InsightPFA Trial of the LotosPFA Catheter

Insight Medtech

Status: Completed

Conditions: Paroxysmal Atrial Fibrillation; Arrhythmias, Cardiac

Treatments: Device: Radiofrequency Ablation（RAF）Therapy; Device: Pulsed Field Ablation (PFA) Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06014996

101000001M-CIP-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 292 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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292 participants in 2 patient groups

Test group

Experimental group

Description:

Test group will utilize the cardiac PFA system (including a pulsed field generator, an expandable PFA catheter, and a steerable sheath) from Insight Medtech.

Treatment:

Device: Pulsed Field Ablation (PFA) Therapy

Control group

Active Comparator group

Description:

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

Treatment:

Device: Radiofrequency Ablation（RAF）Therapy