Atrial Fibrillation
Conditions
Interventions
Experimental Group:Standard Western pharmacotherapy plus Shengmai Dingji Formula granules
Control Group:Standard Western Pharmacotherapy
Sponsors
Beijing Chao-yang Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1: Patients diagnosed with atrial fibrillation (AF) in accordance with the Chinese Guidelines for the Diagnosis and Treatment of Atrial Fibrillation; 2: First-time radiofrequency ablation for atrial fibrillation (AF); 3: Age = 18 years; 4: Signed informed consent form obtained.
Exclusion criteria
Exclusion criteria: (1) Patients presenting with severe pulmonary disease, hepatic or renal dysfunction (ALT/AST >1.5× upper limit of normal [ULN], Cr > normal value), severe anemia or thrombocytopenia, hyperthyroidism, or malignant tumors; (2) Patients who experienced serious intraoperative or postoperative complications (e.g., cardiac tamponade) or were found to have left atrial thrombus; (3) Patients with mechanical or bioprosthetic heart valves; (4) Patients with impaired left ventricular function (left ventricular ejection fraction <40%); (5) Patients who experienced a stroke within the past 6 months; (6) Patients allergic to anticoagulant medications; (7) Patients unwilling or unable to comply with the protocol requirements, or those deemed by the investigator to have conditions that may affect safety participation (e.g., drug addiction, alcoholism); (8) Pregnant or breastfeeding women, or those planning pregnancy; (9) Patients who participated in another clinical drug trial within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Atrial fibrillation (AF) recurrence rate at 6 months post-treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first atrial fibrillation (AF) recurrence within 3 months post-treatment;Atrial fibrillation (AF) recurrence rate at 3 and 12 months post-ablation;Atrial fibrillation (AF) burden at 3, 6, and 12 months post-treatment;Traditional Chinese Medicine (TCM) symptom scores at baseline and at 3, 6, and 12 months post-treatment;Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire scores at baseline and at 3, 6, and 12 months post-treatment;Generalized Anxiety Disorder-7 (GAD-7) questionnaire scores at baseline and at 3, 6, and 12 months post-treatment;Patient Health Questionnaire-9 (PHQ-9) scores at baseline and at 3, 6, and 12 months post-treatment;Left atrial anteroposterior diameter at baseline and at 3, 6, and 12 months post-treatment;High-sensitivity C-reactive protein (hs-CRP), B-type natriuretic peptide (BNP), and interleukin-6 (IL-6) levels at baseline and at 3 months post-treatment; | — |
Countries
China
Contacts
Public ContactDongZhenyu
Beijing Chao-yang Hospital, Capital Medical University
Outcome results
None listed