Status:
COMPLETED
InsightPFA Trial of the LotosPFA Catheter
Lead Sponsor:
Insight Medtech Co., Ltd.
Collaborating Sponsors:
Insight Lifetech Co., Ltd.
Guangdong Provincial People's Hospital
Conditions:
Arrhythmias, Cardiac
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
NA
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. Tw...
Eligibility Criteria
Inclusion
- 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..
Exclusion
- 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;
- 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
Key Trial Info
Start Date :
September 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 3 2025
Estimated Enrollment :
292 Patients enrolled
Trial Details
Trial ID
NCT06014996
Start Date
September 4 2023
End Date
July 3 2025
Last Update
August 17 2025
Active Locations (10)
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1
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
2
Xiamen Cardiovascular Hospital, Xiamen University
Xiamen, Fujian, China
3
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
4
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China