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

Shanghai Hongdian Medical

Status: Enrolling

Conditions: Hypertension

Treatments: Device: FlashPoint renal denervation system; Other: Sham

Study type: Interventional

Funder types: Industry

Identifiers

NCT05590871

714156A

Details and patient eligibility

About

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.

Full description

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，designed to include drug-control research and sham-control resarch. Provide the basis for product registration and marketing and clinical application. Drug-control research include 65 subiects (5 are subjects trained and taught by the experimental group leader unit center, 40 subjects are randomly to the renal artery ablation with durg treatment group, 20 subjects to the drug treatment group). Sham-control research include 180 subjects, will be randomly assigned according to 2:1 (120 subjects in the renal artery ablation with drug treatment group and 60 subjects in the sham procedure with drug treatment group).

Patients will be followed for blood pressure measurement and antihypertensive medication at 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females aged ≥18 and ≤70 (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, 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:

  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 or stenting 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 drugs other than the standard antihypertensive drugs prescribed in this study protocol;

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

• 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 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 who survival period is less than 1year;

• Patients with secondary hypertension.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Renal Denervation

Experimental group

Description:

Percutaneous renal denervation using the FlashPoint radio-frequency ablation system under the Columbus 3D mapping system guidance

Treatment:

Device: FlashPoint renal denervation system

sham

Sham Comparator group

Description:

For those subjects randomized to the sham procedure, renal artery angiography will serve as the sham procedure. Subjects maintenance of anti-hypertensive medications.

Treatment:

Other: Sham