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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT05590871

Run by

Shanghai Hongdian Medical CO., LTD

People needed

180

Starts

2023-03-31

Expected to finish

2026-12-31

Last updated by the study team

2024-11-20

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Second Affiliated Hospital of Air Force Medical University of PLA — Xi’an, Shanxi, China (enrolling)
• First Affiliated Hospital of Chengdu Medical College — Chengdu, Sichuan, China (enrolling)
• The Affiliated Hospital of Southwest Medical University — Luzhou, Sichuan, China (enrolling)
• Mianyang Central Hospital — Mianyang, Sichuan, China (enrolling)
• Tianjin Chest Hospital — Tianjin, Tianjin Municipality, China (enrolling)
• Tianjin First Central Hospital — Tianjin, Tianjin Municipality, China (enrolling)
• The People's Hospital of Liaoning Province — Shenyang, Liaoning, China (enrolling)
• Weifang People's Hospital — Weifang, Shandong, China (enrolling)
• Shanghai General Hospital — Shanghai, Shanghai Municipality, China (enrolling)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (enrolling)
• Yan'an Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (enrolling)
• The First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China (enrolling)
• Shenzhen Guangming District People's Hospital — Shenzhen, China (enrolling)
• The Second Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (enrolling)
• Chongqing General Hospital — Chongqing, Chongqing Municipality, China (enrolling)
• Cardiovascular Hospital Affiliated to Xiamen University — Xiamen, Fujian, China (enrolling)
• The Second Hospital of Lanzhou University — Lanzhou, Gansu, China (enrolling)
• Guizhou Provincial People's Hospital — Guiyang, Guizhou, China (enrolling)
• First Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (enrolling)
• The 7th People's Hospital of Zhengzhou — Zhengzhou, Henan, China (enrolling)
• Zhengzhou Central Hospital — Zhenzhou, Henan, China (enrolling)
• Changzhou No.2 People's Hospital — Changzhou, Jiangsu, China (enrolling)
• The First Hospital of China Medical University — Shengyang, Liaoning, China (enrolling)
• First Affiliated Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China
• Ansteel Group General Hospital — Anshan, Liaoning, China

Full record on ClinicalTrials.gov

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