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

Launched by HANGZHOU DINOVA EP TECHNOLOGY CO., LTD · Nov 27, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring the use of a new treatment called the focal pulse ablation system for patients with certain heart rhythm problems known as typical atrial flutter and atrial fibrillation. The goal of the study is to determine how safe and effective this treatment is. They are currently looking for participants who are at least 18 years old and have experienced at least one episode of typical atrial flutter in the last six months. Importantly, participants should be able to understand the study's purpose and agree to take part.

If you decide to participate, you can expect to receive the focal pulse ablation treatment and will be monitored closely throughout the study to assess your health and any changes in your heart rhythm. However, there are some criteria that might exclude individuals from joining, such as having had certain heart procedures recently, severe heart disease, or specific medical conditions that could complicate the treatment. Overall, this study aims to provide valuable insights into a potential new option for managing these heart rhythm issues.

Gender

ALL

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.