Rationale and Design of the InsightPFA Trial

Not Applicable

Active, not recruiting

• Conditions: Arrhythmias, Cardiac; Paroxysmal Atrial Fibrillation

• Registration Number: NCT06014996
• Lead Sponsor: Insight Medtech Co., Ltd.

Brief Summary

This trial aims to determine whether the InsightPFA for PVI is as effective and safe as standard RFA in the treatment of symptomatic paroxysmal AF.

Detailed Description

The InsightPFA trial is a prospective, multicenter, randomized controlled trial to compare the effectiveness and safety of PFA versus RFA for PVI in Chinese patients with symptomatic paroxysmal AF. Two hundred and ninety-two patients diagnosed with symptomatic paroxysmal AF will be randomly assigned to either the PFA group or the RFA group in a 1:1 ratio. All subjects will undergo PVI using PFA or AI guided RFA and be followed up to 12 months. The primary endpoint is defined as freedom from any episodes of AF/AFL/AT without Class I or III antiarrhythmic drugs during the 9-month follow-up period after a 90-day blank period. The secondary endpoints of effectiveness include acute treatment success and procedural data. The safety evaluation includes a composite of death, stroke and transient ischemic attack, procedure-related complications, device-related adverse events, and serious adverse events. A noninferiority comparison will be conducted between the novel PFA system and the existing RFA system in terms of both effectiveness and safety.

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: 2025-05-20
• Last Update Posted: 2025-05-23
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

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

Inclusion Criteria

1. Patients between the ages of 18 and 75 on the day of enrollment, without regard to gender.
2. Patients with symptomatic paroxysmal atrial fibrillation confirmed by an electrocardiogram or previously diagnosed.
3. Patients who are willing to undergo catheter ablation of atrial fibrillation.
4. Patients who agree to participate in this clinical trial voluntarily sign the informed consent form and be willing to complete the required examinations and follow-up as directed by the study protocol.

Exclusion Criteria

1. Previous surgery or catheter ablation for the treatment of atrial fibrillation

2. A clinical diagnosis of persistent or long-term persistent atrial fibrillation

3. Patients with LVEF < 40% or be classified as NYHA III or IV

4. Having an internal diameter of the left atrium > 50 mm (echocardiography)

5. Having thrombosis in the left atrium or left atrial appendage

6. Having a history of anticoagulation, blood clotting, or abnormal bleeding

7. Patients with acute or active systemic infections

8. Patients with severe lung diseases such as pulmonary arterial hypertension or any severe lung disease with abnormal blood gas saturation

9. Clinically diagnosed as hypertrophic cardiomyopathy, chronic obstructive pulmonary disease, or known or suspected atrial myxoma

10. Previous history of heart valve replacement or repair or artificial valve implantation; previous history of atrial septal defect occlusion or foramen ovale occlusion; or previous history of cardiac intervention or surgery

11. Patients with implanted ICDs or other active devices 12. Acute myocardial infarction, unstable angina, or any cardiac interventional or open surgery (other than coronary angiography) within 3 months; hospitalization for heart failure, stroke (other than asymptomatic stroke), or transient ischemic attack within 3 months 13. A history of any carotid artery stenting or endarterectomy procedures within 6 months

12. Patients with obvious contraindications to interventional procedures determined by the investigator 15. Participated in the clinical trials of other drugs or devices during the same period 16. With an expected life expectancy of less than 12 months (such as advanced cancer) 17. Women who are pregnant, breastfeeding, or intend to have children at the time of the trial 18. Other circumstances that the investigator deems unsuitable for participation in the clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the 12-month treatment success rate	during the 12-month follow-up period after a 90-day blank period.	12month treatment success, is defined as freedom from any episodes of AF/atrial flutter (AFL)/atrial tachycardia (AT) without the use of Class I or III antiarrhythmic drugs (AADs) during the 12-month follow-up period after a 90-day blank period. An electrocardiogram or 24 h Holter monitoring should be performed to confirm all episodes.; The occurrence of AF/AFL/AT during a blank period is not considered a treatment failure and can be treated with AADs (other than amiodarone), electric cardioversion, or only a time of catheter ablation procedure (the devices used during the redo procedure should be the same as those used in the original procedure). After the blanking period, any documentation of AF, AFL, or AT ≥ 30 s is considered a failure concerning the primary effectiveness endpoint. Following the blanking period, any use of a Class I or III AAD constitutes a treatment failure.

Secondary Outcome Measures

Name	Time	Method
Number of participants under general anesthesia	During the procedure	Comparison of number of patients under general anesthesia between two groups.
incidence of surgical complications	12 months after the ablation	surgical complications composed of: vascular puncture/bleeding complications, cardiac tamponades and/or perforations, left atrial-esophageal fistula, phrenic nerve injury, and pulmonary vein stenosis
Total left atrium indwelling time	During the procedure	Procedure duration in minute
Total abaltion time	During the procedure	Procedure duration in minute
Total X-ray exposure time	During the procedure	Total time of X-ray exposure
Total X-ray exposure dose	During the procedure	Total dose of X-ray exposure
Acute procedural success	after a 20 min observation period following the last ablation.	Acute procedural success is defined as the isolation of each PV after a 20 min observation period following the last ablation.
Total procedure time	During the procedure	Procedure duration in minute
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.
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 composite safety endpoint	12 months after the ablation	Composite safety endpoint composed of: procedure-related deaths, strokes, and transient ischemic attacks
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)

Beijing Anzhen Hospital; 🇨🇳 Beijing, Beijing, China

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

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

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

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

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

Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China

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

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

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