A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Yangxin Dingji Capsules in Preventing Recurrence after Radiofrequency Catheter Ablation for Atrial Fibrillation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2026001450

Enrollment

Unknown

Registered

2026-06-10

Start date

2026-06-30

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Interventions

Treatment group:guideline-directed anticoagulant and anti-arrhythmic drug therapy plus oral Yangxin Dingji Capsules,6 capsules twice daily for 3 months

Control group:guideline-directed anticoagulant and anti-arrhythmic drug therapy plus oral placebo,6 capsules twice daily for 3 months

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1)Aged 18–75 years, both sexes eligible; (2) Meets diagnostic criteria for recurrence after radiofrequency catheter ablation (RFCA) for atrial fibrillation, with recurrence occurring 3 months to 1 year following a single RFCA procedure; (3) Meets diagnostic criteria for the TCM pattern "palpitations due to qi and yin deficiency"; (4) No plan to undergo repeat cardiac RFCA; (5) Voluntary participation with signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Concomitant structural heart disease, acute coronary syndrome, or similar conditions; (2) Severe hepatic or renal insufficiency, active malignancy, hematologic disorder, acute infectious disease, or the like; (3) Life expectancy < 12 months; (4) Participation in another clinical trial within 1 month prior to enrollment, or known hypersensitivity to any component of Yangxin Dingji Capsules; (5) Severe cognitive impairment or any other condition precluding reliable communication; (6) Women who are planning pregnancy, pregnant, or breastfeeding.

Design outcomes

Primary

Measure	Time frame
1-year atrial fibrillation progression rate;	—

Secondary

Measure	Time frame
Atrial fibrillation episode frequency and duration;Atrial fibrillation load;LAAPD,LAVI,LVEF;NT-proBNP; Atrial Fibrillation Effect on QualiTy-of-life ;Score of CHA2DS2-VASc-60 and HAS-BLED ;TCM syndrome score;major adverse cardiovas-cular and cerebrovascular events;	—

Countries

China

Contacts

Public ContactLin Shen

Department of Cardiology Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

cathylin927@126.com18917763262

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 29, 2026