Idiopathic Premature Ventricular Contractions
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Eligibility Criteria 1)Diagnostic Criteria (Idiopathic Premature Ventricular Contraction, PVC) Participants must meet the diagnostic criteria for idiopathic PVCs as defined in the 2017 AHA/ACC/HRS Guideline for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death or the Chinese Expert Consensus on the Diagnosis and Treatment of Ventricular Arrhythmias (2021). The diagnosis should be established after exclusion of structural heart disease and secondary causes, and must satisfy all of the following: Characteristics of Arrhythmia: 24-hour Holter ECG confirms the presence of PVCs, which may be monomorphic or polymorphic, with or without non-sustained ventricular tachycardia (hemodynamically stable). Normal Cardiac Structure and Function: Echocardiography: Left ventricular ejection fraction (LVEF) = 50%; normal chamber size, wall thickness, wall motion, and valvular function; no evidence of structural heart disease. Standard 12-lead ECG: Except for PVCs, there are no ischemic changes, pathological Q waves, ventricular hypertrophy, or Brugada-type patterns. Exclusion of Secondary Causes: Coronary Artery Disease (CAD): For participants with =2 major cardiovascular risk factors (hypertension, diabetes, dyslipidemia, smoking, family history of premature cardiovascular disease, or judged as high-risk by physicians), CAD is excluded only if one of the following is met: • Negative exercise ECG (achieving =85% of predicted maximal heart rate without ischemic changes); • Coronary CT angiography (CCTA) showing no significant stenosis (3,000 PVCs/24h; Persistent symptoms: Symptom burden remains and patient seeks improvement; Treatment compliance: Participant agrees to maintain the current medication regimen throughout the study period, without dose change or additional antiarrhythmic agents. Informed Consent: The participant fully understands the study nature, purpose, procedures, potential risks, and benefits, and voluntarily signs written informed cons
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1)Severe or High-Risk Arrhythmias: History of sustained ventricular tachycardia or ventricular fibrillation; non-sustained ventricular tachycardia causing hemodynamic instability; patients requiring or having an implanted cardioverter-defibrillator (ICD); untreated significant sinus node dysfunction or advanced atrioventricular block. 2)Severe or Uncontrolled Comorbidities: Uncontrolled severe hypertension or diabetes mellitus (e.g., HbA1c > 8.5%); significant thyroid disorders; active and severe hepatic or renal dysfunction; malignant tumors with limited life expectancy. 3)Significant Uncorrected Electrolyte Imbalance. 4)Pregnancy or Lactation: Pregnant or breastfeeding women, or women planning pregnancy during the study period without adequate contraceptive measures. 5)Severe Psychiatric or Cognitive Disorders: Any mental or cognitive impairment that affects comprehension, compliance, or accurate symptom reporting. 6)Contraindications to Acupuncture: Severe bleeding tendency or unstable anticoagulation (e.g., INR > 3.0); extreme fear of acupuncture; severe skin lesions or infections at the intended acupuncture sites. 7)Severe Allergic History: Known severe allergy to materials used in acupuncture needles or disinfectants applied in the study. 8)Participation in Other Interventional Clinical Trials: Concurrent enrollment in other interventional clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total number of Premature Ventricular Contractions on 24-hour Holter; | — |
Secondary
| Measure | Time frame |
|---|---|
| Premature Ventricular Contractions Burden;Visual Analogue Scale Score;Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia,ASTA;SF-36 scale;Traditional Chinese Medicine Pattern Score; | — |
Countries
China
Contacts
The Sixth Medical Center of Chinese PLA General Hospital