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HypertensionNCT05590871

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

A study testing FlashPoint renal denervation system in people with Hypertension, run by Shanghai Hongdian Medical CO., LTD at 27 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hypertension
What is being tested?
FlashPoint renal denervation system
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
27 sitesChina
Study dates
31 Mar 2023to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 18Show fewer
  • 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;
  • 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.

Trial locations and contacts

27 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yuehui Yin, MD contact

+86 13508335502

Yinyh@hospital.cqmu.edu.cn

Yingxian Sun, MD contact

+86 13804068889

yxsun@cmu.edu.cn

27 sites in 1 country

China27 sites, 27 recruiting

  • Ansteel Group General Hospital

    Anshan, Liaoning

    Not yet recruiting

  • Changzhou No.2 People's Hospital

    Changzhou, Jiangsu, 213003

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

    Recruiting

  • First Affiliated Hospital of Chengdu Medical College

    Chengdu, Sichuan

    Recruiting

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400037

    Recruiting

  • Chongqing General Hospital

    Chongqing, Chongqing Municipality, 401147

    Recruiting

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116014

    Not yet recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

    Not yet recruiting

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou, 550002

    Recruiting

  • First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

    Recruiting

  • Yan'an Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

    Recruiting

  • The Second Hospital of Lanzhou University

    Lanzhou, Gansu

    Recruiting

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan, 646099

    Recruiting

  • Mianyang Central Hospital

    Mianyang, Sichuan, 621000

    Recruiting

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, 315016

    Recruiting

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 201620

    Recruiting

  • The First Hospital of China Medical University

    Shengyang, Liaoning, 110001

    Recruiting

  • The People's Hospital of Liaoning Province

    Shenyang, Liaoning, 110017

    Recruiting

  • Shenzhen Guangming District People's Hospital

    Shenzhen

    Recruiting

  • Tianjin Chest Hospital

    Tianjin, Tianjin Municipality, 300300

    Recruiting

  • Tianjin First Central Hospital

    Tianjin, Tianjin Municipality, 300384

    Recruiting

  • First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang

    Not yet recruiting

  • Weifang People's Hospital

    Weifang, Shandong

    Recruiting

  • The Second Affiliated Hospital of Air Force Medical University of PLA

    Xi’an, Shanxi, 710038

    Recruiting

  • Cardiovascular Hospital Affiliated to Xiamen University

    Xiamen, Fujian, 361016

    Recruiting

  • The 7th People's Hospital of Zhengzhou

    Zhengzhou, Henan, 450016

    Recruiting

  • Zhengzhou Central Hospital

    Zhenzhou, Henan

    Recruiting

Other trials in China

About this study

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

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.

Read the detailed 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，designed to include drug-control research and sham-control resarch. Provide the basis for product registration and marketing and clinical application. Drug-control research include 65 subiects (5 are subjects trained and taught by the experimental group leader unit center, 40 subjects are randomly to the renal artery ablation with durg treatment group, 20 subjects to the drug treatment group). Sham-control research include 180 subjects, will be randomly assigned according to 2:1 (120 subjects in the renal artery ablation with drug treatment group and 60 subjects in the sham procedure with 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.

Conditions
Hypertension
Being tested
FlashPoint renal denervation system, Sham
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FlashPoint renal denervation systemDevice

    Radio-frequency ablation of renal arterial sympathetic nerves

  • ShamOther

    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.

Study groups in NCT05590871
Study groupRoleWhat they receive
Renal DenervationExperimentalPercutaneous renal denervation using the FlashPoint radio-frequency ablation system under the Columbus 3D mapping system guidance
Receives: Device: FlashPoint renal denervation system
shamSham comparatorFor those subjects randomized to the sham procedure, renal artery angiography will serve as the sham procedure. Subjects maintenance of anti-hypertensive medications.
Receives: Other: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline to 6 months

  2. The incidence of Major Adverse Events (MAE)

    Safty outcome

    Measured: Baseline to 1 month

Secondary outcomes (13)

  1. Reduction in office systolic and diastolic BP

    Secondary outcome

    Measured: Baseline to 1, 3, 6 months post procedure

  2. Reduction in average 24h ambulatory diastolic BP

    Measured: Baseline to 1, 3, 6 months post procedure

  3. Reduction in home systolic and diastolic BP

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

  4. Percentage of subjects change the number, class, dose of antihypertensive drugs

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

  5. Difference in antihypertensive drug burden index

    Measured: Baseline to 6 months post procedure

  6. Subjects level of TTR ( time in target BP range)

    Measured: Baseline to 6 months post procedure

  7. Success rate of the renal interventional therapy procedure

    Procedure success rate defined as successful introduction of the catheter, navigation to the treatment site, and there are no procedure-related SAE.

    Measured: during the procedure

  8. Incident of acute procedure safety events

    Measured: 7 days post procedure

  9. Incident of chronic procedure safety events

    Measured: 6 months post procedure

  10. Incidence of TTR with MAE, all cause death, stroke and myocardial infarction

    Measured: Baseline to 6 months post procedure

  11. Incidence of adverse events

    Measured: Baseline to 6 months post procedure

  12. Incident of serious adverse events

    Measured: Baseline to 6 months post procedure

  13. Ablation system defect rate

    Measured: During procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2022
  2. Study start31 Mar 2023
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05590871
Sponsor's protocol ID
714156A
Status last verified
Nov 2024
First submitted
19 Oct 2022
Last updated
20 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Long Y, Lai Y, Ren Y, Ma X, Li D, Chen L, Liao X, Xia T, Liu Z, Ling Z, Chen Y, Zhou H, Yin Y. Aorticorenal Ganglion Ablation Enhances Blood Pressure Reduction After Renal Denervation. Hypertension. 2026 Jul;83(7):e26719. doi: 10.1161/HYPERTENSIONAHA.125.26719. Epub 2026 Apr 9.

    PubMed 41954001

  • Ogoyama Y, Kario K. Differences in the effectiveness and safety of different renal denervation devices. Hypertens Res. 2024 Oct;47(10):2678-2684. doi: 10.1038/s41440-024-01801-9. Epub 2024 Jul 16.

    PubMed 39014117

Questions about this trial

What is this clinical trial studying?

A study testing FlashPoint renal denervation system in people with Hypertension, run by Shanghai Hongdian Medical CO., LTD at 27 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yuehui Yin, MD (+86 13508335502, Yinyh@hospital.cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

24-hour ambulatory mean systolic blood pressure reduction (time frame: Baseline to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05590871, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.

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