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Clinical Trials in China / NCT05590871
Recruiting Not applicable

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

NCT05590871 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Hongdian Medical CO., LTD
Phase
Not applicable
Started
2023-03-31
Last updated
2024-11-20

Condition(s) studied

Hypertension

Investigational drug(s) / intervention(s)

FlashPoint renal denervation systemSham

FlashPoint renal denervation system: Radio-frequency ablation of renal arterial sympathetic nerves

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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.

Primary outcome measure(s)

Trial sites (27)

FacilityCityRegionStatus
The Second Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality Recruiting
Chongqing General Hospital Chongqing Chongqing Municipality Recruiting
Cardiovascular Hospital Affiliated to Xiamen University Xiamen Fujian Recruiting
The Second Hospital of Lanzhou University Lanzhou Gansu Recruiting
Guangdong Provincial People's Hospital Guangzhou Guangdong Not Yet Recruiting
Guizhou Provincial People's Hospital Guiyang Guizhou Recruiting
First Affiliated Hospital of Harbin Medical University Harbin Heilongjiang Recruiting
The 7th People's Hospital of Zhengzhou Zhengzhou Henan Recruiting
Zhengzhou Central Hospital Zhenzhou Henan Recruiting
Changzhou No.2 People's Hospital Changzhou Jiangsu Recruiting
Ansteel Group General Hospital Anshan Liaoning Not Yet Recruiting
The First Affiliated Hospital of Dalian Medical University Dalian Liaoning Not Yet Recruiting
The First Hospital of China Medical University Shengyang Liaoning Recruiting
The People's Hospital of Liaoning Province Shenyang Liaoning Recruiting
Weifang People's Hospital Weifang Shandong Recruiting
Shanghai General Hospital Shanghai Shanghai Municipality Recruiting
The Second Affiliated Hospital of Air Force Medical University of PLA Xi’an Shanxi Recruiting
West China Hospital of Sichuan University Chengdu Sichuan Recruiting
First Affiliated Hospital of Chengdu Medical College Chengdu Sichuan Recruiting
The Affiliated Hospital of Southwest Medical University Luzhou Sichuan Recruiting
Mianyang Central Hospital Mianyang Sichuan Recruiting
Tianjin Chest Hospital Tianjin Tianjin Municipality Recruiting
Tianjin First Central Hospital Tianjin Tianjin Municipality Recruiting
First Affiliated Hospital of Xinjiang Medical University Ürümqi Xinjiang Not Yet Recruiting
Yan'an Affiliated Hospital of Kunming Medical University Kunming Yunnan Recruiting
The First Affiliated Hospital of Ningbo University Ningbo Zhejiang Recruiting
Shenzhen Guangming District People's Hospital Shenzhen China Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05590871 on ClinicalTrials.gov ↗ ← All trials in China