Focal Pulse field Ablation: Bidirectional block of the cavo-tricuspid isthmus (CTI) was performed with the novel focal pulse field ablation.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
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.
Primary outcome measure(s)
Acute procedural success — 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.
Trial sites (1)
Facility
City
Region
Status
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing
Beijing Municipality
Recruiting
More Hangzhou Dinova EP Technology Co., Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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