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

Official title

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

Overview

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

• Device FlashPoint renal denervation system
  Radio-frequency ablation of renal arterial sympathetic nerves
• Other Sham
  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.

Primary outcome measures

• 24-hour ambulatory mean systolic blood pressure reduction [Time frame: Baseline to 6 months]
• The incidence of Major Adverse Events (MAE) [Time frame: Baseline to 1 month]

Secondary outcome measures (12)

• Reduction in office systolic and diastolic BP [Time frame: Baseline to 1, 3, 6 months post procedure]
• Reduction in average 24h ambulatory diastolic BP [Time frame: Baseline to 1, 3, 6 months post procedure]
• Reduction in home systolic and diastolic BP [Time frame: Baseline to 1, 2, 3, 4, 5, 6 months post procedure]
• Percentage of subjects change the number, class, dose of antihypertensive drugs [Time frame: Baseline to 1, 2, 3, 4, 5, 6 months post procedure]
• Difference in antihypertensive drug burden index [Time frame: Baseline to 6 months post procedure]
• Subjects level of TTR ( time in target BP range) [Time frame: Baseline to 6 months post procedure]
• Success rate of the renal interventional therapy procedure [Time frame: during the procedure]
• Incident of acute procedure safety events [Time frame: 7 days post procedure]
• Incident of chronic procedure safety events [Time frame: 6 months post procedure]
• Incidence of TTR with MAE, all cause death, stroke and myocardial infarction [Time frame: Baseline to 6 months post procedure]
• Incidence of adverse events [Time frame: Baseline to 6 months post procedure]
• Incident of serious adverse events [Time frame: Baseline to 6 months post procedure]

Eligibility criteria

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:

• Renal artery diameter <4mm or treatment length <20mm;
• Renal artery stenosis >50% or renal aneurysm on either side;
• 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:

• 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 who survival period is less than 1year;
• Patients with secondary hypertension.
• Patients who are deemed inappropriate to participate in this trial by other investigators.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 27 centers

• The Second Affiliated Hospital of Chongqing Medical University — Chongqing
• Chongqing General Hospital — Chongqing
• Cardiovascular Hospital Affiliated to Xiamen University — Xiamen
• The Second Hospital of Lanzhou University — Lanzhou
• Guangdong Provincial People's Hospital — Guangzhou
• Guizhou Provincial People's Hospital — Guiyang
• First Affiliated Hospital of Harbin Medical University — Harbin
• The 7th People's Hospital of Zhengzhou — Zhengzhou
• … and 19 more centers

Publications

• Long Y, Lai Y, Ren Y, Ma X, Li D, Chen L, Liao X, Xia T, Liu Z, Ling Z, Chen Y, Zhou H, Yin Y. Aorticorenal Ganglion Ablation Enhances Blood Pressure Reduction After Renal Denervation. Hypertension. 2026 Jul;83(7):e26719. doi: 10.1161/HYPERTENSIONAHA.125.26719. Epub 2026 Apr 9. PMID 41954001
• Ogoyama Y, Kario K. Differences in the effectiveness and safety of different renal denervation devices. Hypertens Res. 2024 Oct;47(10):2678-2684. doi: 10.1038/s41440-024-01801-9. Epub 2024 Jul 16. PMID 39014117

Identifiers

NCT: NCT05590871 · 714156A

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗