Actively Recruiting
FlashPoint Renal Denervation Under Columbus 3D Mapping System Guidance for Treating Hypertension
Led by Shanghai Hongdian Medical CO., LTD · Updated on 2024-11-20
180
Participants Needed
27
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FlashPoint Renal Denervation Under Columbus 3D Mapping System Guidance for Treating Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 to 70 years (not pregnant, breastfeeding, and no reproductive plan within one year)
- Patients with essential hypertension intolerant to antihypertensive drugs and willing to undergo surgical treatment
- 24-hour average systolic blood pressure ≥130 mmHg or daytime systolic blood pressure ≥135 mmHg, with pulse pressure difference less than 80 mmHg
- History of antihypertensive medication use within six months with uncontrolled blood pressure
- Standardized medication with at least two drugs for at least 28 days before enrollment, medication compliance ≥80%, office systolic blood pressure between 150 and less than 180 mmHg, and diastolic blood pressure ≥90 mmHg
- Agreement to participate and sign informed consent, with willingness to follow-up as required by the protocol
You will not qualify if you...
- Renal artery diameter less than 4 mm or treatment length less than 20 mm
- Renal artery stenosis greater than 50% or renal aneurysm on either side
- History of renal artery intervention including balloon angioplasty, stenting, or renal denervation
- Glomerular filtration rate (eGFR) less than 45 mL/min/1.73m2
- Hospitalization for hypertensive crisis in the past year
- Use of antihypertensive drugs other than those prescribed in this study during screening and lead-in
- Nocturnal sleep apnea syndrome requiring mechanical ventilation
- Moderate to severe primary pulmonary hypertension
- Type I diabetes
- History of cerebrovascular events (stroke, transient ischemic attack, cerebrovascular accident) within 3 months
- History of serious cardiovascular events (myocardial infarction, coronary artery bypass graft, acute heart failure NYHA III-IV, unstable angina) within 3 months
- Conditions interfering with blood pressure measurement such as severe peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders, or severe anemia
- Planned surgery or cardiovascular intervention within 6 months
- Malignant tumors or end-stage diseases with life expectancy less than 1 year
- Secondary hypertension
- Other investigator-determined reasons deeming participation inappropriate
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 27 locations
1
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400037
Actively Recruiting
2
Chongqing General Hospital
Chongqing, Chongqing Municipality, China, 401147
Actively Recruiting
3
Cardiovascular Hospital Affiliated to Xiamen University
Xiamen, Fujian, China, 361016
Actively Recruiting
4
The Second Hospital of Lanzhou University
Lanzhou, Gansu, China
Actively Recruiting
5
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Not Yet Recruiting
6
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China, 550002
Actively Recruiting
7
First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150001
Actively Recruiting
8
The 7th People's Hospital of Zhengzhou
Zhengzhou, Henan, China, 450016
Actively Recruiting
9
Zhengzhou Central Hospital
Zhenzhou, Henan, China
Actively Recruiting
10
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, China, 213003
Actively Recruiting
11
Ansteel Group General Hospital
Anshan, Liaoning, China
Not Yet Recruiting
12
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China, 116014
Not Yet Recruiting
13
The First Hospital of China Medical University
Shengyang, Liaoning, China, 110001
Actively Recruiting
14
The People's Hospital of Liaoning Province
Shenyang, Liaoning, China, 110017
Actively Recruiting
15
Weifang People's Hospital
Weifang, Shandong, China
Actively Recruiting
16
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 201620
Actively Recruiting
17
The Second Affiliated Hospital of Air Force Medical University of PLA
Xi’an, Shanxi, China, 710038
Actively Recruiting
18
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
19
First Affiliated Hospital of Chengdu Medical College
Chengdu, Sichuan, China
Actively Recruiting
20
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China, 646099
Actively Recruiting
21
Mianyang Central Hospital
Mianyang, Sichuan, China, 621000
Actively Recruiting
22
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, China, 300300
Actively Recruiting
23
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, China, 300384
Actively Recruiting
24
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Not Yet Recruiting
25
Yan'an Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Actively Recruiting
26
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China, 315016
Actively Recruiting
27
Shenzhen Guangming District People's Hospital
Shenzhen, China
Actively Recruiting
Research Team
Y
Yuehui Yin, MD
CONTACT
Y
Yingxian Sun, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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