InsightPFA Trial of the LotosPFA Catheter

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

292 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-04

Study Completion Date

2025-07-03

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Arrhythmias, Cardiac Paroxysmal Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

symptomatic paroxysmal AF

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Pulsed Field Ablation (PFA) Therapy

Intervention Type DEVICE

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).

Control group

The control group will utilize an RFA system (including CARTO VISITAG Module and the THERMOCOOL SMARTTOUCH Catheter) from Biosense Webster.

Group Type ACTIVE_COMPARATOR

Radiofrequency Ablation（RAF）Therapy

Intervention Type DEVICE

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.

Interventions

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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).

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No