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

This is an interventional treatment trial for Hypertension Read More

Inclusion Criteria:

• Males or females aged ≥18 and ≤65 (not pregnant, breastfeeding, and have no reproductive plan within one year);
• Patients with essential hypertension;
• Ambulatory blood pressure measurement 24-hour average systolic blood pressure ≥130mmHg or daytime ≥135mmHg or nighttime ≥120mmHg, and pulse pressure difference <80 mmHg;
• There is a history of antihypertensive medication within six months, and blood pressure is still uncontrollable; standardized medication (at least two drugs) for at least 28 days before enrollment, and medication compliance ≥ 80%, office systolic blood pressure (OSBP) ) ≥ 150 mmHg and <180 mmHg, diastolic blood pressure (DBP) ≥ 90 mmHg;
• The patients agree to participate in this clinical trial and sign the informed consent form, agreeing to follow-up evaluation under the requirements of the verification protocol.

Exclusion Criteria:

• Renal artery anatomy failures include:

  1. Renal artery diameter <4mm or treatment length <20mm;
  2. Possess multiple renal arteries, and the main renal artery provides <75% of blood supply;
  3. Renal artery stenosis >50% or renal aneurysm on either side;
  4. A history of renal artery intervention, including balloon angioplasty or stenting;
• 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, other antihypertensive drugs other than the standard antihypertensive drugs prescribed in this study and the adjustment plan were used in combination;
• Nocturnal sleep apnea syndrome requires breathing chronic oxygen or mechanical ventilation (such as tracheostomy);
• Patients with contraindications to renal artery stimulation ablation;

• 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. Any history of cerebrovascular events (such as stroke, transient cerebral ischemic event, cerebrovascular accident) within 3 months;
  4. History of any serious cardiovascular event within 3 months (eg myocardial infarction, 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 6 months;
  7. Patients with malignant tumors and end-stage diseases;
• Patients with secondary hypertension;
• Patients who are considered inappropriate by other investigators to participate in this trial.