Status:
RECRUITING
An Exploratory Study of Focal Pulse Ablation System in the Treatment of Atrial Arrhythmia
Lead Sponsor:
Hangzhou Dinova EP Technology Co., Ltd
Conditions:
Typical Atrial Flutter
Atrial Fibrillation (AF)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06157437
Start Date
December 1 2023
End Date
June 30 2025
Last Update
February 11 2025
Active Locations (1)
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1
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China