Persistent Atrial Fibrillation Clinical Trial
— PFA,RFA,PeAFOfficial title:
A Single-Center, Exploratory Clinical Study Combining Radiofrequency and Pulsed Field Ablation for Persistent Atrial Fibrillation Based on Columbus™ 3D EP Navigation System
The goal of this clinical trial is to treatment of patients with persistent atrial fibrillation with PFA/RFA. 10 patients will be treated by PFA/RFA catheter or PFA catheter only. Participants will followed 1、3 month after catheter ablation
Status | Recruiting |
Enrollment | 10 |
Est. completion date | August 31, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Aged 18-75 years old; 2. Documented symptomatic persistent atrial fibrillation, defined as persistent atrial fibrillation lasting more than 7 days and less than 1 year; 3. Ineffective or intolerable after treatment with at least one Class I or Class III antiarrhythmic drug; 4. Fully understand the treatment protocol and voluntarily sign the informed consent form and be willing to undergo the tests, procedures and follow-ups required by the protocol. Exclusion Criteria: 1. Patients who have undergone left atrial surgery 2. Left atrial thrombosis 3. Patients with combined atrial tachycardia and atypical atrial flutter 4. Patients of childbearing age who are unable to use effective contraception during the 3-month period following enrollment 5. Anterior and posterior left atrial diameter = 55mm 6. Left ventricular ejection fraction (LVEF) = 40% 7. Previous atrial septal repair or atrial mucinous tumor 8. Active implants (e.g. pacemakers, ICDs, etc.) in the body 9. NYHA class III-IV cardiac function 10. Clear cerebrovascular disease within the last 6 months (including cerebral hemorrhage, stroke, transient ischemic attack) 11. Cardiovascular events within the last 3 months (including acute myocardial infarction, coronary intervention or heart bypass surgery, prosthetic valve replacement or repair, atrial or ventriculotomy) 12. Those with acute or severe systemic infections 13. Patients with severe liver or kidney disease, malignant tumors or end-stage disease that, in the opinion of the investigator, may interfere with the treatment, evaluation and compliance of this trial 14. Patients with significant bleeding tendency, hypercoagulable state and severe hematologic disorders 15. Patients who have participated or are participating in other clinical trials within 3 months prior to enrollment 16. Patients who have other conditions that the investigator considers inappropriate for participation in this trial. |
Country | Name | City | State |
---|---|---|---|
China | West China Hospital of Sichuan University | Chengdu | Sichuan |
Lead Sponsor | Collaborator |
---|---|
Shanghai MicroPort EP MedTech Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Immediate success rate | Refers to the proportion of the number of subjects electrically isolated in each AF patient after surgery to the total number of subjects enrolled. | 1 Day of catheter ablation | |
Secondary | Ablation success at 3-month after the catheter ablation | Ablation success is defined as no recurrence with no anti-arrhythmic drugs by taking history of symptoms from the patient and by Holter 24 Hours. | 3 months |
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