RecruitingNot ApplicableNCT05590871

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

3D Cardiac Electrophysiological Mapping System on Renal Artery Radiofrequency Ablation System for Hypertension: a Prospective, Multicenter, Randomized Controlled Trial

Sponsor

Shanghai Hongdian Medical CO., LTD

Enrollment

180 participants

Start Date

Mar 31, 2023

Study Type

INTERVENTIONAL

Conditions

Hypertension

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a procedure called renal denervation — where nerves around the kidney arteries are inactivated using a special catheter — to treat high blood pressure that isn't controlled by medications. A 3D mapping system is used to guide the procedure with greater precision. **You may be eligible if...** - You are 18–70 years old - You have high blood pressure that remains uncontrolled despite taking at least two blood pressure medications for at least 28 days - Your average 24-hour blood pressure (on ambulatory monitoring) is above 130/85 mmHg - You are willing to undergo a minimally invasive procedure **You may NOT be eligible if...** - Your kidney arteries are too narrow or too small for the procedure - Your kidney function is significantly reduced (eGFR below 45) - You have been hospitalized for a hypertensive crisis recently - You have had prior kidney artery procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEFlashPoint renal denervation system

Radio-frequency ablation of renal arterial sympathetic nerves

OTHERSham

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.

Locations(27)

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05590871

Related Trials

Study of Efficacy and Safety of Tonlamarsen in Participants With Acute Severe Hypertension Recently Discharged From the Hospital

NCT075113614 locations

Supporting VETerans With Kidney Disease Through Food As Medicine

NCT071947331 location