Atrial Fibrillation
Conditions
Interventions
Intervention Group:Pulsed Field Ablation
Sponsors
The First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Patient age >= 18 years old, gender is not limited; (2) Patients with symptomatic drug-refractory atrial fibrillation; (3) Agree to participate in the study and be able and willing to comply with all follow-up requirements.
Exclusion criteria
Exclusion criteria: (1) Left ventricular ejection fraction (LVEF) = 55mm; (3) Preoperative finding of definite thrombus in the left atrium or definite thrombus in the heart; (4) Heart failure associated with New York Heart Association (NYHA) Class ?-?; (5) Second degree type II or third degree atrioventricular block; (6) Obvious congenital heart defects; (7) Implanted prosthetic valves; (8) Implanted pacemakers or cardiac defibrillators (ICDs); (9) Diagnosis of hypertrophic cardiomyopathy, chronic obstructive pulmonary disease, mucinous tumors; (10) Preoperative known symptomatic carotid stenosis; (11) Untreated or uncontrolled hyperthyroidism or hypothyroidism; (12) Active systemic infections; (13) Patients with renal failure who have a marked tendency to bleed or are on hemodialysis; (14) Patients who have had a myocardial infarction or any interventional/open heart surgery within 3 months; (15) Patients who have had a stroke or transient ischemic attack within 6 months; (16) Patients with significant contraindications to interventional procedures that are determined to be inoperable by the investigator; (17) Females who are pregnant or breastfeeding or who are planning to have children during the study period; (18) Patients who have participated in a clinical trial of another drug or medical device within 3 months; (19) Patients with other conditions deemed inappropriate by the investigator to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| treatment success rate within 3 months (early recurrence);Treatment success rate within 12 months (late recurrence); | — |
Secondary
| Measure | Time frame |
|---|---|
| acute ablation success rate; | — |
Countries
China
Contacts
Public ContactChen Minglong
The First Affiliated Hospital of Nanjing Medical University
Outcome results
None listed