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

NCT05590871 | Recruiting DMC

• 1 other identifier: 714156A
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 27

Brief 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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• 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

• The incidence of Major Adverse Events (MAE)

  Safty outcome

  Baseline to 1 month

Secondary Outcomes (13)

• Reduction in office systolic and diastolic BP

  Baseline to 1, 3, 6 months post procedure

• Reduction in average 24h ambulatory diastolic BP

  Baseline to 1, 3, 6 months post procedure

• Reduction in home systolic and diastolic BP

  Baseline to 1, 2, 3, 4, 5, 6 months post procedure

• Percentage of subjects change the number, class, dose of antihypertensive drugs

  Baseline to 1, 2, 3, 4, 5, 6 months post procedure

• Difference in antihypertensive drug burden index

  Baseline to 6 months post procedure

Study Arms (2)

Renal Denervation

EXPERIMENTAL

Percutaneous renal denervation using the FlashPoint radio-frequency ablation system under the Columbus 3D mapping system guidance

Device: FlashPoint renal denervation system

sham

SHAM COMPARATOR

For those subjects randomized to the sham procedure, renal artery angiography will serve as the sham procedure. Subjects maintenance of anti-hypertensive medications.

Other: Sham

Interventions

FlashPoint renal denervation system DEVICE

Radio-frequency ablation of renal arterial sympathetic nerves

Renal Denervation

Sham OTHER

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.

sham

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Renal artery anatomy failures include:
• Renal artery diameter \<4mm or treatment length \<20mm;
• Renal artery stenosis \>50% or renal aneurysm on either side;
• 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:
• Primary pulmonary hypertension (moderate to severe);
• Type I diabetes;
• History of any cerebrovascular events (eg, stroke, transient cerebral ischemic event, cerebrovascular accident) within 3 months;
• History of any serious cardiovascular event within 3 months (eg, myocardial infarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV), unstable angina attack);
• 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);
• Arranged or planned surgery or cardiovascular intervention within the next 6 months;

Sponsors & Collaborators

• Shanghai Hongdian Medical CO., LTD: lead

Study Sites (27)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400037, China

RECRUITING

Chongqing General Hospital

Chongqing, Chongqing Municipality, 401147, China

RECRUITING

Cardiovascular Hospital Affiliated to Xiamen University

Xiamen, Fujian, 361016, China

RECRUITING

The Second Hospital of Lanzhou University

Lanzhou, Gansu, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

NOT YET RECRUITING

Guizhou Provincial People's Hospital

Guiyang, Guizhou, 550002, China

RECRUITING

First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

RECRUITING

The 7th People's Hospital of Zhengzhou

Zhengzhou, Henan, 450016, China

RECRUITING

Zhengzhou Central Hospital

Zhenzhou, Henan, China

RECRUITING

Changzhou No.2 People's Hospital

Changzhou, Jiangsu, 213003, China

RECRUITING

Ansteel Group General Hospital

Anshan, Liaoning, China

NOT YET RECRUITING

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116014, China

NOT YET RECRUITING

The First Hospital of China Medical University

Shengyang, Liaoning, 110001, China

RECRUITING

The People's Hospital of Liaoning Province

Shenyang, Liaoning, 110017, China

RECRUITING

Weifang People's Hospital

Weifang, Shandong, China

RECRUITING

Shanghai General Hospital

Shanghai, Shanghai Municipality, 201620, China

RECRUITING

The Second Affiliated Hospital of Air Force Medical University of PLA

Xi’an, Shanxi, 710038, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

First Affiliated Hospital of Chengdu Medical College

Chengdu, Sichuan, China

RECRUITING

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, 646099, China

RECRUITING

Mianyang Central Hospital

Mianyang, Sichuan, 621000, China

RECRUITING

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, 300300, China

RECRUITING

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, 300384, China

RECRUITING

First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

NOT YET RECRUITING

Yan'an Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

RECRUITING

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315016, China

RECRUITING

Shenzhen Guangming District People's Hospital

Shenzhen, China

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Yuehui Yin, MD

CONTACT

+86 13508335502; Yinyh@hospital.cqmu.edu.cn

Yingxian Sun, MD

CONTACT

+86 13804068889; yxsun@cmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 21, 2022
• Study Start: March 31, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (27)