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Arrhythmias, CardiacInsightPFANCT06014996

InsightPFA Trial of the LotosPFA Catheter

A study testing Pulsed Field Ablation (PFA) Therapy and Radiofrequency Ablation（RAF）Therapy in people with Arrhythmias, Cardiac and Paroxysmal Atrial Fibrillation, run by Insight Medtech Co., Ltd. at 10 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Pulsed Field Ablation (PFA) Therapy and Radiofrequency Ablation（RAF）Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
292 participants
Where
10 sitesChina
Study dates
4 Sep 2023to 3 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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..

Who cannot join

  • 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;
Show all 18Show fewer
  • 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;
  • Life expectancy of less than 12 months due to conditions such as advanced malignancy;
  • Women who are pregnant, breastfeeding, or planning to conceive during the trial period;
  • Any other situations deemed inappropriate for participation in the clinical trial as determined by the investigator

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

China10 sites

  • Beijing Anzhen Hospital

    Beijing, Beijing Municipality

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong

  • Sir Run Run Shaw Hospital

    Hanzhou, Zhejiang

  • Yan'an Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

  • The Affiliated People's Hospital of Ningbo University

    Ningbo, Zhejiang

  • Shanghai Zhongshan Hospital

    Shanghai, Shanghai Municipality

  • Weifang People's Hospital

    Weifang, Shandong

  • Xiamen Cardiovascular Hospital, Xiamen University

    Xiamen, Fujian

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Pulsed Field Ablation (PFA) Therapy, Radiofrequency Ablation（RAF）Therapy
Keywords
atrial fibrillation, catheter ablation, pulmonary vein isolation, pulsed field ablation, randomized controlled trial
Medical subject headings
Arrhythmias, Cardiac, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).

  • 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.

Study groups in NCT06014996
Study groupRoleWhat they receive
Test groupExperimentalTest group will utilize the cardiac PFA system (including a pulsed field generator, an expandable PFA catheter, and a steerable sheath) from Insight Medtech.
Receives: Device: Pulsed Field Ablation (PFA) Therapy
Control groupActive comparatorThe control group will utilize an RFA system (including CARTO VISITAG Module and the THERMOCOOL SMARTTOUCH Catheter) from Biosense Webster.
Receives: Device: Radiofrequency Ablation（RAF）Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: during the 12-month follow-up period after a 90-day blank period.

Secondary outcomes (14)

  1. Acute procedural success

    Acute procedural success is defined as the isolation of each PV after a 20 min observation period following the last ablation.

    Measured: after a 20 min observation period following the last ablation.

  2. Total procedure time

    Procedure duration in minute

    Measured: During the procedure

  3. Total left atrium indwelling time

    Procedure duration in minute

    Measured: During the procedure

  4. Total abaltion time

    Procedure duration in minute

    Measured: During the procedure

  5. Total X-ray exposure time

    Total time of X-ray exposure

    Measured: During the procedure

  6. Total X-ray exposure dose

    Total dose of X-ray exposure

    Measured: During the procedure

  7. Number of participants under general anesthesia

    Comparison of number of patients under general anesthesia between two groups.

    Measured: During the procedure

  8. Evaluation of the ablation system（questionnaire）

    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.

    Measured: immediately post ablation

  9. 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 :

    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

    Measured: immediately post ablation

  10. Evaluation of the adjustable introducer sheath set（questionnaire）

    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。

    Measured: immediately post ablation

  11. incidence of composite safety endpoint

    Composite safety endpoint composed of: procedure-related deaths, strokes, and transient ischemic attacks

    Measured: 12 months after the ablation

  12. 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

    Measured: 12 months after the ablation

  13. 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.

    Measured: 12 months after the ablation

  14. 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.

    Measured: 12 months after the ablation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2023
  2. Study start4 Sep 2023
  3. Primary completion9 Jun 2025
  4. Study completion3 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
symptomatic paroxysmal AF
Masking
None (open label)
Enrolment
292 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06014996
Sponsor's protocol ID
101000001M-CIP-001
Acronym
InsightPFA
Status last verified
Aug 2025
First submitted
7 Aug 2023
Last updated
17 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41338842

  • 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.

    PubMed 39853845

Questions about this trial

What is this clinical trial studying?

A study testing Pulsed Field Ablation (PFA) Therapy and Radiofrequency Ablation（RAF）Therapy in people with Arrhythmias, Cardiac and Paroxysmal Atrial Fibrillation, run by Insight Medtech Co., Ltd. at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the 12-month treatment success rate (time frame: during the 12-month follow-up period after a 90-day blank period.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06014996, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.

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