Hypertension complicated with Atrial Fibrillation
Conditions
Interventions
Intervention group (RDN group):Renal Denervation (RDN)
Control group (medication group):Medication
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Male or female subjects aged 18 = 2 adequate-dose antihypertensive drugs continuously and stably for at least 4 weeks, with office blood pressure >= 140/90 mmHg and = 130 mmHg and =30 seconds and <7 days) and not receiving any type of antiarrhythmic drugs. 4.The subject or his/her legally authorized representative has fully understood the content of the informed consent for this trial and voluntarily signed the written informed consent form.
Exclusion criteria
Exclusion criteria: 1.Pregnancy or planned pregnancy. 2.Unilateral or bilateral renal artery anatomy unsuitable for ablation (renal artery stenosis >50%, renal artery aneurysm, renal artery malformation, renal artery diameter = 5 cm. 5.Secondary hypertension (e.g., primary aldosteronism, pheochromocytoma/paraganglioma, Cushing’s syndrome, thyroid disease, aortic coarctation, monogenic hypertension, renovascular hypertension, etc.). 6.Hypersensitivity to contrast media. 7.Major surgery or trauma within 3 months prior to enrollment history of acute coronary syndrome (unstable angina, ST-elevation myocardial infarction, non-ST-elevation myocardial infarction) within 6 months or planned surgery or cardiovascular intervention within the next 6 months. 8.Orthostatic hypotension. 9.Hypertrophic cardiomyopathy, restrictive cardiomyopathy. 10.Type 1 diabetes mellitus. 11.Idiopathic pulmonary arterial hypertension. 12.Significant bleeding tendency or hematological disease (platelet count 3×upper limit of normal (ULN) or international normalized ratio (INR) >1.5). 13.History of thromboembolism within 6 months. 14.History of stroke or transient ischemic attack (TIA) within 6 months. 15.Severe peripheral vascular disease, abdominal aortic aneurysm. 16.Severe valvular heart disease. 17.History of ventricular fibrillation, multifocal or polymorphic ventricular tachycardia, or prior implantation of an implantable cardioverter-defibrillator (ICD) or cardiac pacemaker. 18.Severe liver dysfunction (alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin >3×ULN). 19.Presence of other severe diseases that would preclude enrollment or affect survival, such as malignant tumor or acquired immunodeficiency syndrome (AIDS). 20.Acute or severe systemic infection. 21.Diseases that frequently cause high-output state, such as anemia, liver disease, hyperthyroidism, arteriovenous fistula, etc. 22.Any other condition deemed inappropriate by the investigator for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Documentation of antihypertensive and antiarrhythmic medications;Device usage;Changes in Atrial Fibrillation Burden;Change in ambulatory and office blood pressure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Daily Atrial Fibrillation Duration (MDAFD), Sinus rhythm duration in monitoring period,Frequency of atrial fibrillation episodes during the monitoring period;Incidence rate of composite major adverse events (MAE) related to the study device and/or ablation procedure from surgery up to 30 days postoperatively;Incidence rate of adverse events,Incidence rate of device deficiencies;Change in EHRA symptom class;Proportion of hospitalizations/emergency department visits due to AF recurrence; | — |
Countries
China
Contacts
Public ContactGe Junbo
Zhongshan Hospital, Fudan University
Outcome results
None listed