Study of Pulsed Field Ablation System
Actual Study Start Date : September 4, 2023
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. the 12-month treatment success rate [ Time Frame: from the blanking period to the end of 12-month follow-up ]
    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 :
  1. Immediate success rate [ Time Frame: 20 minutes after the ablation ]
    Immediate success rate refers to maintaining electrical isolation of the pulmonary vein 20 minutes after completion of all pulmonary vein ablation.

  2. Total procedure time [ Time Frame: During the procedure ]
    Procedure duration in minute

  3. Total left atrium indwelling time [ Time Frame: During the procedure ]
    Procedure duration in minute

  4. Total abaltion time [ Time Frame: During the procedure ]
    Procedure duration in minute

  5. Total X-ray exposure time [ Time Frame: During the procedure ]
    Total time of X-ray exposure

  6. Total X-ray exposure dose [ Time Frame: During the procedure ]
    Total dose of X-ray exposure

  7. Number of participants under general anesthesia [ Time Frame: During the procedure ]
    Comparison of number of patients under general anesthesia between two groups.

  8. Evaluation of the ablation system(questionnaire) [ Time Frame: immediately post ablation ]

    To evaluate the stability of both systems concluded from all enrolled case using questionnaire, including below measures :

    1. the stability of the ablation system ;
    2. the usability of the ablation system .

    For each system in 1., 2., and 3., only one of the following five ratings is given:

    1. very stable;
    2. stable, inspection was unaffected;
    3. slightly unstable, inspection was unaffected;
    4. N/A.

  9. Evaluation of the ablation catheter(questionnaire) [ Time Frame: immediately post ablation ]

    To evaluate the maneuvering performance of catheters in the two systems concluded from all enrolled case, including below measures :

    1. whether the ablation catheter can reach the expected position smoothly for ablation;
    2. whether the ablation catheter can be visible clearly under X-ray;
    3. whether the energy of the ablation catheter cannot be released after system operation

  10. Evaluation of the adjustable introducer sheath set(questionnaire) [ Time Frame: immediately post ablation ]

    To evaluate the adjustable introducer sheath set of the investigation device, including below measures :

    1. whether the introducer sheath can reach the expected position smoothly for ablation;
    2. whether the introducer sheath can be visible clearly under X-ray;
    3. whether the curved shape of the introducer sheath can be adjustable。

  11. incidence of composite safety endpoint [ Time Frame: 12 months after the ablation ]
    Composite safety endpoint composed of: death、stroke and transient ischemic attack

  12. incidence of surgical complications [ Time Frame: 12 months after the ablation ]
    surgical complications composed of: Vascular puncture/bleeding complications, cardiac tamponade and/or perforation, left atrium-esophageal fistula, phrenic nerve injury, pulmonary vein stenosis, etc.

  13. Incidence of severe adverse events [ Time Frame: 12 months after the ablation ]
    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.

  14. Incidence of device-related adverse events [ Time Frame: 12 months after the ablation ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06014996


Contacts
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Contact: Yumei Xue, PhD +86-13570082363 xymgdci@163.com
Contact: Weidong Lin, PhD +86-15914322775 linweidong@gdph.org.cn

Locations
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China, Beijing
Beijing Anzhen Hospital Not yet recruiting
Beijing, Beijing, China
Contact: Songnan Li, PhD    +86-13671346119    lisongnan@ccmu.edu.cn   
Contact: Lihong Huang, PhD    +86-15652491982    husthlh@163.com   
China, Fujian
Xiamen Cardiovascular Hospital, Xiamen University Not yet recruiting
Xiamen, Fujian, China
Contact: Dong Chang, PhD    +86-13779963201    cdheart@126.com   
China, Guangdong
Guangdong Provincial People's Hospital Recruiting
Guangzhou, Guangdong, China
Contact: Yumei Xue, PhD    +8613570082363    xymgdci@163.com   
Contact: Hongtao Liao, PhD       liaohongtong@163.com   
Nanfang Hospital, Southern Medical University Not yet recruiting
Guangzhou, Guangdong, China
Contact: Yuegang Wang, MD    +86-13725265686    wyg06@fimmu.com   
Contact: Senlin Huang, MD    +86-13268283120    1481561982@qq.com   
China, Liaoning
The First Affiliated Hospital of Dalian Medical University Not yet recruiting
Dalian, Liaoning, China
Contact: Xiaomeng Yin, MD    +86-13840885309      
China, Shandong
Weifang People's Hospital Not yet recruiting
Weifang, Shandong, China
Contact: Yanbo Chen    +86-15166460788      
Contact: Xuefu Hang         
China, Shanghai
Shanghai Zhongshan Hospital Not yet recruiting
Shanghai, Shanghai, China
Contact: Wenqing Zhu, PhD    +86-13701630800      
China, Yunnan
Yan'an Affiliated Hospital of Kunming Medical University Not yet recruiting
Kunming, Yunnan, China
Contact: Shaolong Li, Ph.D    +86-13700651472    13700651472@126.com   
Contact: Qiwei Liao, MD    +86-13678751296    13678751296@126.com   
China, Zhejiang
Sir Run Run Shaw Hospital Not yet recruiting
Hanzhou, Zhejiang, China
Contact: Chenyang Jiang, PhD    +86-13857190051      
The Affiliated People's Hospital of Ningbo University Not yet recruiting
Ningbo, Zhejiang, China
Contact: Huimin Chu, MD    +86-13566336742      
Sponsors and Collaborators
Insight Medtech Co., Ltd.
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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Responsible Party: Insight Medtech Co., Ltd.
ClinicalTrials.gov Identifier: NCT06014996    
Other Study ID Numbers: 101000001M-CIP-001
First Posted: August 28, 2023    Key Record Dates
Last Update Posted: October 31, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Insight Lifetech Co., Ltd. ( Insight Medtech Co., Ltd. ):
pulsed field ablation
Radiofrequency Ablation
Pulmonary Vein Isolation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes