Clinical trial NCT06014996: Rationale and Design of the InsightPFA Trial
Official title: A Prospective, Multicenter, Randomized Controlled Trial of the Irreversible Electroporation-based Pulsed Field Ablation Versus Radiofrequency Ablation for Symptomatic Paroxysmal Atrial Fibrillation.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Arrhythmias, Cardiac
Paroxysmal Atrial Fibrillation
Keywords: atrial fibrillation
catheter ablation
pulmonary vein isolation
pulsed field ablation
randomized controlled trial
Lead sponsor: Insight Lifetech Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Insight Lifetech Co., Ltd.
name: Guangdong Provincial People's Hospital
name: Beijing Anzhen Hospital
name: Sir Run Run Shaw Hospital
name: Shanghai Zhongshan Hospital
name: The Affiliated People's Hospital of Ningbo University
name: The First Affiliated Hospital of Dalian Medical University
name: Nanfang Hospital, Southern Medical University
name: Xiamen Cardiovascular Hospital, Xiamen University
name: Yan'an Affiliated Hospital of Kunming Medical University
name: Weifang People's Hospital
First posted: 2023-08-28
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: symptomatic paroxysmal AF
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

14. 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

Primary outcomes:
measure: the 12-month treatment success rate
timeFrame: during the 12-month follow-up period after a 90-day blank period.
Secondary outcomes:
measure: Acute procedural success
timeFrame: after a 20 min observation period following the last ablation.
measure: Total procedure time
timeFrame: During the procedure
measure: Total left atrium indwelling time
timeFrame: During the procedure
measure: Total abaltion time
timeFrame: During the procedure
measure: Total X-ray exposure time
timeFrame: During the procedure
measure: Total X-ray exposure dose
timeFrame: During the procedure
measure: Number of participants under general anesthesia
timeFrame: During the procedure
measure: Evaluation of the ablation system（questionnaire）
timeFrame: immediately post ablation
measure: Evaluation of the ablation catheter（questionnaire）
timeFrame: immediately post ablation
measure: Evaluation of the adjustable introducer sheath set（questionnaire）
timeFrame: immediately post ablation
measure: incidence of composite safety endpoint
timeFrame: 12 months after the ablation
measure: incidence of surgical complications
timeFrame: 12 months after the ablation
measure: Incidence of severe adverse events
timeFrame: 12 months after the ablation
measure: Incidence of device-related adverse events
timeFrame: 12 months after the ablation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
city: Xiamen
country: China
facility: Xiamen Cardiovascular Hospital, Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Weifang
country: China
facility: Weifang People's Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
state: Shanghai
city: Kunming
country: China
facility: Yan'an Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hanzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
city: Ningbo
country: China
facility: The Affiliated People's Hospital of Ningbo University
state: Zhejiang
Study officials:
References: