3D Cardiac Electrophysiological Mapping System on Renal Artery Radiofrequency Ablation System for Hypertension: a Prospective, Multicenter, Randomized Controlled Trial
Status: Recruiting
Location: See all (27) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Ansteel Group General Hospital
NOT_YET_RECRUITING
Anshan
Changzhou No.2 People's Hospital
RECRUITING
Changzhou
First Affiliated Hospital of Chengdu Medical College
RECRUITING
Chengdu
West China Hospital of Sichuan University
RECRUITING
Chengdu
Chongqing General Hospital
RECRUITING
Chongqing
The Second Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
The First Affiliated Hospital of Dalian Medical University
NOT_YET_RECRUITING
Dalian
Guangdong Provincial People's Hospital
NOT_YET_RECRUITING
Guangzhou
Guizhou Provincial People's Hospital
RECRUITING
Guiyang
First Affiliated Hospital of Harbin Medical University
RECRUITING
Harbin
Yan'an Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
The Second Hospital of Lanzhou University
RECRUITING
Lanzhou
The Affiliated Hospital of Southwest Medical University
RECRUITING
Luzhou
Mianyang Central Hospital
RECRUITING
Mianyang
The First Affiliated Hospital of Ningbo University
RECRUITING
Ningbo
Shanghai General Hospital
RECRUITING
Shanghai
The First Hospital of China Medical University
RECRUITING
Shengyang
The People's Hospital of Liaoning Province
RECRUITING
Shenyang
Shenzhen Guangming District People's Hospital
RECRUITING
Shenzhen
Tianjin Chest Hospital
RECRUITING
Tianjin
Tianjin First Central Hospital
RECRUITING
Tianjin
First Affiliated Hospital of Xinjiang Medical University
NOT_YET_RECRUITING
Ürümqi
Weifang People's Hospital
RECRUITING
Weifang
The Second Affiliated Hospital of Air Force Medical University of PLA
RECRUITING
Xi’an
Cardiovascular Hospital Affiliated to Xiamen University
RECRUITING
Xiamen
The 7th People's Hospital of Zhengzhou
RECRUITING
Zhengzhou
Zhengzhou Central Hospital
RECRUITING
Zhenzhou
Contact Information
Primary
Yuehui Yin, MD
Yinyh@hospital.cqmu.edu.cn
+86 13508335502
Backup
Yingxian Sun, MD
yxsun@cmu.edu.cn
+86 13804068889
Time Frame
Start Date:2023-03-31
Estimated Completion Date:2026-12-31
Participants
Target number of participants:180
Treatments
Experimental: Renal Denervation
Percutaneous renal denervation using the FlashPoint radio-frequency ablation system under the Columbus 3D mapping system guidance
Sham_comparator: sham
For those subjects randomized to the sham procedure, renal artery angiography will serve as the sham procedure.~Subjects maintenance of anti-hypertensive medications.