Using focal pulse ablation to treat atrial flutter and fibrillation

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

This study is testing a new treatment using focal pulse ablation to see if it can help people with atrial flutter feel better and reduce their symptoms.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hangzhou Dinova EP Technology Co., Ltd (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06157437 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the safety and efficacy of a focal pulse ablation system specifically for patients suffering from typical atrial flutter. It is a prospective, single-group study that includes participants who have experienced at least one episode of atrial flutter within the last 180 days. The study aims to gather data on the effectiveness of this intervention in managing the condition and improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have had at least one documented episode of typical atrial flutter.

Not a fit: Patients with prior cavo-tricuspid isthmus ablation or those with unstable angina or severe heart function limitations may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective option for patients with atrial flutter, potentially reducing symptoms and improving quality of life.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in the treatment of atrial arrhythmias, indicating potential for success.

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.

Where this trial is running

Beijing, Beijing Municipality

• Fuwai Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Haitao Yang

Conditions Typical Atrial Flutter; Atrial Fibrillation