Status:
COMPLETED
Safety-and-effectiveness Clinical Evaluation of Nanosecond-pulse Ablation for Atrial Fibrillation
Lead Sponsor:
Shenzhen Pulsecare Medical Technology Co., Ltd.
Conditions:
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This study is expected to include 166 subjects and Conducted at 11 research centers；The expected 12 month treatment success rate of using research instruments is 65%. Principle evaluation indexes： 1...
Eligibility Criteria
Inclusion
- Subjects must meet all of the following conditions to be enrolled:
- 18 to 80 years of age, gender is not limited
- Patients with a clinical diagnosis of paroxysmal atrial fibrillation confirmed by ECG
- Patients who were to undergo catheter ablation of atrial fibrillation
- Those who agreed to participate in this study and voluntarily signed the informed consent form
Exclusion
- Subjects were excluded if they met one of the following conditions:
- Patients who have had ablation for atrial fibrillation
- Patients with left ventricular ejection fraction (LVEF) \<35%.
- Patients with an anteroposterior diameter of the left atrium (echocardiography) \>50 mm
- Preoperative detection of a definite thrombus in the left atrium
- Patients with cardiac function class (NYHA) III-IV
- Patients with second-degree (type II) or third-degree atrioventricular block
- Patients with significant congenital heart defects (including atrial septal defect, ventricular septal defect, arterial ductus arteriosus, transposition ofthe grea, or severe pulmonicvalve, but not including foramen ovale persistens)
- Patients with implanted prosthetic valves or the presence of severe heart valve disease, who are not suitable for ablation for atrial fibrillation
- Patients with artificial cardiac pacemaker or implantable cardioverter defibrillator (ICDs)
- Patients diagnosed with hypertrophic obstructive cardiomyopathy, chronic obstructive pulmonary disease, or myxoma
- Patients who need to undergo left atrial appendage closure in the same surgery
- Patients found to have atrial flutter preoperatively and judged unsuitable by the investigators, or patients with atrial parasystolic tachycardia (non-pulmonary venous origin) or paroxysmal supraventricular tachycardia
- Patients with active systemic infection who are judged unsuitable for interventional therapy by the investigators
- Patients with systemic bleeding tendencies that preclude surgery or patients with renal failure undergoing hemodialysis
- Patients who have had a myocardial infarction or any interventional/open heart surgery (except coronary angiography) within 3 months
- Patients who have had a stroke (except asymptomatic stroke) or transient ischemic attack within 3 months
- Patients with significant contraindications to interventional procedures or with an expected survival of \<1 year who are judged by the investigator to be incapable of undergoing ablative procedures
- Females who are pregnant or breastfeeding or who are planning to have children during the study period
- Patients who have participated in a clinical trial of another drug or medical device within 3 months
- Patients who, in the opinion of the investigator, are not suitable for participation in this clinical trial
Key Trial Info
Start Date :
November 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2024
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT06039722
Start Date
November 3 2022
End Date
August 29 2024
Last Update
June 19 2025
Active Locations (1)
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1
the Second Affiliated Hospital of Sun Yat-sen University （Sun Yat-sen Memorial Hospital）
Guangzhou, Guangdong, China, 510120