Hypertension
Conditions
Brief summary
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
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.
Interventions
DEVICEFlashPoint renal denervation system
Radio-frequency ablation of renal arterial sympathetic nerves
OTHERSham
After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Sponsors
Shanghai Hongdian Medical CO., LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour ambulatory mean systolic blood pressure reduction | Baseline to 6 months | The primary effectiveness endpoint is change in 24-hour ambulatory mean systolic blood pressure from baseline to 6 months post-randomization |
| The incidence of Major Adverse Events (MAE) | Baseline to 1 month | Safty outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in home systolic and diastolic BP | Baseline to 1, 2, 3, 4, 5, 6 months post procedure | — |
| Percentage of subjects change the number, class, dose of antihypertensive drugs | Baseline to 1, 2, 3, 4, 5, 6 months post procedure | — |
| Difference in antihypertensive drug burden index | Baseline to 6 months post procedure | — |
| Subjects level of TTR ( time in target BP range) | Baseline to 6 months post procedure | — |
| Success rate of the renal interventional therapy procedure | during the procedure | Procedure success rate defined as successful introduction of the catheter, navigation to the treatment site, and there are no procedure-related SAE. |
| Reduction in office systolic and diastolic BP | Baseline to 1, 3, 6 months post procedure | Secondary outcome |
| Incident of chronic procedure safety events | 6 months post procedure | — |
| Incidence of TTR with MAE, all cause death, stroke and myocardial infarction | Baseline to 6 months post procedure | — |
| Incidence of adverse events | Baseline to 6 months post procedure | — |
| Incident of serious adverse events | Baseline to 6 months post procedure | — |
| Ablation system defect rate | During procedure | — |
| Incident of acute procedure safety events | 7 days post procedure | — |
| Reduction in average 24h ambulatory diastolic BP | Baseline to 1, 3, 6 months post procedure | — |
Countries
China
Contacts
Primary ContactYuehui Yin, MD
Backup ContactYingxian Sun, MD
Outcome results
None listed