Clinical trial NCT06157437: An Exploratory Study of Focal Pulse Ablation System in the Treatment of Atrial Arrhythmia
Official title: An Exploratory Study of Focal Pulse Ablation System in the Treatment of Atrial Arrhythmia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Typical Atrial Flutter
Atrial Fibrillation (AF)
Lead sponsor: Hangzhou Dinova EP Technology Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-12-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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 outcomes:
measure: Acute procedural success
timeFrame: immediately after the procedure
Secondary outcomes:
measure: Chronic success
timeFrame: 6 months after procedure
measure: Ablation efficiency including total procedure time, catheter dwell time, pulse discharge time and total X-ray exposure time
timeFrame: immediately after the procedure
measure: Incidence of device-related major adverse events (MAE) within 7 days after ablation
timeFrame: within 7 days after ablation
measure: Incidence of device-related severe adverse events (SAE)
timeFrame: 3 months and 6 months after procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References: