Tests a renal denervation device guided by 3D mapping for high blood pressure
Tests a device-based procedure on kidney nerves in adults aged 18 to 70 with hypertension.
Plain-language title generated from the registry record
Registry title: FlashPoint Renal Denervation Under Columbus 3D Mapping System Guidance for Treating Hypertension
Key facts
- Where
- Anshan, Changzhou, Chengdu, Chongqing, Dalian, Guangzhou, Guiyang, Harbin, Kunming, Lanzhou, Luzhou, Mianyang, Ningbo, Shanghai, Shengyang, Shenyang, Shenzhen, Tianjin, Ürümqi, Weifang, Xi’an, Xiamen, Zhengzhou, and Zhenzhou, ChinaSee the 27 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT05590871, who can take part
Where in China
- Ansteel Group General HospitalAnshan, ChinaNot yet recruiting
- Changzhou No.2 People's HospitalChangzhou, ChinaTaking people
- First Affiliated Hospital of Chengdu Medical CollegeChengdu, ChinaTaking people
- West China Hospital of Sichuan UniversityChengdu, ChinaTaking people
- Chongqing General HospitalChongqing, ChinaTaking people
- The Second Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaTaking people
- The First Affiliated Hospital of Dalian Medical UniversityDalian, ChinaNot yet recruiting
- Guangdong Provincial People's HospitalGuangzhou, ChinaNot yet recruiting
- Guizhou Provincial People's HospitalGuiyang, ChinaTaking people
- First Affiliated Hospital of Harbin Medical UniversityHarbin, ChinaTaking people
- Yan'an Affiliated Hospital of Kunming Medical UniversityKunming, ChinaTaking people
- The Second Hospital of Lanzhou UniversityLanzhou, ChinaTaking people
- The Affiliated Hospital of Southwest Medical UniversityLuzhou, ChinaTaking people
- Mianyang Central HospitalMianyang, ChinaTaking people
- The First Affiliated Hospital of Ningbo UniversityNingbo, ChinaTaking people
- Shanghai General HospitalShanghai, ChinaTaking people
- The First Hospital of China Medical UniversityShengyang, ChinaTaking people
- The People's Hospital of Liaoning ProvinceShenyang, ChinaTaking people
- Shenzhen Guangming District People's HospitalShenzhen, ChinaTaking people
- Tianjin Chest HospitalTianjin, ChinaTaking people
- Tianjin First Central HospitalTianjin, ChinaTaking people
- First Affiliated Hospital of Xinjiang Medical UniversityÜrümqi, ChinaNot yet recruiting
- Weifang People's HospitalWeifang, ChinaTaking people
- The Second Affiliated Hospital of Air Force Medical University of PLAXi’an, ChinaTaking people
- Cardiovascular Hospital Affiliated to Xiamen UniversityXiamen, ChinaTaking people
- The 7th People's Hospital of ZhengzhouZhengzhou, ChinaTaking people
- Zhengzhou Central HospitalZhenzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Hongdian Medical CO., LTD
- Trial code
- NCT05590871
- Record updated
- 20 November 2024
- Original description
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.Read full original descriptionShow less
3D Cardiac Electrophysiological Mapping System on Renal Artery Radiofrequency Ablation System for Hypertension: a Prospective, Multicenter, Randomized Controlled Trial
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.
Inclusion: 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: During the screening and lead-in period, the patient used antihypertensive drugs other than the standard antihypertensive drugs prescribed in this study protocol; 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; History of hospitalization for hypertensive crisis in the past year; 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; Glomerular filtration rate (eGFR) <45mL/min/1.73m2 (MDRD formula); Patients who are deemed inappropriate to participate in this trial by other investigators.