Tests a focal pulse ablation device for atrial flutter and atrial fibrillation
Tests a focal pulse ablation device to treat typical atrial flutter in adults.
Plain-language title generated from the registry record
Registry title: An Exploratory Study of Focal Pulse Ablation System in the Treatment of Atrial Arrhythmia
Key facts
- Where
- Beijing, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who have had typical atrial flutter recorded on an ECG or Holter in the past 180 days. It tests a pulse ablation device for the heart.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- At least one typical atrial flutter attack recorded by ECG or Holter in the 180 days before enrollment. ECGs from other hospitals are accepted.
- Earlier treatment
- No earlier ablation of the cavo-tricuspid isthmus.
Main reasons for not taking part
- Prior cavo-tricuspid isthmus ablation
- Heart attack, bypass surgery or stent procedure in the past three months
- Heart failure grade III or IV (NYHA)
- Pacemaker, ICD or CRT device in the body
- Pregnant or breastfeeding women, or women who cannot use contraception during the study
Read by machine on 9 November 2026.
Where in China
- Fuwai Hospital Chinese Academy of Medical SciencesBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hangzhou Dinova EP Technology Co., Ltd
- Trial code
- NCT06157437
- Record updated
- 11 February 2025
- Original description
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.Read full original descriptionShow less
An Exploratory Study of Focal Pulse Ablation System in the Treatment of Atrial Arrhythmia
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.
Inclusion: 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: Any prior cavo-tricuspid isthmus ablation; Myocardial infarction or coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within the prior three months; Atrial or ventricular tumors, blood clots, thrombus, or known clotting disorders were recorded within the prior 90 days; Previously received tricuspid metal valve replacement; Enrollment in another clinical trial evaluating other devices or drugs during the same period; Unstable angina; Atrial flutter secondary to electrolyte disorder, thyroid disease or other reversible causes; At baseline, New York College of Cardiology (NYHA) heart function grades III and IV; Severe structural heart disease, including tricuspid stenosis, tricuspid malformation, or other congenital heart disease that prevents ablation surgery; 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; 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; Serum creatinine greater than twice the upper limit of normal, or any history of renal dialysis; Implantable devices such as ICDs, CRTS and pacemakers in the body; Thromboembolic events (including transient ischemic attacks) within the past 6 months; Women who are pregnant or breastfeeding or who cannot use contraception during the study period.