Rationale and Design of the InsightPFA Trial

Insight Medtech

Status: Active, not recruiting

Conditions: Paroxysmal Atrial Fibrillation; Arrhythmias, Cardiac

Treatments: Device: Pulsed Field Ablation (PFA) Therapy; Device: Radiofrequency Ablation（RAF）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. Patients between the ages of 18 and 75 on the day of enrollment, without regard to gender.
2. Patients with symptomatic paroxysmal atrial fibrillation confirmed by an electrocardiogram or previously diagnosed.
3. Patients who are willing to undergo catheter ablation of atrial fibrillation.
4. Patients who agree to participate in this clinical trial voluntarily sign the informed consent form and be willing to complete the required examinations and follow-up as directed by the study protocol.

Exclusion criteria

1. Previous surgery or catheter ablation for the treatment of atrial fibrillation

2. A clinical diagnosis of persistent or long-term persistent atrial fibrillation

3. Patients with LVEF < 40% or be classified as NYHA III or IV

4. Having an internal diameter of the left atrium > 50 mm (echocardiography)

5. Having thrombosis in the left atrium or left atrial appendage

6. Having a history of anticoagulation, blood clotting, or abnormal bleeding

7. Patients with acute or active systemic infections

8. Patients with severe lung diseases such as pulmonary arterial hypertension or any severe lung disease with abnormal blood gas saturation

9. Clinically diagnosed as hypertrophic cardiomyopathy, chronic obstructive pulmonary disease, or known or suspected atrial myxoma

10. Previous history of heart valve replacement or repair or artificial valve implantation; previous history of atrial septal defect occlusion or foramen ovale occlusion; or previous history of cardiac intervention or surgery

11. Patients with implanted ICDs or other active devices 12. Acute myocardial infarction, unstable angina, or any cardiac interventional or open surgery (other than coronary angiography) within 3 months; hospitalization for heart failure, stroke (other than asymptomatic stroke), or transient ischemic attack within 3 months 13. A history of any carotid artery stenting or endarterectomy procedures within 6 months

12. Patients with obvious contraindications to interventional procedures determined by the investigator 15. Participated in the clinical trials of other drugs or devices during the same period 16. With an expected life expectancy of less than 12 months (such as advanced cancer) 17. Women who are pregnant, breastfeeding, or intend to have children at the time of the trial 18. Other circumstances that the investigator deems unsuitable for participation in the clinical trial

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

PFA group

Experimental group

Description:

PFA 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

RFA group

Active Comparator group

Description:

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

Treatment:

Device: Radiofrequency Ablation（RAF）Therapy