Rationale and Design of the InsightPFA Trial

Not Applicable

Active, not recruiting

• Conditions: Arrhythmias, Cardiac; Paroxysmal Atrial Fibrillation
• Interventions: Device: Pulsed Field Ablation (PFA) Therapy; Device: Radiofrequency Ablation（RAF）Therapy

• Registration Number: NCT06014996
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2023-08-07
• Study First Submitted QC: 2023-08-26
• Study First Posted: 2023-08-28
• Study Start: 2023-09-04
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 292

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulsed Field Ablation	Pulsed Field Ablation (PFA) Therapy	PVI using the PFA system (Insight Medtech).
Radiofrequency Ablation	Radiofrequency Ablation（RAF）Therapy	PVI using the RFA system ((Biosense Webster).

Primary Outcome Measures

Name	Time	Method
the 12-month treatment success rate	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

Name	Time	Method
Immediate success rate	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.
Total procedure time	During the procedure	Procedure duration in minute
Total left atrium indwelling time	During the procedure	Procedure duration in minute
Total X-ray exposure dose	During the procedure	Total dose of X-ray exposure
Number of participants under general anesthesia	During the procedure	Comparison of number of patients under general anesthesia between two groups.
Evaluation of the ablation system（questionnaire）	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.
Total abaltion time	During the procedure	Procedure duration in minute
Total X-ray exposure time	During the procedure	Total time of X-ray exposure
incidence of composite safety endpoint	12 months after the ablation	Composite safety endpoint composed of: death、stroke and transient ischemic attack
Evaluation of the ablation catheter（questionnaire）	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
Evaluation of the adjustable introducer sheath set（questionnaire）	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。
incidence of surgical complications	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.
Incidence of severe adverse events	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.
Incidence of device-related adverse events	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.

Trial Locations

Locations (10)

The Affiliated People's Hospital of Ningbo University; 🇨🇳 Ningbo, Zhejiang, China

Beijing Anzhen Hospital; 🇨🇳 Beijing, Beijing, China

Xiamen Cardiovascular Hospital, Xiamen University; 🇨🇳 Xiamen, Fujian, China

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital of Dalian Medical University; 🇨🇳 Dalian, Liaoning, China

Weifang People's Hospital; 🇨🇳 Weifang, Shandong, China

Sir Run Run Shaw Hospital; 🇨🇳 Hanzhou, Zhejiang, China

Yan'an Affiliated Hospital of Kunming Medical University; 🇨🇳 Kunming, Yunnan, China

Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China