ventricular arrhythmia
Conditions
Interventions
group of frequent premature ventricular constractions:pulsed field ablation
group of ventricular tachycardia:pulsed field ablation
Sponsors
WEST CHINA HOSPITAL,SICHUAN UNIVERSITY
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age:18-75 years old (inclusive); 2. Clinical diagnosis: 1) Frequent ventricular premature beats (24-hour ventricular premature beats account for more than 10% of total heart beats); 2) Uniform persistent ventricular tachycardia; 3) A history of malignant ventricular arrhythmias such as polymorphic persistent ventricular tachycardia, ventricular flutter, and ventricular fibrillation, with indications for radiofrequency ablation treatment. Patients who meet one of the above three conditions, have indications for radiofrequency ablation, and plan to undergo pulsed electric field ablation surgery; 3. I voluntarily participated in this experiment and signed an informed consent form; 4. Willing to follow the relevant requirements of this experiment and cooperate in completing the corresponding follow-up; 5. If the selected patients have indications for implantable cardioverter defibrillator (ICD), this study requires that the patients have already implanted ICD or agree to cooperate with the recent implantation of ICD.
Exclusion criteria
Exclusion criteria: 1. Ventricular arrhythmia caused by electrolyte imbalance, reversible or non cardiac factors; 2. Severe left ventricular enlargement (left ventricular anterior posterior diameter>80mm); 3. Left ventricular ejection fraction (LVEF)<20%; 4. Uncontrolled heart failure, currently classified as Grade IV in the New York Heart Function Classification (NYHA); 5. Participants who have undergone previous cardiac surgeries such as patent foramen ovale occlusion, left atrial appendage occlusion, heart valve related surgeries such as heart valve repair/replacement, or other cardiac surgeries that are not suitable for catheter ablation; 6. Participants with significant congenital abnormalities in cardiac anatomy that hinder the entry of the ablation catheter into the target ablation area; 7. Participants who plan to undergo cardiac related surgeries such as heart transplantation, left atrial appendage occlusion, patent foramen ovale occlusion, or other major surgeries that affect ablation treatment within the next 12 months; 8. Participants with intracardiac thrombosis, myxoma, occluder, or other conditions that hinder catheter insertion or operation; 9. Participants with serious obstruction of vascular access (such as implanted inferior vena cava filters, intramural thrombosis, etc.); 10. Participants with active systemic infections; 11. There is uncontrolled hypertension (continuous systolic blood pressure = 180mmHg or continuous diastolic blood pressure = 110mmHg); 12. Participants with severe liver and kidney dysfunction; 13. Screening participants with a history of systemic thromboembolism (including TIA) within the previous month; 14. Screening participants with unstable angina or participants who have experienced acute myocardial infarction within the first three months; 15. Select participants who have undergone percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within the first three months; 16. Participants who are currently participating in clinical studies of other devices or drugs before screening; 17. Participants of women of reproductive age who are pregnant, breastfeeding, or planning to conceive; 18. Participants with a life expectancy of less than 12 months; 19. Other participants who have been determined by the researchers to be unsuitable for participation in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| immediate success rate of PFA;long-term success rate of PFA(1st month,,3rd month,6th month,12th month);the incidence of death,stroke or TIA;the incidence of PFA-related complications,for example:vascular puncture complications, heart perforation,left atrial esophageal fistula,phrenic nerve injury and so on;clinically significant vital signs and related rests;the incidence of other adverse events and serious adverse events during the experimental period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Holter ECG; | — |
Countries
China
Contacts
Public ContactHongde Hu
WEST CHINA HOSPITAL,SICHUAN UNIVERSITY
Outcome results
None listed