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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

292

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach

1 country

10 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.8 years study duration

First Submitted

Initial submission to the registry

August 7, 2023

Completed

21 days until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed

7 days until next milestone

Study Start

First participant enrolled

September 4, 2023

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2025

Completed

24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2025

Completed

Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

1.8 years

First QC Date

August 7, 2023

Last Update Submit

August 12, 2025

Conditions

Arrhythmias, Cardiac Paroxysmal Atrial Fibrillation

Keywords

atrial fibrillationcatheter ablationpulmonary vein isolationpulsed field ablationrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

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 Outcomes (14)

Acute procedural success
after a 20 min observation period following the last ablation.
Total procedure time
During the procedure
Total left atrium indwelling time
During the procedure
Total abaltion time
During the procedure
Total X-ray exposure time
During the procedure
+9 more secondary outcomes

Study Arms (2)

Test group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Pulsed Field Ablation (PFA) TherapyDEVICE

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).

Test group

Radiofrequency Ablation（RAF）TherapyDEVICE

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.

Control group

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

History of prior surgery or catheter ablation for atrial fibrillation (AF);
Clinical diagnosis of persistent or long-standing persistent AF;
Left ventricular ejection fraction (LVEF) \< 40% or New York Heart Association (NYHA) functional class III or IV;
Left atrial diameter (as measured by echocardiography) ≥ 50 mm;
Imaging findings suggestive of left atrial or left atrial appendage thrombus;
Contraindications to anticoagulation therapy, including a history of blood clotting disorders or abnormal bleeding;
Presence of acute or active systemic infection;
Significant lung disease, pulmonary hypertension, or any lung condition associated with severe dyspnea, such as abnormal blood gases;
Clinical diagnosis of hypertrophic cardiomyopatly, chronic obstructive pulmonary disease (COPD), or known/suspected atrial myxoma;
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;
Presence of an implanted cardioverter defibrillator or other active implanted devices;
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;
Any carotid stenting or endarterectomy performed within the past 6 months;
Patients who have clear contraindications to interventional procedures, rendering them unsuitable for the ablation procedure in the judgment of the investigator;
Participation in other drug or device clinical trials concurrently;
+3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Insight Medtech Co., Ltd.lead
Insight Lifetech Co., Ltd.collaborator
Guangdong Provincial People's Hospitalcollaborator
Beijing Anzhen Hospitalcollaborator
Sir Run Run Shaw Hospitalcollaborator
Shanghai Zhongshan Hospitalcollaborator
The Affiliated People's Hospital of Ningbo Universitycollaborator
The First Affiliated Hospital of Dalian Medical Universitycollaborator
Nanfang Hospital, Southern Medical Universitycollaborator
Xiamen Cardiovascular Hospital, Xiamen Universitycollaborator
Yan'an Affiliated Hospital of Kunming Medical Universitycollaborator
Weifang People's Hospitalcollaborator

Study Sites (10)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Location

Xiamen Cardiovascular Hospital, Xiamen University

Xiamen, Fujian, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Location

Weifang People's Hospital

Weifang, Shandong, China

Location

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Location

Yan'an Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Location

Sir Run Run Shaw Hospital

Hanzhou, Zhejiang, China

Location

The Affiliated People's Hospital of Ningbo University

Ningbo, Zhejiang, China

Location

Related Publications (2)

Lin W, Chu H, Wang C, Chang D, Yin X, Wang Y, Jiang C, Xu Y, Liao Q, Yang J, Zhu W, Li S, Gao W, Chen Y, Yu Y, Li Q, Liao H, Deng H, Wei W, Pu S, Guo Z, Xu D, Li W, Ouyang F, Xue Y; InsightPFA Investigators. Pulsed Field Ablation Using a Novel Biphasic Catheter vs Thermal Ablation for Paroxysmal Atrial Fibrillation: InsightPFA Trial. J Am Coll Cardiol. 2025 Dec 9;86(23):2314-2326. doi: 10.1016/j.jacc.2025.09.1593.
PMID: 41338842DERIVED
Lin W, Pu S, Chu H, Chang D, Yin X, Wang Y, Xu Y, Li S, Yang J, Zhu W, Li S, Gao W, Chen Y, Xu D, Jiang C, Xue Y. Rationale and Design of the InsightPFA Trial: A Prospective, Multicenter, Randomized Controlled Trial of the Irreversible Electroporation-Based Pulsed Field Ablation Versus Radiofrequency Ablation in Chinese Patients With Symptomatic Paroxysmal Atrial Fibrillation. J Cardiovasc Electrophysiol. 2025 Mar;36(3):632-641. doi: 10.1111/jce.16573. Epub 2025 Jan 24.
PMID: 39853845DERIVED

MeSH Terms

Conditions

Arrhythmias, CardiacAtrial Fibrillation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 7, 2023

First Posted

August 28, 2023

Study Start

September 4, 2023

Primary Completion

June 9, 2025

Study Completion

July 3, 2025

Last Updated

August 17, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing: Will not share

Locations

CN(10)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (14)

Study Arms (2)

Test group

Control group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (10)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Data Sharing

Locations