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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05590871
• Other study ID #: 714156A
• Status: Recruiting
• Phase: N/A
• Start date: March 31, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Shanghai Hongdian Medical CO., LTD
• Contact: Yuehui Yin, MD
• Phone: +86 13508335502
• Email: Yinyh[@]hospital.cqmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This trial is a prospective, multi-center, randomized controlled clinical study to verify the safety and efficacy of the renal artery radiofrequency ablation system under the guidance of the three-dimensional cardiac electrophysiological mapping system in the application of renal denervation of essential hypertension. Provide the basis for product registration and marketing and clinical application. This trial plans to include 185 subjects, of which 5 are subjects trained and taught by the experimental group leader unit center, and 180 subjects are randomly assigned according to 2:1 (120 cases in the renal artery ablation group and 60 cases in the simple drug treatment group).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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 three drugs, including diuretic) for at least 28 days before enrollment, and medication compliance = 80%, office systolic blood pressure (OSBP) ) = 140 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:

• Renal artery anatomy failures include:

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 breathing chronic oxygen or mechanical ventilation (such as tracheostomy);

• Patients with contraindications to renal artery stimulation or ablation;

• 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;

• Patients with secondary hypertension.

• Patients who are deemed inappropriate to participate in this trial by other investigators.

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• FlashPoint renal denervation system
Radio-frequency ablation of renal arterial sympathetic nerves

Locations

Country	Name	City	State
China	Ansteel Group General Hospital	Anshan	Liaoning
China	Changzhou No.2 People's Hospital	Changzhou	Jiangsu
China	First Affiliated Hospital of Chengdu Medical College	Chendu	Sichuan
China	West China Hospital of Sichuan University	Chendu	Sichuan
China	Chongqing General Hospital	Chongqing	Chongqing
China	The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	Guizhou Provincial People's Hospital	Guiyang	Guizhou
China	First Affiliated Hospital of Harbin Medical University	Ha'erbin	Heilongjiang
China	Yan'an Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	The Second Hospital of Lanzhou University	Lanzhou	Gansu
China	The Affiliated Hospital of Southwest Medical University	Luzhou	Sichuan
China	Mianyang Central Hospital	Mianyang	Sichuan
China	The First Affiliated Hospital of Ningbo University	Ningbo	Zhejiang
China	Shanghai General Hospital	Shanghai	Shanghai
China	The First Hospital of China Medical University	Shengyang	Liaoning
China	The People's Hospital of Liaoning Province	Shenyang	Liaoning
China	Shenzhen Guangming District People's Hospital	Shenzhen
China	Tianjin Chest Hospital	Tianjin	Tianjin
China	Tianjin First Central Hospital	Tianjin	Tianjin
China	First Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiang
China	Weifang People's Hospital	Weifang	Shandong
China	The Second Affiliated Hospital of Air Force Medical University of PLA	Xi'an	Shanxi
China	Cardiovascular Hospital Affiliated to Xiamen University	Xiamen	Fujian
China	The 7th People's Hospital of Zhengzhou	Zhengzhou	Henan
China	Zhengzhou Central Hospital	Zhenzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Hongdian Medical CO., LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour ambulatory mean systolic blood pressure reduction	The primary effectiveness endpoint is change in 24-hour ambulatory mean systolic blood pressure from baseline to 6 months post-randomization	Baseline to 6 months