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

Study Overview
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Brief Summary
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To verify the safety and effectiveness of the renal artery radiofrequency ablation system under the guidance of the three-dimensional cardiac electrophysiological mapping system in the renal denervation of essential hypertension.

Detailed Description
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This trial is a prospective, multi-center, randomized controlled clinical study to verify the safety and efficacy of the renal artery radiofrequency ablation system under the guidance of the three-dimensional cardiac electrophysiological mapping system in the application of renal denervation of essential hypertension. Provide the basis for product registration and marketing and clinical application. This trial plans to include 206 subjects, of which 5 are subjects trained and taught by the experimental group leader unit center, and 201 subjects are randomly assigned according to 2:1 (134 cases in the renal artery ablation group and 67 cases in the simple drug treatment group). Patients will be followed for blood pressure measurement and antihypertensive medication at 7 days, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, and 12 months after the procedure. Patients' urine samples will be collected for drug testing (LC-MS/MS) to determine their medication compliance in an independent laboratory.

Official Title
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3D Cardiac Electrophysiological Mapping System on Renal Artery Radiofrequency Ablation System for Hypertension: a Prospective, Multicenter, Randomized Controlled Trial

Conditions
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Hypertension

Intervention / Treatment
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* Device: FlashPoint renal denervation system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females aged ≥18 and ≤65 (not pregnant, breastfeeding, and have no reproductive plan within one year); Patients with essential hypertension, antihypertensive drug intolerance, and willing to undergo surgical treatment; Ambulatory blood pressure measurement 24-hour average systolic blood pressure ≥130mmHg or daytime ≥135mmHg or nighttime ≥120mmHg, and pulse pressure difference <80 mmHg; A history of using 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: Renal artery diameter <4mm or treatment length <20mm; Possess multiple renal arteries, and the main renal artery provides <75% of blood supply; Renal artery stenosis >50% or renal aneurysm on either side; 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, the patient used antihypertensive drugs other than the standard antihypertensive drugs prescribed in this study protocol; Nocturnal sleep apnea syndrome requires breathing chronic oxygen or mechanical ventilation (such as tracheostomy); Patients with contraindications to renal artery stimulation or ablation; Those who have or are currently suffering from the following diseases or conditions: Primary pulmonary hypertension (moderate to severe); Type I diabetes; History of any cerebrovascular events (eg, stroke, transient cerebral ischemic event, cerebrovascular accident) within 3 months; History of any serious cardiovascular event within 3 months (eg, myocardial infarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV), unstable angina attack); 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); Arranged or planned surgery or cardiovascular intervention within the next 6 months; Patients with malignant tumors and end-stage diseases; Patients who are deemed inappropriate to participate in this trial by other investigators.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal Denervation<br>Percutaneous renal denervation using the FlashPoint radio-frequency ablation system under the Columbus 3D mapping system guidance | Device: FlashPoint renal denervation system<br>* Radio-frequency ablation of renal arterial sympathetic nerves<br>|
| No Intervention: Control<br>Maintenance of anti-hypertensive medications | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour ambulatory mean systolic blood pressure reduction | The primary effectiveness endpoint is change in 24-hour ambulatory mean systolic blood pressure from baseline to 6 months post-randomization | Baseline to 6 months |