Actively Recruiting
An Exploratory Study of Focal Pulse Ablation System in the Treatment of Atrial Arrhythmia
Led by Hangzhou Dinova EP Technology Co., Ltd · Updated on 2025-02-11
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new focal pulse ablation system for treating typical atrial flutter, a heart rhythm disorder. This prospective, single-group clinical study aims to assess the safety and effectiveness of this device in managing atrial arrhythmias. The study is sponsored by Hangzhou Dinova EP Technology Co., Ltd and focuses on patients who have experienced typical atrial flutter attacks recently recorded by ECG or Holter monitoring. The treatment involves a novel focal pulse field ablation device that performs a bidirectional block of the cavo-tricuspid isthmus (CTI). This procedure is intended to interrupt abnormal electrical signals causing atrial flutter. Participants will undergo the ablation procedure, and the study will monitor procedural success immediately afterward, as well as ablation efficiency factors such as procedure time and X-ray exposure. Participants will be followed up for safety and effectiveness over a period extending to six months post-procedure. Researchers will assess acute procedural success immediately after treatment and chronic success at six months. Safety monitoring includes tracking device-related major and severe adverse events within days and months after the ablation. The study involves clinical evaluations and imaging to ensure patient well-being and treatment monitoring.
CONDITIONS
Brief Title
An Exploratory Study of Focal Pulse Ablation System in the Treatment of Atrial Arrhythmia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Subjects able to understand the study purpose, voluntarily participate, sign informed consent, and complete follow-up as required
You will not qualify if you...
- Prior cavo-tricuspid isthmus ablation
- Unstable angina
- Atrial flutter due to reversible causes like electrolyte disorder or thyroid disease
- Myocardial infarction, coronary artery bypass grafting, or percutaneous coronary intervention within 3 months
- NYHA heart function grades III and IV at baseline
- Presence of implantable devices such as ICDs, CRTS, or pacemakers
- Atrial or ventricular tumors, blood clots, thrombus, or clotting disorders within 90 days
- Severe structural heart disease preventing ablation
- Previous tricuspid metal valve replacement
- Thromboembolic events within past 6 months
- Abnormalities interfering with vascular puncture or catheter operation
- Severe lung disease or pulmonary hypertension with abnormal blood gas or severe breathing issues
- Anticoagulation contraindications or history of abnormal bleeding
- Acute systemic infection
- Serum creatinine greater than twice upper normal limit or history of renal dialysis
- Pregnant, breastfeeding, or unable to use contraception during study
- Enrollment in another clinical trial with devices or drugs
- Life expectancy less than 12 months
- Other abnormalities or diseases deemed exclusionary by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo focal pulse field ablation to treat atrial arrhythmia using a novel device.
1 procedure visit (in-person)
Duration - 6 months
Participants are monitored for device-related adverse events and treatment success.
Visits at 7 days, 3 months, and 6 months after the procedure
Trial Site Locations
Total: 1 location
1
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
H
Haitao Yang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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