Effect of Acupuncture on Quality of Life in Patients With Atrial Fibrillation: A Randomized Controlled Trial
Not Applicable
- Conditions
- Atrial fibrillation
- Registration Number
- ITMCTR2100005111
- Lead Sponsor
- Beijing University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
1.Paroxysmal or persistent AF after ablation (Radiofrequency ablation or Cryoablation);
2.Aged 18 years or above (male or female);
3.No acupuncture treatment within the previous 6 months;
4.Cooperating with 12 weeks treatment and follow-up.
Exclusion Criteria
1.Severe heart failure (New York Heart Association(NYHA)class III or IV);
2.Echocardiographic parameters: left ventricular ejection fraction <35%, left atrium diameter >5.5cm;
3.Severe lung, liver, kidney disease or other serious primary disease;
4.Skin allergy to ECG monitoring electrode patch.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of quality of life;
- Secondary Outcome Measures
Name Time Method Recurrence of atrial fibrillation after ablation;Heart rate variability;Number of hospitalizations related to arrhythmia;Atrial fibrillation burden at 3, 6 and 12 months after catheter ablation;Changes in the overall score of the Atrial fibrillation Specific Quality of Life Scale from baseline at 3 and 12 months;Changes of the AFEQT subscale scores in the following 3 domains: symptoms, daily activities, and treatment concern compared to baseline at 3,6 and 12 months.;Average heart rate;Symptoms and functional capacity assessed using the modified EHRA classification system;Rate of repeat catheter ablation;Number of electrical cardioversion within 3 months after catheter ablation;