RecruitingNot ApplicableNCT06157437

An Exploratory Study of Focal Pulse Ablation System in the Treatment of Atrial Arrhythmia

Sponsor

Hangzhou Dinova EP Technology Co., Ltd

Enrollment

10 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation (AF)Typical Atrial Flutter

Summary

This is a prospective, single-group clinical study. The objective is to evaluate the safety and efficacy of focal pulse ablation system in the treatment of typical atrial flutter.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

Subjects aged at least 18;
Subjects with at least one typical atrial flutter attack recorded by ECG or holter in the 180 days prior to enrollment, and the ECG of other hospitals could be accepted;
Subjects are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to complete the follow-up according to the requirements of the program.

Exclusion Criteria19

Any prior cavo-tricuspid isthmus ablation;
Unstable angina;
Atrial flutter secondary to electrolyte disorder, thyroid disease or other reversible causes;
Myocardial infarction or coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within the prior three months;
At baseline, New York College of Cardiology (NYHA) heart function grades III and IV;
Implantable devices such as ICDs, CRTS and pacemakers in the body;
Atrial or ventricular tumors, blood clots, thrombus, or known clotting disorders were recorded within the prior 90 days;
Severe structural heart disease, including tricuspid stenosis, tricuspid malformation, or other congenital heart disease that prevents ablation surgery;
Previously received tricuspid metal valve replacement;
Thromboembolic events (including transient ischemic attacks) within the past 6 months;
Mural thrombosis, tumor, or other abnormality that interferes with vascular puncture or catheter operation;
Severe lung disease, pulmonary hypertension or any lung disease involving abnormal blood gas or severe breathing difficulties;
Anticoagulation contraindications and a history of blood clotting or abnormal bleeding;
Acute systemic infection;
Serum creatinine greater than twice the upper limit of normal, or any history of renal dialysis;
Women who are pregnant or breastfeeding or who cannot use contraception during the study period;
Enrollment in another clinical trial evaluating other devices or drugs during the same period;
Life expectancy less than 12 months (e.g. advanced malignancy);
Abnormalities or diseases considered by the investigator to be excluded from inclusion in this study.