InsightPFA Trial of the LotosPFA Catheter (InsightPFA)

Pulsed Field Ablation Using a Novel Biphasic Catheter vs Thermal Ablation for Paroxysmal Atrial Fibrilation:InsightPFA Trial

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 292
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Beijing Anzhen Hospital
  • Fujian
    • Xiamen, Fujian, China
      • Xiamen Cardiovascular Hospital, Xiamen University
  • Guangdong
    • Guangzhou, Guangdong, China
      • Nanfang Hospital, Southern Medical University
    • Guangzhou, Guangdong, China
      • Guangdong Provincial People's Hospital
  • Liaoning
    • Dalian, Liaoning, China
      • The First Affiliated Hospital of Dalian Medical University
  • Shandong
    • Weifang, Shandong, China
      • Weifang People's Hospital
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai Zhongshan Hospital
  • Yunnan
    • Kunming, Yunnan, China
      • Yan'an Affiliated Hospital of Kunming Medical University
  • Zhejiang
    • Hanzhou, Zhejiang, China
      • Sir Run Run Shaw Hospital
    • Ningbo, Zhejiang, China
      • The Affiliated People's Hospital of Ningbo University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age between 18 and 75 years, of either sex.
2. Patients with ECG-confirmed or clinically definite diagnosis of symptomatic paroxysmal atrial fibrillation (PAF).
3. Scheduled to undergo catheter ablation for atrial fibrillation
4. Willing to participate in this clinical trial, voluntarily sign the informed consent form, and commit to completing required examinations and follow-ups per protocol..

Exclusion Criteria:

1. History of prior surgery or catheter ablation for atrial fibrillation (AF);
2. Clinical diagnosis of persistent or long-standing persistent AF;
3. Left ventricular ejection fraction (LVEF) < 40% or New York Heart Association (NYHA) functional class III or IV;
4. Left atrial diameter (as measured by echocardiography) ≥ 50 mm;
5. Imaging findings suggestive of left atrial or left atrial appendage thrombus;
6. Contraindications to anticoagulation therapy, including a history of blood clotting disorders or abnormal bleeding;
7. Presence of acute or active systemic infection;
8. Significant lung disease, pulmonary hypertension, or any lung condition associated with severe dyspnea, such as abnormal blood gases;
9. Clinical diagnosis of hypertrophic cardiomyopatly, chronic obstructive pulmonary disease (COPD), or known/suspected atrial myxoma;
10. History of previous heart valve repair or replacement, implantation of a prosthetic valve, or previous cardiac interventions such as atrial septal defect closure or patent foramen ovale closure;
11. Presence of an implanted cardioverter defibrillator or other active implanted devices;
12. Myocardial infarction, unstable angina, or any cardiac intervention/open surgery (excluding coronary angiography) within the past 3 months; hospitalization for heart failure, stroke (excluding silent stroke), or transient ischemic attack within the past 3 months;
13. Any carotid stenting or endarterectomy performed within the past 6 months;
14. Patients who have clear contraindications to interventional procedures, rendering them unsuitable for the ablation procedure in the judgment of the investigator;
15. Participation in other drug or device clinical trials concurrently;
16. Life expectancy of less than 12 months due to conditions such as advanced malignancy;
17. Women who are pregnant, breastfeeding, or planning to conceive during the trial period;
18. Any other situations deemed inappropriate for participation in the clinical trial as determined by the investigator

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: Test group; Test group will utilize the cardiac PFA system (including a pulsed field generator, an expandable PFA catheter, and a steerable sheath) from Insight Medtech.	Device: Pulsed Field Ablation (PFA) Therapy; In the test group, subjects will undertake PVI using the PFA system including a nanosecond-scale pulsed field generator (InRythm, Insight Lifetech, Shenzhen, China), a lotos catheter that is expandable over the wire (LotosPFA, Insight Lifetech), and a customized 12-French steerable sheath (InBridge, Insight Lifetech).
Active Comparator: Control group; The control group will utilize an RFA system (including CARTO VISITAG Module and the THERMOCOOL SMARTTOUCH Catheter) from Biosense Webster.	Device: Radiofrequency Ablation（RAF）Therapy; In the control group, subjects will undergo PVI using an RFA system including CARTO VISITAG Module and the THERMOCOOL SMARTTOUCH Catheter (Biosense Webster Inc., Diamond Bar, CA, USA). PVI was performed with AI values of 400-450 in the anterior, 300-350 at the posterior wall of the LA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the 12-month treatment success rate	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.	during the 12-month follow-up period after a 90-day blank period.

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
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
Acute procedural success	Acute procedural success is defined as the isolation of each PV after a 20 min observation period following the last ablation.	after a 20 min observation period following the last ablation.
incidence of composite safety endpoint	Composite safety endpoint composed of: procedure-related deaths, strokes, and transient ischemic attacks	12 months after the ablation
incidence of surgical complications	surgical complications composed of: vascular puncture/bleeding complications, cardiac tamponades and/or perforations, left atrial-esophageal fistula, phrenic nerve injury, and pulmonary vein stenosis	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 (Actual): June 9, 2025
• Study Completion (Actual): July 3, 2025

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): August 17, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: randomized controlled trial; atrial fibrillation; catheter ablation; pulmonary vein isolation; pulsed field ablation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart 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
• product manufactured in and exported from the U.S.: No