Sympathetic Mapping/ Ablation of Renal Nerves Trial (SMART) HTN-OFF MED Study (SMART OFF-MED)

This is an interventional treatment trial for Essential Hypertension Read More

Inclusion Criteria:

1. Male and non-pregnant female subjects, 18≤age≤65
2. Essential hypertension
3. Office SBP ≥150mmHg and < 180mmHg; and DBP ≥90mmHg
4. Average 24-hour ABPM systolic blood pressure is ≥130mmHg, or day-time mean SBP ≥135mmHg, or night-time mean SBP ≥120mmHg, and all SBP of ABMP record <170mmHg
5. HPLC-MS/MS urinary antihypertensive drugs detection shows negative result after at least two weeks of drug elution period, or one extra week of drug elution period will be given for the second urinary drugs analysis; and the urinary drugs detection can be given in screening date for the subjects without antihypertensive history
6. Renal arteries meet the criteria of renal nerve stimulation, mapping and denervation; and at least one positive-response point occurs in each renal artery
7. Patient understands the purpose of this study, and is willing to participate and sign the Informed Consent
8. Patient is compliant and willing to complete clinical follow-up.

Exclusion Criteria:

1. Renal artery anatomy is unqualified including：

1. Diameter <3.5mm or treatable length <25mm;
2. Multiple renal arteries and the main renal artery supplies a fraction of the blood flow less than 75%
3. Renal artery stenosis >50% or any renal artery aneurysms on either side
4. History of renal artery percutaneous transluminal angioplasty (PTA), including balloon angioplasty and stenting 2. eGFR <45ml/min/1.73m2 (MDRD formula) 3. Hospitalized within one year due to hypertensive crisis 4. Pulse pressure>80mmHg, or isolated systolic hypertension 5. During running in period, using any antihypertensive drugs without prescription and urinary drugs test shows positive.

6. Participated other clinical trials including both drug and medical device studies within 3 months enrollment 7. Female with pregnant or lactating, or having plans for pregnancy within 1 year 8. Patient with sleep apnea who needs chronic oxygen-breathing or mechanical ventilation support (for example, tracheostomy) 9. Patients previously or currently suffering from following diseases:

1. Essential pulmonary arterial hypertension
2. Type I diabetes
3. Severe cardiac valvular stenosis with contradictions to significantly reduce blood pressure
4. History of myocardial infraction (MI), unstable angina, syncope or cerebrovascular accidents within half year.
5. History of primary aldosteronism, pheochromocytoma, aorta stenosis, hyperthyroidism or hyperparathyroidism
6. Any disease conditions interfering the measurement of blood pressure (for instance, severe peripheral artery diseases, abdominal artery aneurysm, hemorrhagic disorders such as thrombocytopenia, hemophilia and severe anemia)
7. Plans to have surgery or cardiovascular interventions within following 6 months
8. Alcohol abuse or unknown drug dependence history
9. Neuroticisms such as depression or anxiety disorders
10. Non-compliant patients unable to finish the research per physician's requests 10. There is no positive-response point in any renal artery, or any contradictions to conduct renal artery stimulation and ablation