NCT06157437RecruitingNot Applicable
An Exploratory Study of Focal Pulse Ablation System in the Treatment of Atrial Arrhythmia
Hangzhou Dinova EP Technology Co., Ltd1 site in 1 country10 target enrollmentStarted: December 1, 2023Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Acute procedural success
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Acute procedural success
Time Frame: immediately after the procedure
Acute procedural success is defined as the creation of bidirectional conduction block across the cavo-tricuspid isthmus immediately and 30 minutes after ablation.
Secondary Outcomes
- Ablation efficiency including total procedure time, catheter dwell time, pulse discharge time and total X-ray exposure time(immediately after the procedure)
- Incidence of device-related severe adverse events (SAE)(3 months and 6 months after procedure)
- Chronic success(6 months after procedure)
- Incidence of device-related major adverse events (MAE) within 7 days after ablation(within 7 days after ablation)
Investigators
Study Sites (1)
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