Circumferential Pulmonary Vein Isolation (CPVI) Plus Renal Sympathetic Modification Versus CPVI Alone for AF Ablation: a Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- The relapse rate of atrial tachyarrhythmia
- Last Updated
- 7 years ago
Overview
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.
Investigators
Yuehui Yin
Director and Professor, Dept. of Cardiology, the second affiliated hospital of Chongqing Medical University, Chongqing Cardiac arrhythmias service center
The Second Affiliated Hospital of Chongqing Medical University
Eligibility Criteria
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
Outcomes
Primary Outcomes
The relapse rate of atrial tachyarrhythmia
Time Frame: Four years
Atrial tachyarrhythmia lasting more than 30 seconds consider relapsed