Atrial Fibrillation
Conditions
Keywords
atrial fibrillation
Brief summary
The study is designed as a randomized control trial. The purpose of this study is to observe the efficacy and safety of atrial fibrillation ablation, comparing circumferential pulmonary vein isolation (CPVI) plus renal sympathetic modification (RSM) with CPVI alone.
Detailed description
Basic studies suggested that sympathetic nerves over-activity played an important role in the pathophysiological changes of arrhythmia occurrence. Present studies of renal ablation show a new method to decrease sympathetic nerves activity. Circumferential pulmonary vein isolation (CPVI) is an accepted ablation method for atrial fibrillation. The investigators plan to evaluate the efficiency and safety of CPVI plus renal sympathetic modification for atrial fibrillation ablation comparing with CPVI alone. The trial is going to recruit 100 patients randomized into two groups (CPVI+RSM group VS CPVI group = 50:50) with a follow-up duration of 4 years. The investigators aim to observe the relapse of atrial tachyarrhythmia lasting more than 30 seconds, the incidence of composite cardiovascular events after renal sympathetic modification, and safety and efficacy of the intervention, comparing with CPVI alone.
Interventions
PROCEDURECPVI plus renal sympathetic modification
CPVI plus renal denervation to reduce atrial arrhythmia recurrence.
PROCEDURECPVI
CPVI alone to reduce atrial arrhythmia recurrence.
Sponsors
The Second Affiliated Hospital of Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* • ≥ 18 years old, and ≤ 75 years old of age * more than half a year history of atrial fibrillation, no matter paroxysmal or persistent, with clinical symptom or ECG proved * be ineffective to at least one kind of anti-arrhythmic drugs treatment * echocardiography has done to except structural heart diseases such as congenital, valvular heart diseases and kinds of cardiomyopathy * estimated glomerular filtration rate (eGFR) of ≥ 45ml/min * is competent and willing to provide written, informed consent to participate in this clinical study
Exclusion criteria
* • transesophageal echocardiography found thrombus in left atrial appendage * past history of atrial fibrillation surgical maze procedure * estimated glomerular filtration rate (eGFR) of \< 45mL/min * has the history of renal restenosis or renal stents implantation * has experienced AMI（acute myocardial infarction） (old myocardial infarction is not excluded), unstable angina pectoris, cerebrovascular accidents, and alimentary tract hemorrhage within 3 months * patients with sick sinus syndrome * pregnant women * mental disorders * patients that have allergy to contrast agent * patients that do not go with follow-up * others such as researcher considers it is not appropriate to be included into the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The relapse rate of atrial tachyarrhythmia | Four years | Atrial tachyarrhythmia lasting more than 30 seconds consider relapsed |
Countries
China
Contacts
Primary ContactYuehui Yin, MD
Outcome results
None listed