FlashPoint Renal Denervation Under Columbus 3D Mapping System Guidance for Treating Hypertension

Inclusion Criteria:

• Males or females aged ≥18 and ≤70 (not pregnant, breastfeeding, and have noreproductive plan within one year);

• Patients with essential hypertension, antihypertensive drug intolerance, and willingto undergo surgical treatment;

• Ambulatory blood pressure measurement 24-hour average systolic blood pressure ≥130mmHg or daytime ≥135mmHg, and pulse pressure difference <80 mmHg;

• A history of using antihypertensive medication within six months and blood pressureis still uncontrollable; standardized medication (at least two drugs) for at least 28 days before enrollment, and medication compliance ≥ 80%, office systolic bloodpressure (OSBP) ) ≥ 150 mmHg and <180 mmHg, diastolic blood pressure (DBP) ≥ 90mmHg;

• The patients agree to participate in this clinical trial and sign the informedconsent form, agreeing to follow-up evaluation under the requirements of theverification protocol.

Exclusion Criteria:

• Renal artery anatomy failures include:

1. Renal artery diameter <4mm or treatment length <20mm;

2. Renal artery stenosis >50% or renal aneurysm on either side;

3. A history of renal artery intervention, including balloon angioplasty orstenting or RDN;

• Glomerular filtration rate (eGFR) <45mL/min/1.73m2 (MDRD formula);

• History of hospitalization for hypertensive crisis in the past year;

• During the screening and lead-in period, the patient used antihypertensive drugsother than the standard antihypertensive drugs prescribed in this study protocol;

• Nocturnal sleep apnea syndrome requires mechanical ventilation (such astracheostomy);

• Those who have or are currently suffering from the following diseases or conditions:

1. Primary pulmonary hypertension (moderate to severe);

2. Type I diabetes;

3. History of any cerebrovascular events (eg, stroke, transient cerebral ischemicevent, cerebrovascular accident) within 3 months;

4. History of any serious cardiovascular event within 3 months (eg, myocardialinfarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV),unstable angina attack);

5. Factors that interfere with blood pressure measurement in any case (eg,patients with severe peripheral vascular disease, abdominal aortic aneurysm,bleeding disorders such as thrombocytopenia, hemophilia, severe anemia);

6. Arranged or planned surgery or cardiovascular intervention within the next 6months;

7. Patients with malignant tumors and end-stage diseases who survival period isless than 1year;

• Patients with secondary hypertension.

• Patients who are deemed inappropriate to participate in this trial by otherinvestigators.