Renal Sympathetic Denervation in Patients With Drug-resistant Hypertension and Symptomatic Atrial Fibrillation (RSDforAF)
Hypertension, Atrial Fibrillation
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases
Eligibility Criteria
Inclusion Criteria:
- Individual is ≥18 and ≤75 years of age
- More than half a year for definite primary hypertension
- Individual has a systolic blood pressure ≥160 mmHg (≥150 mmHg for type 2 diabetics) based on an average of three office blood pressure readings measured
- Individual is adhering to a stable drug regimen, including three or more antihypertensive medications of which one is a diuretic, for a minimum of 14 days prior to enrollment
- At least 30 seconds on a rhythm strip in an ECG record and at least 1 AF outbreak which was recorded by EGG and Holter during the preceding 6 months
- Paroxysmal and persistent AF individual
- Agree to attend experimental clinic and sign written informed consent
Exclusion Criteria:
- Secondary and white-coat hypertension
- Permanent AF individual
- Thrombus in left atrial appendage found by transesophageal echocardiography
- Individual with severely enlarged left atria ≥55 mm
- Individual has experienced renal artery stenosis, or a history of prior renal artery intervention including balloon angioplasty or stenting, or ineligible conditions seen on renal artery computed tomography angiogram inspection such as double renal artery on one side, renal artery length ≤2 cm, diameter ≤4 mm, and distortion at incept sect
- Individual has experienced a definite acute coronary syndrome in the past 3 months, or a cerebrovascular accident and alimentary canal bleeding within 3 months
- Individual has experienced sick sinus syndrome
- reversible causes of AF, including alcohol abuse, surgery, electrocution, myocadial infarction, pericarditis, myocarditis, pulmonary embolism or other pulmonary diseases, hyperthyroidism, and other metabolic disorders
- structural heart diseases such as congenital, valvular heart diseases and kinds of cardiomyopathy
- Individual is pregnant or nursing
- Mental disorders - individual cannot complete follow-up or one the researcher thinks is unfit to be included in this study
Sites / Locations
- First Affiliated Hospital of Nanjing Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
renal sympathetic denervation
drug therapy
Contrast renal angiography was performed to localize and assess the renal arteries. Once the anatomy was deemed acceptable, the internally irrigated radiofrequency ablation catheter was introduced into each renal artery. This was then maneuvered within the renal artery to allow energy delivery in a circumferential, longitudinally staggered manner to minimize the chance of renal artery stenosis. About four to eight ablations at 10 W for 60 seconds each were performed in both renal arteries. After renal sympathetic denervation, patients with persistent AF accepted direct-current cardioversion immediately.
Patients in the drug treatment group will be followed-up at 3, 6, 9 and 12 months after randomization. All the patients in this group will take their baseline antihypertensive medication at the original doses, without any changes except when medically required. Antiarrhythmic drugs treatment is consistent in both arms.