FlashPoint Renal Denervation Under Columbus 3D Mapping System Guidance for Treating Hypertension
NCT ID: NCT05590871
Last Updated: 2024-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
180 participants
INTERVENTIONAL
2023-03-31
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Renal Denervation
Percutaneous renal denervation using the FlashPoint radio-frequency ablation system under the Columbus 3D mapping system guidance
FlashPoint renal denervation system
Radio-frequency ablation of renal arterial sympathetic nerves
sham
For those subjects randomized to the sham procedure, renal artery angiography will serve as the sham procedure.
Subjects maintenance of anti-hypertensive medications.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
70 Years
ALL
No
Sponsors
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Shanghai Hongdian Medical CO., LTD
INDUSTRY
Responsible Party
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Locations
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The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Chongqing General Hospital
Chongqing, Chongqing Municipality, China
Cardiovascular Hospital Affiliated to Xiamen University
Xiamen, Fujian, China
The Second Hospital of Lanzhou University
Lanzhou, Gansu, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The 7th People's Hospital of Zhengzhou
Zhengzhou, Henan, China
Zhengzhou Central Hospital
Zhenzhou, Henan, China
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, China
Ansteel Group General Hospital
Anshan, Liaoning, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
The First Hospital of China Medical University
Shengyang, Liaoning, China
The People's Hospital of Liaoning Province
Shenyang, Liaoning, China
Weifang People's Hospital
Weifang, Shandong, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital of Air Force Medical University of PLA
Xi’an, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
First Affiliated Hospital of Chengdu Medical College
Chengdu, Sichuan, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
Mianyang Central Hospital
Mianyang, Sichuan, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, China
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, China
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Yan'an Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
Shenzhen Guangming District People's Hospital
Shenzhen, , China
Countries
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Central Contacts
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Other Identifiers
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714156A
Identifier Type: -
Identifier Source: org_study_id
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