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A Prospective Multicenter Clinical Study on Tongmai Yangxin Pills for the Prevention of Early Recurrence After Radiofrequency Catheter Ablation for Persistent Atrial Fibrillation

A Prospective Multicenter Clinical Study on Tongmai Yangxin Pills for the Prevention of Early Recurrence After Radiofrequency Catheter Ablation for Persistent Atrial Fibrillation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001315
Enrollment
Unknown
Registered
2026-05-26
Start date
2026-05-28
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Atrial fibrillation

Interventions

Intervention group:Tongmai Yangxin Pills plus amiodarone

Sponsors

Renmin Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Participants aged 18–75 years; diagnosed with persistent atrial fibrillation of the qi-and-yin deficiency pattern; duration of atrial fibrillation < 5 years; undergoing first-time radiofrequency catheter ablation; willing to participate in the study and having signed the informed consent form.

Exclusion criteria

Exclusion criteria: Valvular atrial fibrillation NYHA class IV or LVEF 50 mm Moderate-to-severe left ventricular hypertrophy (wall thickness > 1.5 cm) Patients with acute coronary syndrome or those requiring stent implantation History of cardiac surgery within the past 6 months or prior catheter ablation Duration of atrial fibrillation = 5 years Hyperthyroidism Atrial fibrillation associated with cardiomyopathy Bradyarrhythmia requiring pacemaker implantation Valvular atrial fibrillation; known bleeding tendency; presence of left atrial/left atrial appendage thrombus; or severe hemostatic/coagulation dysfunction Severe hepatic or renal insufficiency [ALT = 3 × ULN or eGFR < 45 mL/min/1.73 m²] Neurological or psychiatric disorders Allergy to any component of the study medication Pregnant or breastfeeding women Patients currently participating in other clinical studies Patients considered by the investigators to be unsuitable for participation in this study Contraindication to amiodarone use Concomitant use of other medications that may affect the results of the present study

Design outcomes

Primary

MeasureTime frame
An episode of rapid atrial tachyarrhythmia lasting =30 seconds within 90 days after atrial fibrillation ablation;

Secondary

MeasureTime frame
The variation of atrial fibrillation burden;Time to first recurrence of atrial flutter/atrial fibrillation;Rate of electrical cardioversion;Changes in transthoracic echocardiography parameters;Rate of stroke and thromboembolic events;Short Form-36 Health Survey (SF-36) score, Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score, and EHRA classification;Palpitation symptom score;

Countries

China

Contacts

Public ContactHe Huang

Renmin Hospital of Wuhan University

huanghe1977@whu.edu.cn13986161018

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026