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New treatment option for Typical Atrial Flutter
Official title An Exploratory Study of Focal Pulse Ablation System in the Treatment of Atrial Arrhythmia
ClinicalTrials.gov ID: NCT06157437
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people aged at least 18;
- people 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...
- people are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to...
You likely can't join if
- 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;
See the full eligibility criteria
- people aged at least 18;
- people 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;
- people 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.